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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000673-12 | EudraCT Number |
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| Name | Class |
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| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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M3814 was an investigational drug that is being evaluated for the treatment of participants with locally advanced tumors. The main purposes of this study was to determine the safety, the tolerability and the efficacy of M3814 in combination with radiotherapy and in combination with chemoradiotherapy (Radiotherapy + cisplatin).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1a (Arm A): M3814 Capsule (100 mg) + RT | Experimental | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative radiotherapy (RT) received 100 milligrams (mg) of M3814 as capsule orally once daily on fraction day (FD) 6 in combination with RT (3 Gray [Gy] x 10, 5 fractions per week [F/W]). |
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| Phase 1a (Arm A): M3814 Capsule (200 mg) + RT | Experimental | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
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| Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Experimental | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
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| Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M3814 100 mg | Drug | Participants received 100 mg of M3814 as capsule or tablet orally once daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a (Arm A): Number of Participants Who Experienced at Least One Dose-limiting Toxicity (DLT) According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) | DLT: any Grade (Gr) greater than or equal to (>=) 3 nonhematologic adverse event (AE)/any Gr>=4 hematologic AE that is related to any of study treatments and occurs during the DLT period of 5 weeks (Phase Ia, Arm A) after the first dose of M3814. Following are considered as DLTs: Gr3 thrombocytopenia with medically concerning bleeding; Febrile neutropenia; Any toxicity/study treatment-related adverse event (TEAE) that, in opinion of Safety Monitoring Committee (SMC), is of potential clinical significance such that further dose escalation would expose participants to unacceptable risk; Any toxicity related to study treatments that causes participant to receive less than 80 percent (%) of the planned RT dose; Evidence of study treatment-related hepatocellular injury for > 3 days. | Time from first dose of study treatment up to 5 weeks |
| Phase 1a (Arm B): Number of Participants Who Experienced at Least One Dose-limiting Toxicity (DLT) According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) | DLT: any Grade (Gr) greater than or equal to (>=) 3 nonhematologic AE/any Gr>=4 hematologic AE that is related to any of study treatments and occurs during the DLT period of 12 weeks (Phase Ia, Arm B) after the first dose of M3814. Following are considered as DLTs: Gr3 thrombocytopenia with medically concerning bleeding; Febrile neutropenia; Any toxicity/study treatment-related adverse event (TEAE) that, in opinion of Safety Monitoring Committee (SMC), is of potential clinical significance such that further dose escalation would expose participants to unacceptable risk; Any toxicity related to study treatments that causes participant to receive less than 80 percent (%) of the planned RT dose; Any toxicity related to study treatments leading to an interruption of RT longer than 1 week in Arm B; Evidence of study treatment-related hepatocellular injury for > 3 days. | Time from first dose of study treatment up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a (Arm A and Arm B): Number of Participants With Grade Greater Than or Equal to (>=) 3 Treatment-Emergent Adverse Events (TEAEs) According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) | Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily have a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious AEs and non-serious AEs. As per NCI-CTCAE v4.03, Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death. Number of participants with Grade >=3 TEAEs were reported. |
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Inclusion Criteria:
Exclusion Criteria:
Chemotherapy, immunotherapy, hormonal therapy, biologic therapy, or any other anticancer therapy or investigational medicinal product (IMP) within 28 days of first trial drug intake for Phase Ia subjects, and any prior therapy for Phase Ib subjects. For subjects with rapidly growing tumors localized in the head and neck region or thorax where the treating physician cannot wait for 28 days, inclusion may take place if there is no residual toxicity from previous treatment (maximum CTCAE Grade 1)
Prior RT to the same region within 12 months (Phase Ia, Arm A; subjects with tumors localized in the head and neck region or thorax) or at any time previously (Phase Ia, Arm B; treatment-naïve subjects with SCCHN and Phase Ib; treatment-naïve subjects with Stage III A/B NSCLC or SCCHN)
Extensive prior RT on ≥30% of bone marrow reserve as judged by the investigator or prior bone marrow/stem cell transplantation within 5 years before trial start.
Poor vital organ functions defined as:
History of difficulty swallowing, malabsorption or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the IMP, use of percutaneous endoscopic gastrostomy (PEG) tubes
Significant cardiac conduction abnormalities, including a history of long QTc syndrome and/or pacemaker, or impaired cardiovascular function such as New York Heart Association classification score >2.
Subjects currently receiving (or unable to stop using prior to receiving the first dose of trial drug) medications or herbal supplements known to be potent inhibitors of cytochrome P450 (CYP)3A or CYP2C19 (must stop at least 1 week prior), potent inducers of CYP3A or CYP2C19 (must stop at least 3 weeks prior), or drugs mainly metabolized by CYP3A with a narrow therapeutic index (must stop at least one day prior).
Subjects currently receiving H2-blocker or proton pump inhibitors (or unable to stop at least 5 days prior to the first treatment).
If the planned radiation field includes any part of the esophagus and the subject has symptoms of ongoing esophagitis, the subject is not eligible, unless an esophageal endoscopy rules out the presence of esophagitis
Subjects where more than 10% of the total esophagus volume receives more than 50% of the prescribed RT dose
Main exclusion criteria for Ancillary Clinical Proof-of-Principle Part:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Fresno | California | 93720 | United States | ||
| Holy Cross Hospital Inc. |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| US Medical Information website, Medical Resources | View source |
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We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
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The study was planned to be conducted in 3 parts: Phase Ia (dose escalation), Phase Ib (dose expansion) and Ancillary clinical proof-of-principle (cPoP). Phase Ib part of the study was never initiated due to early discontinuation as per sponsor's decision.
