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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002275-18 | EudraCT Number |
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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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The main purpose of the study was to define maximum tolerated dose (MTD), recommended Phase II dose (RP2D) safety and tolerability of Peposertib in combination with capecitabine and radiotherapy (RT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peposertib 50 mg + RT + Capecitabine | Experimental | Participants received peposertib 50 milligram (mg) once daily in combination with capecitabine 825 milligram per square meter (mg/m^2) twice daily 5 days per week and radiotherapy (RT) of 50 to 50.4 Gray (Gy) to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
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| Peposertib 100 mg + RT + Capecitabine | Experimental | Participants received peposertib 100 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
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| Peposertib 150 mg + RT + Capecitabine | Experimental | Participants received peposertib 150 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
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| Peposertib 250 mg + RT + Capecitabine | Experimental | Participants received peposertib 250 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peposertib 50 mg | Drug | Participants received peposertib 50 milligram (mg) once daily 5 days per week up to 5.5 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Dose Limiting Toxicity (DLT) Confirmed by Safety Monitoring Committee (SMC) | DLT is defined as any of following treatment emergent adverse events (TEAEs) considered possibly related to study treatment by Investigator and/or Sponsor up to completion of assigned chemoradiotherapy treatment. DLT were based on SMC: Adverse drug reaction that, in the opinion of SMC, is of potential clinical significance such that further dose escalation would expose participants to unacceptable risk; Any occurrence of drug-induced liver injury meeting the Hy's law criteria; Any Grade 3 toxicity excluding diarrhea, neutropenia lasting for ≤ 5 days, nausea & vomiting, Grade 3 thrombocytopenia without bleeding; Grade ≥ 4 AEs at least possibly related to study drug, irrespective of duration, excluding: Isolated Grade 4 lymphocytopenia without clinical symptoms; Neutropenia lasting for ≤ 5 days and not associated with fever; Any toxicity related to study drug that causes participant to receive > 80% of planned peposertib, capecitabine or RT dose. | Time from first study intervention up to 19 weeks (including 5.5 weeks of treatment and 13.5 weeks of short term safety follow-up period) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Wtih Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs According to National Cancer Institute Common Terminology Criteria of Adverse Events (NCI-CTCAE) Version 5.0 | Adverse event (AE) is any untoward medical occurrence in participant administered pharmaceutical product, regardless of causal relationship with this treatment. Therefore, an AE can be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless if it is considered related to medicinal product. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after treatment start date. TEAEs included both serious and non-serious TEAEs. Treatment-related TEAEs: reasonably related to study intervention. Number of participants with TEAEs and treatment related TEAEs were reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | United States | ||
| Yale University - Pediatric Respiratory Medicine |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| US Medical Information website, Medical Resources | View source |
| DDRiver website |
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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 two phases: Phase Ib and Phase II. Phase II of the study was never initiated due to early discontinuation as per sponsor's decision.
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| ID | Title | Description |
|---|---|---|
| FG000 | Peposertib 50 mg + RT + Capecitabine: | Participants received peposertib 50 milligram (mg) once daily in combination with capecitabine 825 milligram per square meter (mg/m^2) twice daily 5 days per week and radiotherapy (RT) of 50 to 50.4 Gray (Gy) to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
| 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 | May 6, 2021 | Jun 9, 2022 |
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| Peposertib 100 mg | Drug | Participants received peposertib 100 mg once daily 5 days per week up to 5.5 weeks. |
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| Peposertib 150 mg | Drug | Participants received peposertib 150 mg once daily 5 days per week up to 5.5 weeks. |
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| Peposertib 250 mg | Drug | Participants received peposertib 250 mg once daily 5 days per week up to 5.5 weeks. |
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| Capecitabine | Drug | Participants received capecitabine at a dose of 825 milligram per square meter (mg/m^2) twice daily 5 days per week up to 5.5 weeks. |
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| Radiotherapy (RT) | Radiation | Participants received RT 50 to 50.4 Gray (Gy) to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks. |
|
