Not provided
Not provided
Not provided
Not provided
Not provided
Overarching portfolio-level review of the company's oncology pipeline resulted in early termination of the study. The study was not terminated due to safety.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this study was to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and early signs of efficacy of M1069 in participants with advanced solid malignancies.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M1069 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M1069 | Drug | Participants received escalated oral dose of M1069, twice daily (BID) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-Limiting Toxicities (DLTs) | A DLT was defined as any AE, per National Cancer Institute - Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0), assessed by the Investigator or Sponsor at any dose, unrelated to underlying disease, prior/concomitant medication, or condition, occurring during the DLT observation period. DLTs included Grade more than equal to (≥) 3 thrombocytopenia with bleeding, excluding isolated Grade 4 lymphopenia without symptoms or Grade 4 neutropenia/thrombocytopenia less than (<) 7 days without signs. Other DLTs were Hy's Law hepatotoxicity without clear cause, vision changes (≥5-line Best Corrected Visual Acuity (BCVA) loss, BCVA <20/160, MD >9 decibel (dB), macular thickness >25 percentage (%)), severe eye disorders limiting self-care, ≥5-day drug interruption to prevent DLT. | Cycle 1 (first 21 days after first study drug administration) |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment Related TEAEs and Serious TEAEs | An AE can be any unfavorable and unintended sign, symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. For surgical or diagnostic procedures, the condition/illness leading to such a procedure is considered as the AE rather than the procedure itself. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. An AE was considered as 'treatment emergent' if it occurred after the first drug administration of each period or if it was present prior to drug administration but exacerbated after the drug administration. TEAEs included both serious TEAEs and non-serious TEAEs. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization, results in persistent disability. Treatment Related TEAEs are also reported. | Up to 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Time of Last Measurable Concentration (AUC0-tlast) of M1069 | The AUC from time zero (= dosing time) to the last sampling time (tlast) at which the concentration is at or above the lower limit of quantification. Calculated using the mixed log-linear trapezoidal rule (linear up, log down). | Day 8 and 15 of Cycle 1 and Day 1 of Cycle 4 (each cycle is of 21 days) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | EMD Serono Research & Development Institute, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States | ||
| Sarah Cannon Research Institute (SCRI) (The SCRI Oncology Research Consortium) |
Not provided
| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| US Medical Information website, Medical Resources | View source |
Not provided
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 https://bit.ly/IPD21
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | M1069 150 mg BID | Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 150 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention. |
| FG001 | M1069 300 mg BID | Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 300 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention. |
| FG002 | M1069 450 mg BID | Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 450 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention. |
| FG003 | M1069 600 mg BID | Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 600 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | M1069 150 mg BID | Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 150 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose-Limiting Toxicities (DLTs) | A DLT was defined as any AE, per National Cancer Institute - Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0), assessed by the Investigator or Sponsor at any dose, unrelated to underlying disease, prior/concomitant medication, or condition, occurring during the DLT observation period. DLTs included Grade more than equal to (≥) 3 thrombocytopenia with bleeding, excluding isolated Grade 4 lymphopenia without symptoms or Grade 4 neutropenia/thrombocytopenia less than (<) 7 days without signs. Other DLTs were Hy's Law hepatotoxicity without clear cause, vision changes (≥5-line Best Corrected Visual Acuity (BCVA) loss, BCVA <20/160, MD >9 decibel (dB), macular thickness >25 percentage (%)), severe eye disorders limiting self-care, ≥5-day drug interruption to prevent DLT. | DLT set included all participants who received more than or equal to (>=) 1 M1069 dose and with at least 1 DLT during the DLT period, and/or received at least 80% of the planned cumulative dose during the DLT period, and/or did not receive 80% of the planned total dose, but at least 80% dosing of a different dose cohort and finished the DLT period. | Posted | Count of Participants | Participants | Cycle 1 (first 21 days after first study drug administration) |
Up to 17.3 months
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 | M1069 150 mg BID | Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 150 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@emdgroup.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 11, 2021 | Jan 15, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 22, 2023 | Jan 15, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Area Under Plasma Concentration Time Curve From Time Zero to 24, Divided by Dose (AUC [0-24]/D) of M1069 | AUC [0-24]/D is the Area under plasma concentration time curve from time zero to 24 divided by dose (AUC [0-24]/D) of M1069. Calculated using the mixed log-linear trapezoidal rule (linear up, log down). | Day 8 and 15 of Cycle 1 and Day 1 of Cycle 4 (each cycle is of 21 days) |