First Participant First Visit (FPFV): 15 September 2015; Last Participant last Visit (LPLV): 19 November 2021
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1a (Arm A): M3814 Capsule (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative radiotherapy (RT) received 100 milligrams (mg) of M3814 as capsule orally once daily on fraction day (FD) 6 in combination with RT (3 Gray [Gy] x 10, 5 fractions per week [F/W]). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 31, 2019 | Nov 20, 2023 |
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Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
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| Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Experimental | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
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| Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Experimental | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
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| Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Experimental | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
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| Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Experimental | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
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| Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Experimental | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
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| Ancillary cPoP: M3814 Capsule (100 mg) + RT | Experimental | Participants with at least 2 (sub)cutaneous tumor/metastases of any type (at least 2 centimeters [cm] apart) with an indication for single high dose-palliative RT were included and received single oral dose of M3814 capsule at a dose of 100 mg on Day 2, prior 1.5 hours start of RT and a single high dose of RT (10-25 Gy) on Lesion 1 on Day 1 and on Lesion 2 on Day 2. |
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| Ancillary cPOP: M3814 Capsule (200 mg) + RT | Experimental | Participants with at least 2 (sub)cutaneous tumor/metastases of any type (at least 2 cm apart) with an indication for single high dose-palliative RT were included and received single oral dose of M3814 capsule at a dose of 200 mg on Day 2, prior 1.5 hours start of RT and a single high dose of RT (10-25 Gy) on Lesion 1 on Day 1 and on Lesion 2 on Day 2. |
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| Ancillary cPOP: M3814 Capsule (400 mg) + RT | Experimental | Participants with at least 2 (sub)cutaneous tumor/metastases of any type (at least 2 cm apart) with an indication for single high dose-palliative RT were included and received single oral dose of M3814 capsule at a dose of 400 mg on Day 2, prior 1.5 hours start of RT and a single high dose of RT (10-25 Gy) on Lesion 1 on Day 1 and on Lesion 2 on Day 2 |
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| M3814 200 mg | Drug | Participants received 200 mg of M3814 as capsule or tablet orally once daily. |
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| M3814 300 mg | Drug | Participants received 300 mg of M3814 as capsule or tablet orally once daily. |
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| M3814 400 mg | Drug | Participants received 400 mg of M3814 as capsule or tablet orally once daily. |
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| M3814 50 mg | Drug | Participants received 100 mg of M3814 as capsule orally once daily. |
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| Fractionated RT | Radiation | Participants received fractionated palliative RT (3 Gray [Gy] * 10 in Arm A and 2 Gy * 33 to 35, 5 fractions per week [F/W]) in Arm B and received a single high dose of RT (10-25 Gy) capsule on Day 1 given on Lesion 1 and a single high dose of RT (10-25 Gy) on Day 2 given on Lesion 2 in ancillary CPoP part. |
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| Cisplatin | Drug | Participants received Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 mg/m^2. |
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| Time from first dose of study treatment up to long term safety follow-up period (Up to approximately 1 year) |
| Phase 1a (Arm A and Arm B): Number of Participants With Shifts From Baseline to Worst Post-Baseline Grade in Hematology Parameters According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTC v4.03) | Number of participants with shifts from Baseline values (Grade 0/1/2) to worst post-baseline values (Grade 1/2/3/4) were reported as per NCI-CTCAE, v4.03 graded from Grade 1 to 5. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death. Shifts in hematology parameter (hemoglobin low, leukocytes low, lymphocytes low, neutrophil count decreased, and platelet count decreased) were reported. | Time from first dose of study treatment up to long term safety follow-up period (Up to approximately 1 year) |
| Phase 1a (Arm A and Arm B): Number of Participants With Shifts From Baseline to Worst Post-Baseline Grade in Biochemistry Parameters According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) | Number of participants with shifts from Baseline values (Grade 0/1/2) to worst post-baseline values (Grade 1/2/3/4) were reported as per NCI-CTCAE, v4.03 graded from Grade 1 to 5. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death. Shifts in biochemistry parameter (phosphate low, potassium low, sodium low, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, blood bilirubin increased, glucose high, glucose low, albumin low and creatinine increased) were reported. | Time from first dose of study treatment up to long term safety follow-up period (Up to approximately 1 year) |
| Phase 1a (Arm A and Arm B): Number of Participants With Markedly Abnormal Vital Sign Measurements | Vital sign assessments included assessments of heart rate, blood pressure, body weight and body temperature. Abnormal vital sign measurement was decided by Investigator. Number of participants with markedly abnormal vital sign measurements were reported. | Time from first dose of study treatment up to long term safety follow-up period (Up to approximately 1 year) |
| Phase 1a (Arm A and Arm B): Number of Participants With Shifts From Normal Baseline to Abnormal Post-baseline in Electrocardiogram (ECG) | Electrocardiograms (ECG) was obtained after the participant has been in a supine position for at least 5 minutes. ECG parameters included heart rate, atrial ventricular conduction, QR and QT intervals (including QTcF), and possible arrhythmias. Any ECG finding that was judged by the investigator as a abnormal (worsening) compared with a baseline value was considered an adverse event. Number of participants with shifts from normal baseline values to abnormal post-baseline values in ECG were reported. | Time from first dose of study treatment up to long term safety follow-up period (Up to approximately 1 year) |
| Phase 1a (Arm A and Arm B): Number of Participants With Confirmed Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator | Confirmed BOR was defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. CR or PR must be confirmed by a subsequent tumor assessment, at least 4 weeks after initial documentation of CR or PR. | Time from first dose of study treatment up to long term safety follow-up period (Up to approximately 1 year) |
| Phase 1a (Arm A and Arm B): Number of Participants With Unconfirmed Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator | Unconfirmed BOR was defined as unconfirmed best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | Time from first dose of study treatment up to long term safety follow-up period (Up to approximately 1 year) |
| Phase 1a (Arm A and Arm B): Median Percent Change From Baseline in Tumor Size Measurement According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator | The tumor size was defined as the sum of the longest diameters for the target lesions. The sum of lesion diameters was calculated using RECIST v1.1 and was assessed by Investigator. | Time from first dose of study treatment up to long term safety follow-up period (Up to approximately 1 year) |
| Phase 1a (Arm A and Arm B): Maximum Plasma Concentration (Cmax) of M3814 After Single Dose | Cmax was taken directly from the observed concentration-time curve. | Pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Fraction Day 1 and Fraction Day 6 |
| Phase 1a (Arm A and Arm B): Time to Reach Maximum Plasma Concentration (Tmax) of M3814 After Single Dose | tmax was obtained directly from the concentration versus time curve. | Pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Fraction Day 1 and Fraction Day 6 |
| Phase 1a (Arm A and Arm B): Area Under the Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24) of M3814 After Single Dose | AUC0-24 of M3814 was defined as the area under the concentration time curve from time 0 to 24 hours post-dose. | Pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post-dose on Fraction Day 1 and Fraction Day 6 |
