Trial · NCT03271047
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLT) | Cycle 1: Day 1 up to Day 28 | Dose-Determining Set (DDS) included all participants in Phase 1b who experienced a DLT or receive at least 75% of the planned binimetinib dose intensity during Cycle 1. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | From start of the treatment until disease progression, death or initiation of new anticancer therapy, whichever occurred first (Phase 2: maximum up to 26 months approximately) | All participants randomized to study treatment in Phase 2. | Percentage of participants | NUMBER |
| SECONDARY | Phase 1b: Objective Response Rate (ORR) Per RECIST v1.1 | From start of the treatment until disease progression, death or initiation of new anticancer therapy, whichever occurred first (Phase 1b: maximum up to 9 months approximately) | All participants who received at least 1 dose of any study treatment in Phase 1b. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) as Per RECIST v1.1 | From date of first documented CR/PR to date of first documented PD, death or initiation of new anticancer therapy, whichever occurred first (Phase 1b: maximum up to 9 months approximately, Phase 2: maximum up to 26 months approximately) | FAS included all participants who received at least 1 dose of any study drug in Phase 1b and all participants randomized to study treatment in Phase 2. Here, Overall Number of Participants Analyzed signifies number of participants who achieved an objective response. There were no participants who had event in Phase 1b and Nivolumab and Binimetinib group of Phase 2. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Complete Response as Per RECIST v1.1 | From start of the treatment until disease progression, death or initiation of new anticancer therapy, whichever occurred first (Phase 1b: maximum up to 9 months approximately and Phase 2: maximum up to 26 months approximately) | FAS included all participants who received at least 1 dose of any study drug in Phase 1b and all participants randomized to study treatment in Phase 2. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAE) Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (Phase 1b: maximum up to 9 months approximately and Phase 2: maximum up to 26 months approximately) | The safety set included of all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately) | Safety set included of all participants who received at least 1 dose of study drug. Here Number Analyzed signifies number of participants evaluable for specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately) | Safety set included of all participants who received at least 1 dose of study drug. Here Number Analyzed signifies number of participants evaluable for specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately) | Safety set included of all participants who received at least 1 dose of study drug. Here Number Analyzed signifies number of participants evaluable for specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately) | Safety set included of all participants who received at least 1 dose of study drug. Here Number Analyzed signifies number of participants evaluable for specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormal Hepatic Laboratory Values | Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately) | Safety set included of all participants who received at least 1 dose of study drug. Here Number Analyzed signifies number of participants evaluable for specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | 1.5 hours post dose of binimetinib on Day 1, 15 of Cycle 1; pre dose of binimetinib on Day 15 of Cycle 1, 2, 3, 4, 5 | The pharmacokinetic analysis set included of all participants who received at least 1 dose of binimetinib and have at least one evaluable bioanalytical result. Here Number Analyzed signifies number of participants evaluable for specified rows. | nanogram per milliliter | GEOMETRIC_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03271047/outcomes