| Time from first study intervention up to long term safety follow-up period (Up to Month 35) |
| Number of Participants With Abnormalities [Grade Greater Than or Equals to (>=) 3] in Laboratory Test Values | The laboratory measurements included hematology and biochemistry values were graded with National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 toxicity grades (where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening and Grade 5 = death). Number of participants with abnormalities Grade >= 3 in laboratory test values were reported. | Time from first study intervention up to long term safety follow-up period (Up to Month 35) |
| Number of Participants With Markedly Abnormal Vital Sign Measurements | Vital sign assessments included assessments of heart rate, diastolic blood pressure, systolic blood pressure, respiratory rate and temperature. Number of participants with markedly abnormal vital sign measurements were reported. | Time from first study intervention up to long term safety follow-up period (Up to Month 35) |
| Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings | Electrocardiograms (ECG) was obtained after the participant has been in a semi-supine position for at least 5 min. ECG parameters included heart rate, PQ/PR duration, QRS and QT duration, QT Interval. Clinical significance was determined by the investigator. Number of participants with clinically significant abnormalities in 12-lead ECG were reported. | Time from first study intervention up to long term safety follow-up period (Up to Month 35) |
| Percentage of Participants With Composite Pathological Complete Response (pCR)/ Clinical Complete Response (cCR) | pCR: It is defined as absence of viable tumor cells in the primary tumor and lymph nodes. Participants considered to have a pCR if they undergo surgery and no residual cancer is found on histological examination of removed specimen. cCR: Participants are considered to have a cCR if: 1) Absence of any residual tumor in primary site and draining lymph nodes on imaging with magnetic resonance imaging; 2) No visible lesion at endoscopy except a flat scar, telangiectasia, and/or whitening of mucosa; 3) Absence of any palpable tumor or irregularity on digital rectal examination (DRE) and endoscopic ultrasonography (EUS); 4) If a biopsy is taken, it must be negative. Participants are considered as responders to composite endpoint pCR/cCR if participant had surgery and had pCR; participant did not undergo surgery but had cCR. Number of participants with composite pathological complete response (pCR)/ clinical complete response (cCR) were reported. | At Week 15 |
| Disease-free Survival | Disease-free Survival time, defined as the time from first treatment day to the date of the first documentation of objective progressive disease or death due to any cause, whichever occurs first. Median disease-free survival time was estimated according to Kaplan-Meier method. | Time from first study intervention up to approximately 35 months |
| Percentage of Participants With Pathological Complete Response (pCR) | pCR is defined as the absence of viable tumor cells in the primary tumor and lymph nodes. Participants are considered to have a pCR if they undergo surgery and no residual cancer is found on histological examination of the removed specimen. | At Week 15 |
| Percentage of Participants With Clinical Complete Response (cCR) | cCR: It is defined as participants considered to have a cCR if: 1) Absence of any residual tumor in the primary site and draining lymph nodes on imaging with magnetic resonance; 2) No visible lesion at endoscopy except a flat scar, telangiectasia, and/or whitening of the mucosa; 3) Absence of any palpable tumor or irregularity on digital rectal examination (DRE) and endoscopic ultrasonography (EUS); 4) If a biopsy is taken, it must be negative. | At Week 15 |
| Time From Surgery to Local Recurrence | Time from surgery to local recurrence defined as time from day of surgery to the date of the first documentation of progression of disease, flagged as local recurrence. Median time from surgery to local recurrence was estimated according to Kaplan-Meier method. | Time from surgery up to 15 months |
| Time From Surgery to Distant Metastasis | Time from surgery to distant metastasis defined as time from day of surgery to the date of the first documentation of progression of disease, flagged as distant metastasis. Median time from surgery to distant metastasis was estimated according to Kaplan-Meier method. | Time from surgery up to 15 months |
| Neoadjuvant Rectal (NAR) Score | The NAR formula includes the clinical tumor (cT) stage, pathologic tumor (pT), and node (pN) stage according to the tumor, node, metastasis classification system for colorectal cancers. The NAR formula is as follows: [5pN- 3 (cT- pT) + 12]2 / 9.61 NAR score ranges from 0 to 100, whereas a score close to 100 is indicative of a poorer prognosis. | At Week 15 |
| Maximum Observed Plasma Concentration (Cmax) of Peposertib | Cmax was obtained directly from the concentration versus time curve. One participant was assigned to receive peposertib 100 mg; however, this participant took peposertib 50 mg for FD 1 through FD 10 and then took peposertib 100 mg for remainder of study participation. PK results for this participant was summarized by actual dose received (50 mg) whereas non-PK results are summarized by planned dose (100 mg). | Pre-dose, 1, 2, 3, 4 and 6 hours post-dose on Fraction Day 1 and Fraction Day 9 |
