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A Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 in Participants with Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumors

ABSTRACT: Interventions: investigational material(s) Generic name etc : TAK-931 INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : TAK-931 50 mg, capsules, orally, once daily for 14 days, followed by 7-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 1 year). control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : - Primary outcome(s): safety Percentage of Participants with Dose Limiting Toxicities (DLTs) in Western Safety Cohort Timeframe; Cycle 1 (each cycle = 21 days) DLT: Any following event related to TAK-931 assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03; Non-febrile Grade 4 neutropenia lasting more than 7 consecutive days; Febrile neutropenia: Grade >=3 neutropenia with fever and/or infection; Grade 4 thrombocytopenia; Grade >=3 thrombocytopenia of any duration accompanied by Grade 2 bleeding or requiring transfusion; delay in the initiation of cycle 2 by more than 14 days due to a lack of adequate recovery of treatment-related hematological or nonhematologic toxicities; Grade 2 ejection fraction decreased by ECHO or MUGA scan; Grade 4 laboratory abnormalities; other Grade 2 nonhematologic toxicities considered by the investigator to be related to study drug and dose-limiting; Participants receiving <50% of doses (<7 doses) of the planned TAK-931 dosing in cycle 1 due to study drug-related adverse events (AEs); Grade >=3 nonhematologic toxicity with the few exceptions: Grade 3 arthralgia/ myalgia, fatigue, laboratory abnormalities, nausea and/or emesis or diarrhea. safety Percentage of Participants with Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs Leading to Dose Modifications and TEAEs Leading to Treatment Discontinuation in Western Safety Cohort Timeframe; From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months) An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. An SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. efficacy Disease Control Rate (DCR) in Tumor Specific Cohorts Timeframe; Up to end of treatment (Up to approximately 14 months) DCR is defined as percentage of participants documented to have unconfirmed complete response (CR), partial response (PR) or stable disease (SD) >=6 weeks from treatment initiation according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1) as the best response.. CR is defined as disappearance of all lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of lesions, taking as reference the baseline sum LD. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started. (PD is defined as at least a 20% increase in the sum of the LD of lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Study Design: Open-Label, Parallel Arm Study

DISEASE(S): Esophageal Neoplasms,Metastatic Pancreatic Cancer,Colorectal Cancer,Carcinoma, Non-small-cell Lung

PROVIDER: 102033 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Intervention name : TAK-931 INN of the intervention : - Dosage And administration of the intervention : TAK-931 50 mg, capsules, orally, once daily for 14 days, followed by 7-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 1 year). Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - Primary outcome(s): safety Percentage of Participants with Dose Limiting Toxicities (DLTs) in Western Safety Cohort Timeframe; Cycle 1 (each cycle = 21 days) DLT: Any following event related to TAK-931 assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03; Non-febrile Grade 4 neutropenia lasting more than 7 consecutive days; Febrile neutropenia: Grade >=3 neutropenia with fever and/or infection; Grade 4 thrombocytopenia; Grade >=3 thrombocytopenia of any duration accompanied by Grade 2 bleeding or requiring transfusion; delay in the initiation of cycle 2 by more than 14 days due to a lack of adequate recovery of treatment-related hematological or nonhematologic toxicities; Grade 2 ejection fraction decreased by ECHO or MUGA scan; Grade 4 laboratory abnormalities; other Grade 2 nonhematologic toxicities considered by the investigator to be related to study drug and dose-limiting; Participants receiving <50% of doses (<7 doses) of the planned TAK-931 dosing in cycle 1 due to study drug-related adverse events (AEs); Grade >=3 nonhematologic toxicity with the few exceptions: Grade 3 arthralgia/ myalgia, fatigue, laboratory abnormalities, nausea and/or emesis or diarrhea. safety Percentage of Participants with Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs Leading to Dose Modifications and TEAEs Leading to Treatment Discontinuation in Western Safety Cohort Timeframe; From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months) An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. An SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. efficacy Disease Control Rate (DCR) in Tumor Specific Cohorts Timeframe; Up to end of treatment (Up to approximately 14 months) DCR is defined as percentage of participants documented to have unconfirmed complete response (CR), partial response (PR) or stable disease (SD) >=6 weeks from treatment initiation according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1) as the best response.. CR is defined as disappearance of all lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of lesions, taking as reference the baseline sum LD. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started. (PD is defined as at least a 20% increase in the sum of the LD of lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Study Design: Open-Label, Parallel Arm Study

Project description:Interventions: investigational material(s) Generic name etc : panitumumab, TAS-102 INN of investigational material : panitumumab, trifluridine + tipiracil Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Investigational material : Panitumumab 6 mg/kg every 2 weeks, plus TAS-102 35 mg/m^2 given orally twice a day in 5 days followed by a 2-day rest period for 2-week cycle, and then a 14-day rest period (28 days per 1 course). control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : - Primary outcome(s): safety Number of Participants With Dose Limiting Toxicity (DLT) with Panitumumab plus TAS-102 Combination Therapy Timeframe: Up to approximately 1 month DLT was evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 and was defined as any of the following events: 1. Grade 4 neutropenia for more than 7 days under maximum supportive therapy; 2. Febrile neutropenia; 3. Platelet counts decreased of Grade 3 requiring platelet transfusion or blood platelet decreased of Grade 4; 4. If Course 2 was not initiated within 14 days due to AE related to the protocol treatment; 5. Grade 3 or higher non-hematologic toxicity that was considered clinically significant, except the following cases, Grade 3 gastrointestinal symptoms that could be controlled with supportive therapy (eg, appropriate use of antiemetics, antidiarrheals), and Grade 3 or higher electrolyte abnormalities that were not deemed clinically significant. efficacy Progression Free Survival (PFS) Rate at 6 Months Timeframe: Up to 6 months PFS rate at 6 months was defined as the crude rate of surviving participants who survived or were not determined as progressive at 6 months from the day of enrollment. Although the subjects who had no imaging data on progression at 6 months after enrollment or the subjects who had lost to follow-up were included in the denominator, these subjects were not handled as progression-free. Study Design: Exploratory Study

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A Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 in Participants with Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumors

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