| Phase 1a (Arm A and Arm B): Area Under the Plasma Concentration-Time From Time Zero Extrapolated to Infinity (AUC0-inf) of M3814 After Single Dose | The AUC from time zero (dosing time) extrapolated to infinity, based on the predicted value for the concentration at tlast, as estimated using the linear regression from the determination of the terminal first order (elimination) rate constant (lambda z). AUC0-inf = AUC0-t plus Clast pred/lambda z. Lambda z was terminal elimination rate constant determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve. | Pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Fraction Day 1 and Fraction Day 6 |
| Phase 1a (Arm A and Arm B): Apparent Terminal Half Life (t1/2) of M3814 After Single Dose | t1/2 was the time measured for the concentration to decrease by one half. t1/2 was calculated by natural log 2 divided by Lambda z. | Pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Fraction Day 1 and Fraction Day 6 |
| Phase 1a (Arm A and Arm B): Total Body Clearance Following Oral Administration (CL/f) of M3814 After Single Dose | The apparent total body clearance of study intervention following extravascular administration on FD1, taking into account the fraction of dose absorbed. CL/f = Dose oral (p.o.)/AUC0-inf. The predicted AUC0-inf should be used. | Pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Fraction Day 1 and Fraction Day 6 |
| Phase 1a (Arm A and Arm B): Apparent Volume of Distribution (Vz/f) of M3814 After Single Dose | Apparent volume of distribution during the terminal phase following extravascular administration for M8891 was calculated. Vz/f = Dose/(AUC0-infinity multiply by Lambda z) following single dose. The AUC from time zero (dosing time) extrapolated to infinity, based on the predicted value for the concentration at tlast, as estimated using the linear regression from lambda z determination. AUC(0- inf)=AUC0-t plus Clastpred/lambda z where Clastpred was last predicted concentration. Lambda Z was terminal elimination rate constant determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve. | Pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Fraction Day 1 and Fraction Day 6 |
| Phase 1a (Arm A and Arm B): Maximum Plasma Concentration (Cmax) of M3814 After Multiple Dose | Cmax was taken directly from the observed concentration-time curve. | Pre-dose, 0.5, 1, 2 and 4 hours post-dose on Fraction Day 10 |
| Phase 1a (Arm A and Arm B): Time to Reach Maximum Plasma Concentration (Tmax) of M3814 After Multiple Dose | tmax was obtained directly from the concentration versus time curve. | Pre-dose, 0.5, 1, 2 and 4 hours post-dose on Fraction Day 10 |
| Phase 1a (Arm A and Arm B): Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCtau) of M3814 After Multiple Dosing | AUCtau was defined as area under the plasma concentration-time curve from time zero to the end of the dosing interval (tau). AUCtau was calculated using the mixed log linear trapezoidal rule. | Pre-dose, 0.5, 1, 2 and 4 hours post-dose on Fraction Day 10 |
| Phase 1a (Arm A and Arm B): Area Under the Plasma Concentration-Time From Time Zero Extrapolated to Infinity (AUC0-inf) of M3814 After Multiple Dose | The AUC from time zero (dosing time) extrapolated to infinity, based on the predicted value for the concentration at tlast, as estimated using the linear regression from the determination of the terminal first order (elimination) rate constant (lambda z). AUC0-inf = AUC0-t plus Clast pred/lambda z. Lambda z was terminal elimination rate constant determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve. | Pre-dose, 0.5, 1, 2 and 4 hours post-dose on Fraction Day 10 |
| Phase 1a (Arm A and Arm B): Apparent Terminal Half Life (t1/2) of M3814 After Multiple Dose | t1/2 was the time measured for the concentration to decrease by one half. t1/2 was calculated by natural log 2 divided by Lambda z. | Pre-dose, 0.5, 1, 2 and 4 hours post-dose on Fraction Day 10 |
| Phase 1a (Arm A and Arm B): Oral Clearance in Plasma at Steady State (CLss/f) of M3814 After Multiple Dose | Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. | Pre-dose, 0.5, 1, 2 and 4 hours post-dose on Fraction Day 10 |
| Phase 1a (Arm A and Arm B): Apparent Volume of Distribution at Steady-State (Vss/f) of M3814 After Multiple Dose | Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss/f after oral dose was influenced by the fraction absorbed. | Pre-dose, 0.5, 1, 2 and 4 hours post-dose on Fraction Day 10 |
| Phase 1a (Arm A and Arm B): Accumulation Ratio of Area Under the Concentration-Time Curve (AUC) [Racc(AUC0-24)] of M3814 After Multiple Dose | Accumulation ratio for AUC was calculated as AUC, after dosing on fraction Day 10 divided by AUC, after dosing on fraction Day 1 of cycle 1. | Pre-dose, 0.5, 1, 2, 4 and 24 hours post-dose on Fraction Day 1 and Fraction Day 10 |
| Phase 1a (Arm A and Arm B): Accumulation Ratio of Cmax (Racc (Cmax) of M3814 After Multiple Dose | Accumulation ratio for Cmax was calculated as Cmax, after dosing on fraction Day 10 divided by Cmax, after dosing on fraction Day 1 of cycle 1. | Pre-dose, 0.5, 1, 2 and 4 hours post-dose on Fraction Day 1 and Fraction Day 10 |
| Ancillary cPoP: Maximum Observed Plasma Concentration (Cmax) of M3814 | Cmax was taken directly from the observed concentration-time curve. | Pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Fraction Day 2 |
| Ancillary cPoP: Time to Reach Maximum Plasma Concentration (Tmax) of M3814 | tmax was obtained directly from the concentration versus time curve. | Pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Fraction Day 2 |
| Ancillary cPoP: Area Under the Plasma Concentration-time Curve From Time Zero to 4 Hours (AUC0-4) of M3814 | AUC0-4hr is the area under the plasma concentration-time curve from time 0 to 4 hours post-dose. This is a measure of the average amount of study drug M3814 in the blood plasma over a period of 4 hours after the dose. | Pre-dose, 0.5, 1, 2 and 4 hours post-dose on Fraction Day 2 |
| Ancillary cPoP: Area Under the Plasma Concentration-time Curve From Time Zero to Last Sampling Time (Tlast) (AUC0-t) of M3814 | Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. | Pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Fraction Day 2 |
| Ancillary cPoP: Dose Normalized Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t/Dose) of M3814 | AUC0-t/Dose was defined as AUC from time of dosing to the time of the last measurable concentration divided by dose. | Pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Fraction Day 2 |
| Ancillary cPoP: Dose Normalized Area Under the Plasma Concentration-Time Curve From Time Zero to 4 Hours (AUC0-4)/Dose of M3814 | AUC0-4/Dose was defined as AUC from time of dosing to the time zero to 4 hours divided by dose. | Pre-dose, 0.5, 1, 2 and 4 hours post-dose on Fraction Day 2 |
| Ancillary cPoP: Dose Normalized Maximum Observed Plasma Concentration (Cmax/Dose) of M3814 | Cmax/Dose was calculated as maximum observed plasma concentration obtained directly from the concentration versus time curve divided by dose. Cmax/dose was measured in nanogram per milliliter per milligram (ng/mL/mg). | Pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Fraction Day 2 |
| Fort Lauderdale |
| Florida |
| 33308 |
| United States |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
| Research site | Billings | Montana | 59101 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Montefiore Medical Center PRIME | The Bronx | New York | 10461 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Research site | Houston | Texas | 77030 | United States |
| Research site | Tacoma | Washington | 98405 | United States |
| Research site | Leuven | Belgium |
| Rigshospitalet - PARENT | Copenhagen | Denmark |
| Herlev Hospital - PARENT | Herlev | Denmark |
| Research site | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| Charite Research Organisation GmbH - Phase - I Unit of Hematology and Oncology | Berlin | Germany |
| Universitaetsklinikum Carl Gustav Carus TU Dresden | Dresden | Germany |
| Universitaetsklinikum Essen - Westdeutsches Tumorzentrum | Essen | Germany |
| Universitaetsklinikum Heidelberg - RadioOnkologie und Strahlentherapie | Heidelberg | Germany |
| Universitaetsklinikum Schleswig-Holstein - Campus Kiel - Klinik für diagnostische Radiologie | Kiel | Germany |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - Klinik und Poliklinik fuer Radiologie | Mainz | Germany |
| Klinikum Mannheim GmbH Universitaetsklinikum - Parent | Mannheim | Germany |
| Universitaetsklinikum Tuebingen - Medizinische Klinik I | Tübingen | Germany |
| Research site | Amsterdam | 1066 CX | Netherlands |
| Antoni van Leeuwenhoek Ziekenhuis | Amsterdam | Netherlands |
| Research site | Oslo | Norway |