| Area Under the Plasma Concentration-time Curve From Time Zero to Last Sampling Time (Tlast) (AUC0-t) of Peposertib | 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 (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. | Pre-dose, 1, 2, 3, 4 and 6 hour post-dose on Fraction Day 1 and Fraction Day 9 |
| Time to Reach Maximum Plasma Concentration (Tmax) of Peposertib | Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve. | Pre-dose, 1, 2, 3, 4 and 6 hour post-dose on Fraction Day 1 and Fraction Day 9 |
| Total Body Clearance Following Oral Administration (CL/f) of Peposertib | 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, 1, 2, 3, 4 and 6 hour post-dose on Fraction Day 1 |
| Apparent Volume of Distribution (Vz/f) of Peposertib | The apparent volume of distribution during the terminal phase following extravascular administration, based on the fraction of dose absorbed. Vz/f = Dose/(AUC0-inf multiplied by Lambda z) following single dose. Vz/f= Dose/(AUCtau*Lambda z) following multiple dose. One participant was assigned to receive peposertib 100 mg; however, this participant took peposertib 50 mg for FD 1 through FD 10 and then took peposertib 100 mg for remainder of study participation. PK results for this participant was summarized by actual dose received (50 mg) whereas non-PK results are summarized by planned dose (100 mg). | Pre-dose, 1, 2, 3, 4 and 6 hour post-dose on Fraction Day 1 and Fraction Day 9 |
| Apparent Terminal Half-life (t1/2) of Peposertib | Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by lambda z. One participant was assigned to receive peposertib 100 mg; however, this participant took peposertib 50 mg for FD 1 through FD 10 and then took peposertib 100 mg for remainder of study participation. PK results for this participant was summarized by actual dose received (50 mg) whereas non-PK results are summarized by planned dose (100 mg). | Pre-dose, 1, 2, 3, 4 and 6 hour post-dose on Fraction Day 1 and Fraction Day 9 |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| Northwell Health, Inc | Great Neck | New York | 10042 | United States |
| Memorial Sloan-Kettering Cancer Center (MSKCC) - New York | New York | New York | 10065 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Ohio State University Clinical Trials Management Office - Ohio State CTMO Parent | Columbus | Ohio | 43210 | United States |
| University of Toledo Medical Center - Hematology/Oncology | Toledo | Ohio | 43614 | United States |
| Med. Univ. of South Carolina | Charleston | South Carolina | 29425 | United States |
| Greenville Hospital System University Medical Center (ITOR) | Greenville | South Carolina | 29605 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Hospital Universitari Vall d'Hebron - Dept of Oncology | Barcelona | Spain |
| Hospital Universitario 12 de Octubre - Servicio de Oncologia | Madrid | Spain |
| Hospital Regional Universitario de Malaga | Málaga | Spain |
| Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica | Valencia | Spain |
| FG001 |
| Peposertib 100 mg + RT + Capecitabine: |
Participants received peposertib 100 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
| FG002 | Peposertib 150 mg + RT + Capecitabine: | Participants received peposertib 150 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
| FG003 | Peposertib 250 mg + RT + Capecitabine: | Participants received peposertib 250 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
| Pharmacokinetic Analysis Set |
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| Full Analysis Set (FAS) |
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| Safety Analysis Set (SAF) |
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| COMPLETED |
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| NOT COMPLETED |
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The safety (SAF) analysis set included all participants who received at least 1 dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Peposertib 50 mg + RT + Capecitabine: | Participants received peposertib 50 milligram (mg) once daily in combination with capecitabine 825 milligram per square meter (mg/m^2) twice daily 5 days per week and radiotherapy (RT) of 50 to 50.4 Gray (Gy) to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
| BG001 | Peposertib 100 mg + RT + Capecitabine: | Participants received peposertib 100 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
| BG002 | Peposertib 150 mg + RT + Capecitabine: | Participants received peposertib 150 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
| BG003 | Peposertib 250 mg + RT + Capecitabine: | Participants received peposertib 250 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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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 | Number of Participants Who Experienced Dose Limiting Toxicity (DLT) Confirmed by Safety Monitoring Committee (SMC) | DLT is defined as any of following treatment emergent adverse events (TEAEs) considered possibly related to study treatment by Investigator and/or Sponsor up to completion of assigned chemoradiotherapy treatment. DLT were based on SMC: Adverse drug reaction that, in the opinion of SMC, is of potential clinical significance such that further dose escalation would expose participants to unacceptable risk; Any occurrence of drug-induced liver injury meeting the Hy's law criteria; Any Grade 3 toxicity excluding diarrhea, neutropenia lasting for ≤ 5 days, nausea & vomiting, Grade 3 thrombocytopenia without bleeding; Grade ≥ 4 AEs at least possibly related to study drug, irrespective