| Maximum Observed Plasma Concentration (Cmax) of M1069 | Cmax is the maximum observed plasma concentration and was obtained directly from the concentration versus time curve. | Day 8 and 15 of Cycle 1 and Day 1 of Cycle 4 (each cycle is of 21 days) |
| Maximum Observed Plasma (Peak) Drug Concentration, by Dose (Cmax/D) | Cmax/D is the maximum observed plasma concentration by dose. Cmax was obtained directly from the concentration versus time curve, divided by Dose of M1069. | Day 8 and 15 of Cycle 1 and Day 1 of Cycle 4 (each cycle is of 21 days) |
| Time to Reach Peak or Maximum Observed Concentration or Response Following Drug Administration (Tmax) | The time to reach the maximum observed plasma concentration (Tmax) was obtained directly from the concentration versus time curve. | Day 8 and 15 of Cycle 1 and Day 1 of Cycle 4 (each cycle is of 21 days) |
| Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), as Assessed by Investigator | OR is defined as a best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all target lesions. Number of participants with BOR of CR or PR was reported. | Time from first observation of response (CR or PR) up to planned assessment at 17.3 months |
| Duration of Response (DoR) | DoR is the time from when the complete response (CR) or partial response (PR) (whichever is first) criteria are first met until disease progression (PD) or death due to any cause within the period of 2 scheduled tumor assessments after the last tumor assessment, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | Time from first observation of response (CR or PR) up to planned assessment at 17.3 months |
| Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), as Assessed by Investigator | PFS is defined as the time (in months) from first administration of study intervention to the date of the first documentation of progression disease (PD) or death due to any cause within the period of 2 scheduled tumor assessments after the last tumor assessment, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was to be estimated using Kaplan-Meier (KM) plots. | Time from first administration of study intervention to the date of the first documentation of progression disease (PD) or death due to any cause within, whichever occurs first, assessed up to maximum of 17.3 months |
| Change From Baseline in Corrected QT (QTc) Interval | A 12-lead ECG was recorded with the participant in a supine position after a rest of at least 10 minutes using an ECG machine. Change from baseline in QTc interval was reported. In the Timeframe the "C" refers to Cycle, "D" refers to Day and "h" refers to the hours. | Cycle (C)1Day (D)1: 1h, 2h, 4h, 6h, 8h post-dose; C1D8: 15min predose, 1h, 2h, 4h, 6h, 8h post-dose; C1D15: predose; C2D1: predose, 2h post-dose; C4D1, C6D1, C10D1, C12D1, C14D1, C18D1(each cycle is of 21 days) |
| Nashville |
| Tennessee |
| 37203 |
| United States |
| Princess Margaret Cancer Centre | Toronto | Canada |
| Study Closing |
|
| Started New Cancer Therapy |
|
| M1069 300 mg BID |
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 300 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention. |
| BG002 | M1069 450 mg BID | Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 450 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention. |
| BG003 | M1069 600 mg BID | Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 600 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | M1069 150 mg BID | Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 150 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention. |
| OG001 | M1069 300 mg BID | Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 300 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention. |
| OG002 | M1069 450 mg BID | Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 450 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention. |
| OG003 | M1069 600 mg BID | Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 600 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention. |
|
|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment Related TEAEs and Serious TEAEs | An AE can be any unfavorable and unintended sign, symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. For surgical or diagnostic procedures, the condition/illness leading to such a procedure is considered as the AE rather than the procedure itself. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. An AE was considered as 'treatment emergent' if it occurred after the first drug administration of each period or if it was present prior to drug administration but exacerbated after the drug administration. TEAEs included both serious TEAEs and non-serious TEAEs. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization, results in persistent disability. Treatment Related TEAEs are also reported. | The Safety analysis set (SAF) included all participants who were administered any dose of any study intervention. | Posted | Count of Participants | Participants | Up to 16 months |
|
|
|
| Secondary | Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Time of Last Measurable Concentration (AUC0-tlast) of M1069 | The AUC from time zero (= dosing time) to the last sampling time (tlast) at which the concentration is at or above the lower limit of quantification. Calculated using the mixed log-linear trapezoidal rule (linear up, log down). | Pharmacokinetic (PK) analysis set included all participants who received at least one dose of study intervention and provided at least one measurable post-dose concentration that is unaffected by any protocol deviations or events that affect its validity. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour* nanograms per milliliter (h*ng/mL) | Day 8 and 15 of Cycle 1 and Day 1 of Cycle 4 (each cycle is of 21 days) |
|
|
|
| Secondary | Area Under Plasma Concentration Time Curve From Time Zero to 24, Divided by Dose (AUC [0-24]/D) of M1069 | AUC [0-24]/D is the Area under plasma concentration time curve from time zero to 24 divided by dose (AUC [0-24]/D) of M1069. Calculated using the mixed log-linear trapezoidal rule (linear up, log down). | The Pharmacokinetic analysis set included all participants who received at least one dose of study intervention and provided at least one measurable post-dose concentration that is unaffected by any protocol deviations or events that affect its validity. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL/mg | Day 8 and 15 of Cycle 1 and Day 1 of Cycle 4 (each cycle is of 21 days) |