| Karolinska universitetssjukhuset - Solna - Radiumhemmet (onkologi) | Solna | Sweden |
| Universitaetsspital Zuerich - Parent | Zurich | Switzerland |
| FG001 | Phase 1a (Arm A): M3814 Capsule (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| FG002 | Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| FG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| FG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| FG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| FG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| FG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
| FG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
| FG009 | Ancillary cPoP: M3814 Capsule (100 mg) + RT | Participants with at least 2 (sub)cutaneous tumor/metastases of any type (at least 2 centimeters [cm] apart) with an indication for single high dose-palliative RT were included and received single oral dose of M3814 capsule at a dose of 100 mg on Day 2, prior 1.5 hours start of RT and a single high dose of RT (10-25 Gy) on Lesion 1 on Day 1 and on Lesion 2 on Day 2. |
| FG010 | Ancillary cPOP: M3814 Capsule (200 mg) + RT | Participants with at least 2 (sub)cutaneous tumor/metastases of any type (at least 2 cm apart) with an indication for single high dose-palliative RT were included and received single oral dose of M3814 capsule at a dose of 200 mg on Day 2, prior 1.5 hours start of RT and a single high dose of RT (10-25 Gy) on Lesion 1 on Day 1 and on Lesion 2 on Day 2. |
| FG011 | Ancillary cPOP: M3814 Capsule (400 mg) + RT | Participants with at least 2 (sub)cutaneous tumor/metastases of any type (at least 2 cm apart) with an indication for single high dose-palliative RT were included and received single oral dose of M3814 capsule at a dose of 400 mg on Day 2, prior 1.5 hours start of RT and a single high dose of RT (10-25 Gy) on Lesion 1 on Day 1 and on Lesion 2 on Day 2. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1a (Arm A): M3814 Capsule (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative radiotherapy (RT) received 100 milligrams (mg) of M3814 as capsule orally once daily on fraction day (FD) 6 in combination with RT (3 Gray [Gy] x 10, 5 fractions per week [F/W]). |
| BG001 | Phase 1a (Arm A): M3814 Capsule (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| BG002 | Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| BG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| BG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| BG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| BG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| BG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
| BG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
| BG009 | Ancillary cPoP: M3814 Capsule (100 mg) + RT | Participants with at least 2 (sub)cutaneous tumor/metastases of any type (at least 2 centimeters [cm] apart) with an indication for single high dose-palliative RT were included and received single oral dose of M3814 capsule at a dose of 100 mg on Day 2, prior 1.5 hours start of RT and a single high dose of RT (10-25 Gy) on Lesion 1 on Day 1 and on Lesion 2 on Day 2. |
| BG010 | Ancillary cPOP: M3814 Capsule (200 mg) + RT | Participants with at least 2 (sub)cutaneous tumor/metastases of any type (at least 2 cm apart) with an indication for single high dose-palliative RT were included and received single oral dose of M3814 capsule at a dose of 200 mg on Day 2, prior 1.5 hours start of RT and a single high dose of RT (10-25 Gy) on Lesion 1 on Day 1 and on Lesion 2 on Day 2. |
| BG011 | Ancillary cPOP: M3814 Capsule (400 mg) + RT | Participants with at least 2 (sub)cutaneous tumor/metastases of any type (at least 2 cm apart) with an indication for single high dose-palliative RT were included and received single oral dose of M3814 capsule at a dose of 400 mg on Day 2, prior 1.5 hours start of RT and a single high dose of RT (10-25 Gy) on Lesion 1 on Day 1 and on Lesion 2 on Day 2. |
| BG012 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||
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| Primary | Phase 1a (Arm A): Number of Participants Who Experienced at Least One Dose-limiting Toxicity (DLT) According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) | DLT: any Grade (Gr) greater than or equal to (>=) 3 nonhematologic adverse event (AE)/any Gr>=4 hematologic AE that is related to any of study treatments and occurs during the DLT period of 5 weeks (Phase Ia, Arm A) after the first dose of M3814. Following are considered as DLTs: Gr3 thrombocytopenia with medically concerning bleeding; Febrile neutropenia; Any toxicity/study treatment-related adverse event (TEAE) that, in opinion of Safety Monitoring Committee (SMC), is of potential clinical significance such that further dose escalation would expose participants to unacceptable risk; Any toxicity related to study treatments that causes participant to receive less than 80 percent (%) of the planned RT dose; Evidence of study treatment-related hepatocellular injury for > 3 days. | Dose-Escalation Analysis Set included all participants treated in dose-escalation cohorts who received at least 80% of the M3813 and RT planned dose and completed the DLT period (5 weeks after the start of RT) or who experienced a DLT during DLT period regardless of the amount of treatment received. | Posted | Count of Participants | Participants | Time from first dose of study treatment up to 5 weeks |
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| Primary | Phase 1a (Arm B): Number of Participants Who Experienced at Least One Dose-limiting Toxicity (DLT) According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) | DLT: any Grade (Gr) greater than or equal to (>=) 3 nonhematologic AE/any Gr>=4 hematologic AE that is related to any of study treatments and occurs during the DLT period of 12 weeks (Phase Ia, Arm B) after the first dose of M3814. Following are considered as DLTs: Gr3 thrombocytopenia with medically concerning bleeding; Febrile neutropenia; Any toxicity/study treatment-related adverse event (TEAE) that, in opinion of Safety Monitoring Committee (SMC), is of potential clinical significance such that further dose escalation would expose participants to unacceptable risk; Any toxicity related to study treatments that causes participant to receive less than 80 percent (%) of the planned RT dose; Any toxicity related to study treatments leading to an interruption of RT longer than 1 week in Arm B; Evidence of study treatment-related hepatocellular injury for > 3 days. | Dose-Escalation Analysis Set included all participants treated in dose-escalation cohorts who received at least 80% of the M3814 and RT planned dose and completed the DLT period (12 weeks after the start of RT) or who experienced a DLT during DLT period regardless of the amount of treatment received. | Posted | Count of Participants | Participants | Time from first dose of study treatment up to 12 weeks |
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| Secondary | Phase 1a (Arm A and Arm B): Number of Participants With Grade Greater Than or Equal to (>=) 3 Treatment-Emergent Adverse Events (TEAEs) According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) | Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily have a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious AEs and non-serious AEs. As per NCI-CTCAE v4.03, Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death. Number of participants with Grade >=3 TEAEs were reported. | Safety analysis set included all participants who received at >= 1 administration of study intervention (either M3814 or RT). | Posted | Count of Participants | Participants | Time from first dose of study treatment up to long term safety follow-up period (Up to approximately 1 year) |
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| Secondary | Phase 1a (Arm A and Arm B): Number of Participants With Shifts From Baseline to Worst Post-Baseline Grade in Hematology Parameters According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTC v4.03) | Number of participants with shifts from Baseline values (Grade 0/1/2) to worst post-baseline values (Grade 1/2/3/4) were reported as per NCI-CTCAE, v4.03 graded from Grade 1 to 5. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death. Shifts in hematology parameter (hemoglobin low, leukocytes low, lymphocytes low, neutrophil count decreased, and platelet count decreased) were reported. | Safety analysis set included all participants who received at >= 1 administration of study intervention (either M3814 or RT). | Posted | Count of Participants | Participants | Time from first dose of study treatment up to long term safety follow-up period (Up to approximately 1 year) |