of duration, excluding: Isolated Grade 4 lymphocytopenia without clinical symptoms; Neutropenia lasting for ≤ 5 days and not associated with fever; Any toxicity related to study drug that causes participant to receive > 80% of planned peposertib, capecitabine or RT dose. | Dose escalation (DE) analysis set included all participants treated in dose escalation cohorts, who received at least 80% of peposertib, 50% of capecitabine, and 80% of RT planned dose and complete DLT period (5 or 5.5 weeks after start of treatment or for the entire duration of treatment). DE set also included participants treated in dose escalation cohorts who experience a DLT during DLT period regardless of the amount of each study intervention received/completion of the DLT period. | Posted | Count of Participants | Participants | Time from first study intervention up to 19 weeks (including 5.5 weeks of treatment and 13.5 weeks of short term safety follow-up period) |
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| Secondary | Number of Participants Wtih Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs According to National Cancer Institute Common Terminology Criteria of Adverse Events (NCI-CTCAE) Version 5.0 | Adverse event (AE) is any untoward medical occurrence in participant administered pharmaceutical product, regardless of causal relationship with this treatment. Therefore, an AE can be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless if it is considered related to medicinal product. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after treatment start date. TEAEs included both serious and non-serious TEAEs. Treatment-related TEAEs: reasonably related to study intervention. Number of participants with TEAEs and treatment related TEAEs were reported. | SAF analysis set included all participants who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Time from first study intervention up to long term safety follow-up period (Up to Month 35) |
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| Secondary | Number of Participants With Abnormalities [Grade Greater Than or Equals to (>=) 3] in Laboratory Test Values | The laboratory measurements included hematology and biochemistry values were graded with National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 toxicity grades (where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening and Grade 5 = death). Number of participants with abnormalities Grade >= 3 in laboratory test values were reported. | SAF analysis set included all participants who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Time from first study intervention up to long term safety follow-up period (Up to Month 35) |
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| Secondary | Number of Participants With Markedly Abnormal Vital Sign Measurements | Vital sign assessments included assessments of heart rate, diastolic blood pressure, systolic blood pressure, respiratory rate and temperature. Number of participants with markedly abnormal vital sign measurements were reported. | SAF analysis set included all participants who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Time from first study intervention up to long term safety follow-up period (Up to Month 35) |
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| Secondary | Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings | Electrocardiograms (ECG) was obtained after the participant has been in a semi-supine position for at least 5 min. ECG parameters included heart rate, PQ/PR duration, QRS and QT duration, QT Interval. Clinical significance was determined by the investigator. Number of participants with clinically significant abnormalities in 12-lead ECG were reported. | SAF analysis set included all participants who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Time from first study intervention up to long term safety follow-up period (Up to Month 35) |
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| Secondary | Percentage of Participants With Composite Pathological Complete Response (pCR)/ Clinical Complete Response (cCR) | pCR: It is defined as absence of viable tumor cells in the primary tumor and lymph nodes. Participants considered to have a pCR if they undergo surgery and no residual cancer is found on histological examination of removed specimen. cCR: Participants are considered to have a cCR if: 1) Absence of any residual tumor in primary site and draining lymph nodes on imaging with magnetic resonance imaging; 2) No visible lesion at endoscopy except a flat scar, telangiectasia, and/or whitening of mucosa; 3) Absence of any palpable tumor or irregularity on digital rectal examination (DRE) and endoscopic ultrasonography (EUS); 4) If a biopsy is taken, it must be negative. Participants are considered as responders to composite endpoint pCR/cCR if participant had surgery and had pCR; participant did not undergo surgery but had cCR. Number of participants with composite pathological complete response (pCR)/ clinical complete response (cCR) were reported. | Full analysis set (FAS) include all participants who are enrolled in the study and received at least 1 dose of study intervention. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 15 |