|
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) of M1069 | Cmax is the maximum observed plasma concentration and was obtained directly from the concentration versus time curve. | The Pharmacokinetic analysis set included all participants who received at least one dose of study intervention and provided at least one measurable post-dose concentration that is unaffected by any protocol deviations or events that affect its validity. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per mililiter (ng/mL) | Day 8 and 15 of Cycle 1 and Day 1 of Cycle 4 (each cycle is of 21 days) |
|
|
|
| Secondary | Maximum Observed Plasma (Peak) Drug Concentration, by Dose (Cmax/D) | Cmax/D is the maximum observed plasma concentration by dose. Cmax was obtained directly from the concentration versus time curve, divided by Dose of M1069. | The Pharmacokinetic analysis set included all participants who received at least one dose of study intervention and provided at least one measurable post-dose concentration that is unaffected by any protocol deviations or events that affect its validity. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL/mg | Day 8 and 15 of Cycle 1 and Day 1 of Cycle 4 (each cycle is of 21 days) |
|
|
|
| Secondary | Time to Reach Peak or Maximum Observed Concentration or Response Following Drug Administration (Tmax) | The time to reach the maximum observed plasma concentration (Tmax) was obtained directly from the concentration versus time curve. | The Pharmacokinetic analysis set included all participants who received at least one dose of study intervention and provided at least one measurable post-dose concentration that is unaffected by any protocol deviations or events that affect its validity. | Posted | Median | Full Range | hours | Day 8 and 15 of Cycle 1 and Day 1 of Cycle 4 (each cycle is of 21 days) |
|
|
|
| Secondary | Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), as Assessed by Investigator | OR is defined as a best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all target lesions. Number of participants with BOR of CR or PR was reported. | The Safety analysis included all participants who were administered any dose of any study intervention. | Posted | Count of Participants | Participants | Time from first observation of response (CR or PR) up to planned assessment at 17.3 months |
|
|
|
| Secondary | Duration of Response (DoR) | DoR is the time from when the complete response (CR) or partial response (PR) (whichever is first) criteria are first met until disease progression (PD) or death due to any cause within the period of 2 scheduled tumor assessments after the last tumor assessment, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | None of the participants showed objective response, hence Duration of Response was not evaluable. | Posted | Time from first observation of response (CR or PR) up to planned assessment at 17.3 months |
|
|
| Secondary | Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), as Assessed by Investigator | PFS is defined as the time (in months) from first administration of study intervention to the date of the first documentation of progression disease (PD) or death due to any cause within the period of 2 scheduled tumor assessments after the last tumor assessment, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was to be estimated using Kaplan-Meier (KM) plots. | The Safety analysis included all participants who were administered any dose of any study intervention. | Posted | Median | Full Range | months | Time from first administration of study intervention to the date of the first documentation of progression disease (PD) or death due to any cause within, whichever occurs first, assessed up to maximum of 17.3 months |
|
|
|
| Secondary | Change From Baseline in Corrected QT (QTc) Interval | A 12-lead ECG was recorded with the participant in a supine position after a rest of at least 10 minutes using an ECG machine. Change from baseline in QTc interval was reported. In the Timeframe the "C" refers to Cycle, "D" refers to Day and "h" refers to the hours. | The Safety analysis included all participants who were administered any dose of any study intervention. | Posted | Mean | Full Range | milliseconds | Cycle (C)1Day (D)1: 1h, 2h, 4h, 6h, 8h post-dose; C1D8: 15min predose, 1h, 2h, 4h, 6h, 8h post-dose; C1D15: predose; C2D1: predose, 2h post-dose; C4D1, C6D1, C10D1, C12D1, C14D1, C18D1(each cycle is of 21 days) |
|
|
|
| 0 |
| 3 |
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | M1069 300 mg BID | Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 300 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention. | 0 | 3 | 2 | 3 | 3 | 3 |
| EG002 | M1069 450 mg BID | Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 450 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention. | 1 | 6 | 0 | 6 | 6 | 6 |
| EG003 | M1069 600 mg BID | Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 600 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention. | 1 | 3 | 0 | 3 | 2 | 3 |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Retinal degeneration | Eye disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Metastases to skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Non-systematic Assessment |
|
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Menstrual disorder | Reproductive system and breast disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Participants with Serious TEAEs |
|
| Participants with Treatment related TEAEs |
|
| Partial Response |
|
|
| C1D1 2h post-dose |
|
|
| C1D1 4h post-dose |
|
|
| C1D1 6h post-dose |
|
|
| C1D1 8h post-dose |
|
|
| C1D8 15min Predose |
|
|
| C1D8 1h Post dose |
|
|
| C1D8 2h post-dose |
|
|
| C1D8 4h post-dose |
|
|
| C1D8 6h post-dose |
|
|
| C1D8 8h Post dose |
|
|
| C1D15 Predose |
|
|
| C2D1 Predose |
|
|
| C2D1 2h post-dose |
|
|
| C4D1 Predose |
|
|
| C6D1 Predose |
|
|
| C10D1 |
|
|
| C12D1 |
|
|
| C14D1 |
|
|
| C18D1 |
|
|