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| Secondary | Phase 1a (Arm A and Arm B): Number of Participants With Shifts From Baseline to Worst Post-Baseline Grade in Biochemistry Parameters According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) | Number of participants with shifts from Baseline values (Grade 0/1/2) to worst post-baseline values (Grade 1/2/3/4) were reported as per NCI-CTCAE, v4.03 graded from Grade 1 to 5. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death. Shifts in biochemistry parameter (phosphate low, potassium low, sodium low, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, blood bilirubin increased, glucose high, glucose low, albumin low and creatinine increased) were reported. | Safety analysis set included all participants who received at >= 1 administration of study intervention (either M3814 or RT). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Time from first dose of study treatment up to long term safety follow-up period (Up to approximately 1 year) |
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| Secondary | Phase 1a (Arm A and Arm B): Number of Participants With Markedly Abnormal Vital Sign Measurements | Vital sign assessments included assessments of heart rate, blood pressure, body weight and body temperature. Abnormal vital sign measurement was decided by Investigator. Number of participants with markedly abnormal vital sign measurements were reported. | Safety analysis set included all participants who received at >= 1 administration of study intervention (either M3814 or RT). | Posted | Count of Participants | Participants | Time from first dose of study treatment up to long term safety follow-up period (Up to approximately 1 year) |
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| Secondary | Phase 1a (Arm A and Arm B): Number of Participants With Shifts From Normal Baseline to Abnormal Post-baseline in Electrocardiogram (ECG) | Electrocardiograms (ECG) was obtained after the participant has been in a supine position for at least 5 minutes. ECG parameters included heart rate, atrial ventricular conduction, QR and QT intervals (including QTcF), and possible arrhythmias. Any ECG finding that was judged by the investigator as a abnormal (worsening) compared with a baseline value was considered an adverse event. Number of participants with shifts from normal baseline values to abnormal post-baseline values in ECG were reported. | Safety analysis set included all participants who received at >= 1 administration of study intervention (either M3814 or RT). | Posted | Count of Participants | Participants | Time from first dose of study treatment up to long term safety follow-up period (Up to approximately 1 year) |
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| Secondary | Phase 1a (Arm A and Arm B): Number of Participants With Confirmed Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator | Confirmed BOR was defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. CR or PR must be confirmed by a subsequent tumor assessment, at least 4 weeks after initial documentation of CR or PR. | Full analysis set included all participants who received at >= 1 administration of study intervention (either M3814 or RT). | Posted | Count of Participants | Participants | Time from first dose of study treatment up to long term safety follow-up period (Up to approximately 1 year) |
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| Secondary | Phase 1a (Arm A and Arm B): Number of Participants With Unconfirmed Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator | Unconfirmed BOR was defined as unconfirmed best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | Full analysis set included all participants who received at >= 1 administration of study intervention (either M3814 or RT). | Posted | Count of Participants | Participants | Time from first dose of study treatment up to long term safety follow-up period (Up to approximately 1 year) |
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| Secondary | Phase 1a (Arm A and Arm B): Median Percent Change From Baseline in Tumor Size Measurement According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator | The tumor size was defined as the sum of the longest diameters for the target lesions. The sum of lesion diameters was calculated using RECIST v1.1 and was assessed by Investigator. | Full analysis set included all participants who received at >= 1 administration of study intervention (either M3814 or RT). | Posted | Median | Full Range | percentage change | Time from first dose of study treatment up to long term safety follow-up period (Up to approximately 1 year) |
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| Secondary | Phase 1a (Arm A and Arm B): Maximum Plasma Concentration (Cmax) of M3814 After Single Dose | Cmax was taken directly from the observed concentration-time curve. | Pharmacokinetic analysis set: all participants who received at least the first dose of the treatment (either M3814 or RT) and provided >= 3 valid post-dose concentration points within 6 hours (0-6 hours inclusive). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and number analyzed= participants evaluable at specified timepoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Fraction Day 1 and Fraction Day 6 |
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| Secondary | Phase 1a (Arm A and Arm B): Time to Reach Maximum Plasma Concentration (Tmax) of M3814 After Single Dose | tmax was obtained directly from the concentration versus time curve. | Pharmacokinetic analysis set included all participants who received at least the first dose of the treatment (either M3814 or RT) and provided >= 3 valid post-dose concentration points within 6 hours (0-6 hours inclusive). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed"= participants evaluable at specified timepoints. | Posted | Median | Full Range | hours | Pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Fraction Day 1 and Fraction Day 6 |
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| Secondary | Phase 1a (Arm A and Arm B): Area Under the Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24) of M3814 After Single Dose | AUC0-24 of M3814 was defined as the area under the concentration time curve from time 0 to 24 hours post-dose. | Pharmacokinetic analysis set included all participants who received at least the first dose of the treatment (either M3814 or RT) and provided >= 3 valid post-dose concentration points within 6 hours (0-6 hours inclusive). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed"= participants evaluable at specified timepoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliliter (h*ng/mL) | Pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post-dose on Fraction Day 1 and Fraction Day 6 |
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| Secondary | Phase 1a (Arm A and Arm B): Area Under the Plasma Concentration-Time From Time Zero Extrapolated to Infinity (AUC0-inf) of M3814 After Single Dose | The AUC from time zero (dosing time) extrapolated to infinity, based on the predicted value for the concentration at tlast, as estimated using the linear regression from the determination of the terminal first order (elimination) rate constant (lambda z). AUC0-inf = AUC0-t plus Clast pred/lambda z. Lambda z was terminal elimination rate constant determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve. | Pharmacokinetic analysis set included all participants who received at least the first dose of the treatment (either M3814 or RT) and provided >= 3 valid post-dose concentration points within 6 hours (0-6 hours inclusive). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed"= participants evaluable at specified timepoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Fraction Day 1 and Fraction Day 6 |
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| Secondary | Phase 1a (Arm A and Arm B): Apparent Terminal Half Life (t1/2) of M3814 After Single Dose | t1/2 was the time measured for the concentration to decrease by one half. t1/2 was calculated by natural log 2 divided by Lambda z. | Pharmacokinetic analysis set included all participants who received at least the first dose of the treatment (either M3814 or RT) and provided >= 3 valid post-dose concentration points within 6 hours (0-6 hours inclusive). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed"= participants evaluable at specified timepoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Fraction Day 1 and Fraction Day 6 |
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| Secondary | Phase 1a (Arm A and Arm B): Total Body Clearance Following Oral Administration (CL/f) of M3814 After Single Dose | The apparent total body clearance of study intervention following extravascular administration on FD1, taking into account the fraction of dose absorbed. CL/f = Dose oral (p.o.)/AUC0-inf. The predicted AUC0-inf should be used. | Pharmacokinetic analysis set included all participants who received at least the first dose of the treatment (either M3814 or RT) and provided >= 3 valid post-dose concentration points within 6 hours (0-6 hours inclusive). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed"= participants evaluable at specified timepoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter per hour | Pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Fraction Day 1 and Fraction Day 6 |