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| Secondary | Disease-free Survival | Disease-free Survival time, defined as the time from first treatment day to the date of the first documentation of objective progressive disease or death due to any cause, whichever occurs first. Median disease-free survival time was estimated according to Kaplan-Meier method. | FAS include all participants who are enrolled in the study and received at least 1 dose of study intervention. As per the planned analysis, Kaplan-Meier estimates were planned to be presented as overall, together with a summary of associated statistics for this outcome measure. | Posted | Median | Full Range | Months | Time from first study intervention up to approximately 35 months |
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| Secondary | Percentage of Participants With Pathological Complete Response (pCR) | pCR is defined as the absence of viable tumor cells in the primary tumor and lymph nodes. Participants are considered to have a pCR if they undergo surgery and no residual cancer is found on histological examination of the removed specimen. | FAS include all participants who are enrolled in the study and received at least 1 dose of study intervention. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 15 |
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| Secondary | Percentage of Participants With Clinical Complete Response (cCR) | cCR: It is defined as participants considered to have a cCR if: 1) Absence of any residual tumor in the primary site and draining lymph nodes on imaging with magnetic resonance; 2) No visible lesion at endoscopy except a flat scar, telangiectasia, and/or whitening of the mucosa; 3) Absence of any palpable tumor or irregularity on digital rectal examination (DRE) and endoscopic ultrasonography (EUS); 4) If a biopsy is taken, it must be negative. | FAS include all participants who are enrolled in the study and received at least 1 dose of study intervention. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 15 |
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| Secondary | Time From Surgery to Local Recurrence | Time from surgery to local recurrence defined as time from day of surgery to the date of the first documentation of progression of disease, flagged as local recurrence. Median time from surgery to local recurrence was estimated according to Kaplan-Meier method. | FAS include all participants who are enrolled in the study and received at least 1 dose of study intervention. Here, number of participants analyzed signifies those participants who underwent rectal surgery. As per the planned analysis, Kaplan-Meier estimates were planned to be presented overall, together with a summary of associated statistics (median survival time and survival rate estimates) including the corresponding 2-sided 95% Confidence Intervals (CIs) for this outcome measure. | Posted | Median | Full Range | months | Time from surgery up to 15 months |
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| Secondary | Time From Surgery to Distant Metastasis | Time from surgery to distant metastasis defined as time from day of surgery to the date of the first documentation of progression of disease, flagged as distant metastasis. Median time from surgery to distant metastasis was estimated according to Kaplan-Meier method. | FAS include all participants who are enrolled in the study and received at least 1 dose of study intervention. Here, number of participants analyzed signifies those participants who underwent rectal surgery. As per the planned analysis, Kaplan-Meier estimates were planned to be presented overall, together with a summary of associated statistics for this outcome measure. | Posted | Median | Full Range | months | Time from surgery up to 15 months |
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| Secondary | Neoadjuvant Rectal (NAR) Score | The NAR formula includes the clinical tumor (cT) stage, pathologic tumor (pT), and node (pN) stage according to the tumor, node, metastasis classification system for colorectal cancers. The NAR formula is as follows: [5pN- 3 (cT- pT) + 12]2 / 9.61 NAR score ranges from 0 to 100, whereas a score close to 100 is indicative of a poorer prognosis. | FAS include all participants who are enrolled in the study and received at least 1 dose of study intervention. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | At Week 15 |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of Peposertib | Cmax was obtained directly from the concentration versus time curve. One participant was assigned to receive peposertib 100 mg; however, this participant took peposertib 50 mg for FD 1 through FD 10 and then took peposertib 100 mg for remainder of study participation. PK results for this participant was summarized by actual dose received (50 mg) whereas non-PK results are summarized by planned dose (100 mg). | Pharmacokinetic (PK) analysis set included participants who received at least 1 dose of peposertib and have sufficient peposertib plasma concentration data to enable the calculation of at least 1 PK parameter. Sufficient concentration data is defined as at least 3 valid, post dose, concentration points in the PK profile to obtain any PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Pre-dose, 1, 2, 3, 4 and 6 hours post-dose on Fraction Day 1 and Fraction Day 9 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to Last Sampling Time (Tlast) (AUC0-t) of Peposertib | 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 (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. | PK analysis set was used. One participant was assigned to receive peposertib 100 mg; however, this participant took peposertib 50 mg for FD 1 through FD 10 and then took peposertib 100 mg for remainder