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| Secondary | Phase 1a (Arm A and Arm B): Apparent Volume of Distribution (Vz/f) of M3814 After Single Dose | Apparent volume of distribution during the terminal phase following extravascular administration for M8891 was calculated. Vz/f = Dose/(AUC0-infinity multiply by Lambda z) following single dose. The AUC from time zero (dosing time) extrapolated to infinity, based on the predicted value for the concentration at tlast, as estimated using the linear regression from lambda z determination. AUC(0- inf)=AUC0-t plus Clastpred/lambda z where Clastpred was last predicted concentration. Lambda Z was terminal elimination rate constant determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve. | Pharmacokinetic analysis set included all participants who received at least the first dose of the treatment (either M3814 or RT) and provided >= 3 valid post-dose concentration points within 6 hours (0-6 hours inclusive). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed"= participants evaluable at specified timepoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters | Pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Fraction Day 1 and Fraction Day 6 |
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| Secondary | Phase 1a (Arm A and Arm B): Maximum Plasma Concentration (Cmax) of M3814 After Multiple Dose | Cmax was taken directly from the observed concentration-time curve. | Pharmacokinetic analysis set: all participants who received at least the first dose of the treatment (either M3814 or RT) and provided >= 3 valid post-dose concentration points within 6 hours (0-6 hours inclusive). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 0.5, 1, 2 and 4 hours post-dose on Fraction Day 10 |
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| Secondary | Phase 1a (Arm A and Arm B): Time to Reach Maximum Plasma Concentration (Tmax) of M3814 After Multiple Dose | tmax was obtained directly from the concentration versus time curve. | Pharmacokinetic analysis set: all participants who received at least the first dose of the treatment (either M3814 or RT) and provided >= 3 valid post-dose concentration points within 6 hours (0-6 hours inclusive). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Median | Full Range | hours | Pre-dose, 0.5, 1, 2 and 4 hours post-dose on Fraction Day 10 |
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| Secondary | Phase 1a (Arm A and Arm B): Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCtau) of M3814 After Multiple Dosing | AUCtau was defined as area under the plasma concentration-time curve from time zero to the end of the dosing interval (tau). AUCtau was calculated using the mixed log linear trapezoidal rule. | As per changes in planned analysis, the pharmacokinetic parameters (AUCtau) was not assessed. | Posted | Pre-dose, 0.5, 1, 2 and 4 hours post-dose on Fraction Day 10 |
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| Secondary | Phase 1a (Arm A and Arm B): Area Under the Plasma Concentration-Time From Time Zero Extrapolated to Infinity (AUC0-inf) of M3814 After Multiple Dose | The AUC from time zero (dosing time) extrapolated to infinity, based on the predicted value for the concentration at tlast, as estimated using the linear regression from the determination of the terminal first order (elimination) rate constant (lambda z). AUC0-inf = AUC0-t plus Clast pred/lambda z. Lambda z was terminal elimination rate constant determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve. | PK Analysis Set has been used here. The AUC-inf for peposertib cannot be calculated accurately when the sampling scheme is limited to 0-4 hours and the tmax ranges from 1 to 4 hours especially considering a half-life of 6 hours. Since the sampling scheme only covers 0-4 hours, the terminal elimination phase is not captured. As a result, it was not possible to calculate data for AUC0-inf because dosing interval was too small to have reliable results. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Pre-dose, 0.5, 1, 2 and 4 hours post-dose on Fraction Day 10 |
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| Secondary | Phase 1a (Arm A and Arm B): Apparent Terminal Half Life (t1/2) of M3814 After Multiple Dose | t1/2 was the time measured for the concentration to decrease by one half. t1/2 was calculated by natural log 2 divided by Lambda z. | Pharmacokinetic analysis set included all participants who received at least the first dose of the treatment (either M3814 or RT) and provided >= 3 valid post-dose concentration points within 6 hours (0-6 hours inclusive). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed"= participants evaluable for this outcome measure at specified timepoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Pre-dose, 0.5, 1, 2 and 4 hours post-dose on Fraction Day 10 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Phase 1a (Arm A and Arm B): Oral Clearance in Plasma at Steady State (CLss/f) of M3814 After Multiple Dose | Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. | As per changes in planned analysis, the pharmacokinetic parameters (Clss/f) was not assessed. | Posted | Pre-dose, 0.5, 1, 2 and 4 hours post-dose on Fraction Day 10 |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Phase 1a (Arm A and Arm B): Apparent Volume of Distribution at Steady-State (Vss/f) of M3814 After Multiple Dose | Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss/f after oral dose was influenced by the fraction absorbed. | As per changes in planned analysis, the pharmacokinetic parameters (Vss/f) was not assessed. | Posted | Pre-dose, 0.5, 1, 2 and 4 hours post-dose on Fraction Day 10 |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Phase 1a (Arm A and Arm B): Accumulation Ratio of Area Under the Concentration-Time Curve (AUC) [Racc(AUC0-24)] of M3814 After Multiple Dose | Accumulation ratio for AUC was calculated as AUC, after dosing on fraction Day 10 divided by AUC, after dosing on fraction Day 1 of cycle 1. | Pharmacokinetic analysis set included all participants who received at least the first dose of the treatment (either M3814 or RT) and provided >= 3 valid post-dose concentration points within 6 hours (0-6 hours inclusive). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | Pre-dose, 0.5, 1, 2, 4 and 24 hours post-dose on Fraction Day 1 and Fraction Day 10 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Phase 1a (Arm A and Arm B): Accumulation Ratio of Cmax (Racc (Cmax) of M3814 After Multiple Dose | Accumulation ratio for Cmax was calculated as Cmax, after dosing on fraction Day 10 divided by Cmax, after dosing on fraction Day 1 of cycle 1. | Pharmacokinetic analysis set included all participants who received at least the first dose of the treatment (either M3814 or RT) and provided >= 3 valid post-dose concentration points within 6 hours (0-6 hours inclusive). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | Pre-dose, 0.5, 1, 2 and 4 hours post-dose on Fraction Day 1 and Fraction Day 10 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Ancillary cPoP: Maximum Observed Plasma Concentration (Cmax) of M3814 | Cmax was taken directly from the observed concentration-time curve. | Pharmacokinetic analysis set: all participants who received at least the first dose of the treatment (either M3814 or RT) and provided >= 3 valid post-dose concentration points within 6 hours (0-6 hours inclusive). | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Fraction Day 2 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Ancillary cPoP: Time to Reach Maximum Plasma Concentration (Tmax) of M3814 | tmax was obtained directly from the concentration versus time curve. | Pharmacokinetic analysis set: all participants who received at least the first dose of the treatment (either M3814 or RT) and provided >= 3 valid post-dose concentration points within 6 hours (0-6 hours inclusive). | Posted | Median | Full Range | hours | Pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Fraction Day 2 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Ancillary cPoP: Area Under the Plasma Concentration-time Curve From Time Zero to 4 Hours (AUC0-4) of M3814 | AUC0-4hr is the area under the plasma concentration-time curve from time 0 to 4 hours post-dose. This is a measure of the average amount of study drug M3814 in the blood plasma over a period of 4 hours after the dose. | Pharmacokinetic analysis set: all participants who received at least the first dose of the treatment (either M3814 or RT) and provided >= 3 valid post-dose concentration points within 6 hours (0-6 hours inclusive). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Median | Full Range | h*ng/mL | Pre-dose, 0.5, 1, 2 and 4 hours post-dose on Fraction Day 2 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Ancillary cPoP: Area Under the Plasma Concentration-time Curve From Time Zero to Last Sampling Time (Tlast) (AUC0-t) of M3814 | Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. | Pharmacokinetic analysis set: all participants who received at least the first dose of the treatment (either M3814 or RT) and provided >= 3 valid post-dose concentration points within 6 hours (0-6 hours inclusive). | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Fraction Day 2 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Ancillary cPoP: Dose Normalized Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t/Dose) of M3814 | AUC0-t/Dose was defined as AUC from time of dosing to the time of the last measurable concentration divided by dose. | Pharmacokinetic analysis set: all participants who received at least the first dose of the treatment (either M3814 or RT) and provided >= 3 valid post-dose concentration points within 6 hours (0-6 hours inclusive). | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL/mg | Pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Fraction Day 2 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Ancillary cPoP: Dose Normalized Area Under the Plasma Concentration-Time Curve From Time Zero to 4 Hours (AUC0-4)/Dose of M3814 | AUC0-4/Dose was defined as AUC from time of dosing to the time zero to 4 hours divided by dose. | Pharmacokinetic analysis set: all participants who received at least the first dose of the treatment (either M3814 or RT) and provided >= 3 valid post-dose concentration points within 6 hours (0-6 hours inclusive). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL/mg | Pre-dose, 0.5, 1, 2 and 4 hours post-dose on Fraction Day 2 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Ancillary cPoP: Dose Normalized Maximum Observed Plasma Concentration (Cmax/Dose) of M3814 | Cmax/Dose was calculated as maximum observed plasma concentration obtained directly from the concentration versus time curve divided by dose. Cmax/dose was measured in nanogram per milliliter per milligram (ng/mL/mg). | Pharmacokinetic analysis set: all participants who received at least the first dose of the treatment (either M3814 or RT) and provided >= 3 valid post-dose concentration points within 6 hours (0-6 hours inclusive). | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL/mg | Pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Fraction Day 2 |
|
Time from first dose of study treatment up to long term safety follow-up period (Up to approximately 1 year)
For Phase 1a (Arm A and Arm B): MedDRA Version 23.1 and for Ancillary clinical proof-of-principle (cPoP): MedDRA Version 22.1
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1a (Arm A): M3814 Capsule (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative radiotherapy (RT) received 100 milligrams (mg) of M3814 as capsule orally once daily on fraction day (FD) 6 in combination with RT (3 Gray [Gy] x 10, 5 fractions per week [F/W]). | 4 | 7 | 1 | 7 | 7 | 7 |
| EG001 | Phase 1a (Arm A): M3814 Capsule (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). | 2 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). | 2 | 3 | 2 | 3 | 2 | 3 |
| EG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). | 6 | 6 | 2 | 6 | 6 | 6 |
| EG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). | 3 | 6 | 1 | 6 | 6 | 6 |
| EG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). | 2 | 3 | 0 | 3 | 3 | 3 |
| EG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). | 3 | 6 | 3 | 6 | 6 | 6 |
| EG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). | 1 | 8 | 2 | 8 | 8 | 8 |
| EG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). | 1 | 3 | 1 | 3 | 3 | 3 |
| EG009 | Ancillary cPoP: M3814 Capsule (100 mg) + RT | Participants with at least 2 (sub)cutaneous tumor/metastases of any type (at least 2 centimeters [cm] apart) with an indication for single high dose-palliative RT were included and received single oral dose of M3814 capsule at a dose of 100 mg on Day 2, prior 1.5 hours start of RT and a single high dose of RT (10-25 Gy) on Lesion 1 on Day 1 and on Lesion 2 on Day 2. | 0 | 3 | 1 | 3 | 2 | 3 |
| EG010 | Ancillary cPOP: M3814 Capsule (200 mg) + RT | Participants with at least 2 (sub)cutaneous tumor/metastases of any type (at least 2 cm apart) with an indication for single high dose-palliative RT were included and received single oral dose of M3814 capsule at a dose of 200 mg on Day 2, prior 1.5 hours start of RT and a single high dose of RT (10-25 Gy) on Lesion 1 on Day 1 and on Lesion 2 on Day 2. | 0 | 3 | 1 | 3 | 3 | 3 |
| EG011 | Ancillary cPOP: M3814 Capsule (400 mg) + RT | Participants with at least 2 (sub)cutaneous tumor/metastases of any type (at least 2 cm apart) with an indication for single high dose-palliative RT were included and received single oral dose of M3814 capsule at a dose of 400 mg on Day 2, prior 1.5 hours start of RT and a single high dose of RT (10-25 Gy) on Lesion 1 on Day 1 and on Lesion 2 on Day 2. | 0 | 1 | 0 | 1 | 0 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Muscle abscess | Infections and infestations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Radiation associated pain | Injury, poisoning and procedural complications | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Ureteric stenosis | Renal and urinary disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Anaemia of chronic disease | Blood and lymphatic system disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Anaemia of malignant disease | Blood and lymphatic system disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Ear haemorrhage | Ear and labyrinth disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Lip erythema | Gastrointestinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Salivary duct inflammation | Gastrointestinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Swollen tongue | Gastrointestinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Tongue movement disturbance | Gastrointestinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Application site haemorrhage | General disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Facial pain | General disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Mucosal infection | Infections and infestations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Radiation dysphagia | Injury, poisoning and procedural complications | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Radiation mucositis | Injury, poisoning and procedural complications | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Radiation oesophagitis | Injury, poisoning and procedural complications | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increase | Investigations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Troponin T increased | Investigations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Hair growth abnormal | Skin and subcutaneous tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Skin induration | Skin and subcutaneous tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Ophthalmoplegia | Eye disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Secretion discharge | General disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Vessel puncture site erythema | General disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Oral infection | Infections and infestations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Aphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Vascular pain | Vascular disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA v23.1,22.1 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@emdgroup.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 18, 2020 | Nov 20, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000716216 | peposertib |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG001 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
|
|
| OG001 | Phase 1a (Arm A): M3814 Capsule (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG002 | Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
| OG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
|
|
Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG002 | Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
| OG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
|
|
| OG001 | Phase 1a (Arm A): M3814 Capsule (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG002 | Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
| OG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
|
|
| OG002 | Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
| OG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
|
|
Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W).