of study participation. PK results for this participant was summarized by actual dose received (50 mg) whereas non-PK results are summarized by planned dose (100 mg). | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliliter (h*ng/mL) | Pre-dose, 1, 2, 3, 4 and 6 hour post-dose on Fraction Day 1 and Fraction Day 9 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) of Peposertib | Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve. | PK analysis set was used. One participant was assigned to receive peposertib 100 mg; however, this participant took peposertib 50 mg for FD 1 through FD 10 and then took peposertib 100 mg for remainder of study participation. PK results for this participant was summarized by actual dose received (50 mg) whereas non-PK results are summarized by planned dose (100 mg). | Posted | Median | Full Range | hours | Pre-dose, 1, 2, 3, 4 and 6 hour post-dose on Fraction Day 1 and Fraction Day 9 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Total Body Clearance Following Oral Administration (CL/f) of Peposertib | 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. | PK analysis set was used. One participant was assigned to receive peposertib 100 mg; however, this participant took peposertib 50 mg for FD 1 through FD 10 and then took peposertib 100 mg for remainder of study participation. PK results for this participant was summarized by actual dose received (50 mg) whereas non-PK results are summarized by planned dose (100 mg). Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter per hour | Pre-dose, 1, 2, 3, 4 and 6 hour post-dose on Fraction Day 1 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Volume of Distribution (Vz/f) of Peposertib | The apparent volume of distribution during the terminal phase following extravascular administration, based on the fraction of dose absorbed. Vz/f = Dose/(AUC0-inf multiplied by Lambda z) following single dose. Vz/f= Dose/(AUCtau*Lambda z) following multiple dose. One participant was assigned to receive peposertib 100 mg; however, this participant took peposertib 50 mg for FD 1 through FD 10 and then took peposertib 100 mg for remainder of study participation. PK results for this participant was summarized by actual dose received (50 mg) whereas non-PK results are summarized by planned dose (100 mg). | PK analysis set was used. Here, "Number of participants" analyzed signifies those participants who were evaluable for this outcome measure. Here, "Number Analyzed" signified those participants who were evaluable at specified timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | Pre-dose, 1, 2, 3, 4 and 6 hour post-dose on Fraction Day 1 and Fraction Day 9 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Terminal Half-life (t1/2) of Peposertib | Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by lambda z. One participant was assigned to receive peposertib 100 mg; however, this participant took peposertib 50 mg for FD 1 through FD 10 and then took peposertib 100 mg for remainder of study participation. PK results for this participant was summarized by actual dose received (50 mg) whereas non-PK results are summarized by planned dose (100 mg). | PK analysis set was used. Here, "Number of participants" analyzed signifies those participants who were evaluable for this outcome measure. Here, "Number Analyzed" signified those participants who were evaluable at specified timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Pre-dose, 1, 2, 3, 4 and 6 hour post-dose on Fraction Day 1 and Fraction Day 9 |
|
Baseline up to long term follow-up period (approximately Month 35)
Not provided
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 | Peposertib 50 mg + RT + Capecitabine: | Participants received peposertib 50 milligram (mg) once daily in combination with capecitabine 825 milligram per square meter (mg/m^2) twice daily 5 days per week and radiotherapy (RT) of 50 to 50.4 Gray (Gy) to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG001 | Peposertib 100 mg + RT + Capecitabine: | Participants received peposertib 100 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. | 1 | 6 | 3 | 6 | 5 | 6 |
| EG002 | Peposertib 150 mg + RT + Capecitabine: | Participants received peposertib 150 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. | 1 | 6 | 0 | 6 | 6 | 6 |
| EG003 | Peposertib 250 mg + RT + Capecitabine: | Participants received peposertib 250 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. | 1 | 6 | 4 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Anal inflammation | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Dyschezia | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Rectal tenesmus | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Rectal ulcer | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Secretion discharge | General disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Anal injury | Injury, poisoning and procedural complications | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 24.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Personality change | Psychiatric disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Urinary hesitation | Renal and urinary disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Peripheral embolism | Vascular disorders | MedDRA version 24.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
As decided by sponsor study was discontinued prior to the initiation of the Phase II part of the study; therefore, results only from the Phase Ib part of the study was reported.
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 | Jul 7, 2021 | Jun 9, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000716216 | peposertib |
| D000069287 | Capecitabine |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D013812 | Therapeutics |
Not provided
Not provided
| 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 |
|
| OG001 | Peposertib 100 mg + RT + Capecitabine: | Participants received peposertib 100 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
| OG002 | Peposertib 150 mg + RT + Capecitabine: | Participants received peposertib 150 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
| OG003 | Peposertib 250 mg + RT + Capecitabine: | Participants received peposertib 250 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
|
|
| OG002 | Peposertib 150 mg + RT + Capecitabine: | Participants received peposertib 150 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
| OG003 | Peposertib 250 mg + RT + Capecitabine: | Participants received peposertib 250 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
|
|
Participants received peposertib 150 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
| OG003 | Peposertib 250 mg + RT + Capecitabine: | Participants received peposertib 250 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
|
|
| OG002 | Peposertib 150 mg + RT + Capecitabine: | Participants received peposertib 150 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
| OG003 | Peposertib 250 mg + RT + Capecitabine: | Participants received peposertib 250 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
|
|
| OG001 | Peposertib 100 mg + RT + Capecitabine: | Participants received peposertib 100 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
| OG002 | Peposertib 150 mg + RT + Capecitabine: | Participants received peposertib 150 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
| OG003 | Peposertib 250 mg + RT + Capecitabine: | Participants received peposertib 250 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
|
|
|
Participants received peposertib 150 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
| OG003 | Peposertib 250 mg + RT + Capecitabine: | Participants received peposertib 250 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
|
|
| OG002 | Peposertib 150 mg + RT + Capecitabine: | Participants received peposertib 150 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
| OG003 | Peposertib 250 mg + RT + Capecitabine: | Participants received peposertib 250 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
|
|
|
|
| OG002 |
| Peposertib 150 mg + RT + Capecitabine: |
Participants received peposertib 150 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
| OG003 | Peposertib 250 mg + RT + Capecitabine: | Participants received peposertib 250 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
|
|
| OG002 | Peposertib 150 mg + RT + Capecitabine: | Participants received peposertib 150 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
| OG003 | Peposertib 250 mg + RT + Capecitabine: | Participants received peposertib 250 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
|
|
| OG002 | Peposertib 150 mg + RT + Capecitabine: | Participants received peposertib 150 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
| OG003 | Peposertib 250 mg + RT + Capecitabine: | Participants received peposertib 250 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
|
|
| OG002 |
| Peposertib 150 mg + RT + Capecitabine: |
Participants received peposertib 150 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
| OG003 | Peposertib 250 mg + RT + Capecitabine: | Participants received peposertib 250 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
|
|
| OG002 | Peposertib 150 mg + RT + Capecitabine: | Participants received peposertib 150 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
| OG003 | Peposertib 250 mg + RT + Capecitabine: | Participants received peposertib 250 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
|
|
Participants received peposertib 100 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period.
| OG002 | Peposertib 150 mg + RT + Capecitabine: | Participants received peposertib 150 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
| OG003 | Peposertib 250 mg + RT + Capecitabine: | Participants received peposertib 250 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
|
|
| OG002 | Peposertib 150 mg + RT + Capecitabine: | Participants received peposertib 150 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
| OG003 | Peposertib 250 mg + RT + Capecitabine: | Participants received peposertib 250 mg once daily in combination with capecitabine 825 mg/m^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period. |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|