| OG002 | Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
| OG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
|
|
| OG001 | Phase 1a (Arm A): M3814 Capsule (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG002 | Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
| OG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
|
|
| OG001 |
| Phase 1a (Arm A): M3814 Capsule (200 mg) + RT |
Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG002 | Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
| OG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
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| OG002 | Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
| OG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
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| OG002 | Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
| OG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
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| OG002 | Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
| OG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
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| OG002 | Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
| OG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
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| OG001 | Phase 1a (Arm A): M3814 Capsule (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG002 | Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
| OG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
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| OG002 | Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
| OG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
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Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W).
| OG002 | Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
| OG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
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| OG001 | Phase 1a (Arm A): M3814 Capsule (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG002 | Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
| OG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
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| OG002 | Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
| OG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
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| OG002 | Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
| OG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
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| OG002 | Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
| OG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
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| OG001 | Phase 1a (Arm A): M3814 Capsule (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG002 | Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
| OG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
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| OG002 | Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
| OG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
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| Phase 1a (Arm A): M3814 Capsule (300 mg) + RT |
Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
| OG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
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| OG002 | Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
| OG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
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| OG002 | Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
| OG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
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| OG002 | Phase 1a (Arm A): M3814 Capsule (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG003 | Phase 1a (Arm A): M3814 Capsule (400 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 400 mg of M3814 as capsule orally once daily on FD 6 in combination with RT (3 [Gy] x 10, 5 F/W). |
| OG004 | Phase 1a (Arm A): M3814 Tablet (100 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 100 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG005 | Phase 1a (Arm A): M3814 Tablet (200 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 200 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG006 | Phase 1a (Arm A): M3814 Tablet (300 mg) + RT | Participants with locally advanced disease (any tumor or metastases including lymphomas) localized in the head and neck region or thorax that was not amenable to surgical therapy, or with standard systemic therapy with an indication for palliative RT received 300 mg of M3814 as tablet orally once daily for 2 consecutive weeks in combination with RT (3 Gy x 10, 5 F/W). |
| OG007 | Phase 1a (Arm B): M3814 Capsule (50 mg) + CRT | Participants with local/locally advanced squamous cell carcinoma of the head and neck (SCCHN) received 50 mg of M3814 as capsule orally once daily on FD 6 in combination with fractionated RT (2 Gy x 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 milligrams per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2). |
| OG008 | Phase 1a (Arm B): M3814 Tablet (100 mg) + CRT | Participants with squamous cell carcinoma of the head and neck (SCCHN) received 100 mg of M3814 as tablet orally once daily for 7 consecutive weeks in combination with fractionated RT (2 Gy X 33 to 35 fractions; 5 F/W) and Cisplatin twice at a dose of 100 mg/m^2 or weekly at a dose of 40 (mg/m^2). |
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| Ancillary cPOP: M3814 Capsule (400 mg) + RT |
Participants with at least 2 (sub)cutaneous tumor/metastases of any type (at least 2 cm apart) with an indication for single high dose-palliative RT were included and received single oral dose of M3814 capsule at a dose of 400 mg on Day 2, prior 1.5 hours start of RT and a single high dose of RT (10-25 Gy) on Lesion 1 on Day 1 and on Lesion 2 on Day 2. |
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| Ancillary cPOP: M3814 Capsule (400 mg) + RT |
Participants with at least 2 (sub) cutaneous tumor/metastases of any type (at least 2 cm apart) with an indication for single high dose-palliative RT were included and received single oral dose of M3814 capsule at a dose of 400 mg on Day 2, prior 1.5 hours start of RT and a single high dose of RT (10-25 Gy) on Lesion 1 on Day 1 and on Lesion 2 on Day 2. |
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| OG002 | Ancillary cPOP: M3814 Capsule (400 mg) + RT | Participants with at least 2 (sub) cutaneous tumor/metastases of any type (at least 2 cm apart) with an indication for single high dose-palliative RT were included and received single oral dose of M3814 capsule at a dose of 400 mg on Day 2, prior 1.5 hours start of RT and a single high dose of RT (10-25 Gy) on Lesion 1 on Day 1 and on Lesion 2 on Day 2. |
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| OG002 | Ancillary cPOP: M3814 Capsule (400 mg) + RT | Participants with at least 2 (sub)cutaneous tumor/metastases of any type (at least 2 cm apart) with an indication for single high dose-palliative RT were included and received single oral dose of M3814 capsule at a dose of 400 mg on Day 2, prior 1.5 hours start of RT and a single high dose of RT (10-25 Gy) on Lesion 1 on Day 1 and on Lesion 2 on Day 2. |
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| OG002 | Ancillary cPOP: M3814 Capsule (400 mg) + RT | Participants with at least 2 (sub)cutaneous tumor/metastases of any type (at least 2 cm apart) with an indication for single high dose-palliative RT were included and received single oral dose of M3814 capsule at a dose of 400 mg on Day 2, prior 1.5 hours start of RT and a single high dose of RT (10-25 Gy) on Lesion 1 on Day 1 and on Lesion 2 on Day 2. |
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| OG002 | Ancillary cPOP: M3814 Capsule (400 mg) + RT | Participants with at least 2 (sub) cutaneous tumor/metastases of any type (at least 2 cm apart) with an indication for single high dose-palliative RT were included and received single oral dose of M3814 capsule at a dose of 400 mg on Day 2, prior 1.5 hours start of RT and a single high dose of RT (10-25 Gy) on Lesion 1 on Day 1 and on Lesion 2 on Day 2. |
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| OG002 | Ancillary cPOP: M3814 Capsule (400 mg) + RT | Participants with at least 2 (sub)cutaneous tumor/metastases of any type (at least 2 cm apart) with an indication for single high dose-palliative RT were included and received single oral dose of M3814 capsule at a dose of 400 mg on Day 2, prior 1.5 hours start of RT and a single high dose of RT (10-25 Gy) on Lesion 1 on Day 1 and on Lesion 2 on Day 2. |
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