Trial · NCT02419417
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experiencing Adverse Events | From first dose to 30 days following last dose (up to approximately 29 months) | Number of participants experiencing different types of events, including Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to discontinuation and deaths. Events are classified based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. |
| Primary | Number of Participants With Abnormal Hepatic Test Values | From first dose to 30 days following last dose (up to approximately 29 months) | Number of participants experiencing abnormal hepatic function, as measured by different parameters. ALT = Alanine aminotransferase AST = Aspartate aminotransferase ULN = Upper Limit of Normal |
| Secondary | Best Overall Response (BOR) | From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months) | BOR, as assessed by the investigator, is defined as the best response designation, recorded between the dates of first dose and the date of first objectively documented progression (per RECIST v1.1 for solid tumors, Lugano 2014 criteria for hematologic malignancies or PCWG3 for prostate cancer) or the date of subsequent therapy, whichever occurs first. |
| Secondary | Objective Response Rate (ORR) | From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months) | ORR is defined as the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) |
| Secondary | Duration of Response (DOR) | From date of first response to date of first objectively documented disease progression or death (up to approximately 42 weeks) | DOR is defined as the time between the date of first response and the date of the first objectively documented disease progression (as determined by RECIST v1.1 for solid tumors, Lugano 2014 criteria for hematologic malignancies, or PCWG3 (including PSA assessments) for prostate cancer \[CRPC or NEPC\]), or death due to any cause, whichever occurs first. |
| Secondary | Progression Free Survival (PFS) | From first dose to date of first objectively documented disease progression or death (up to approximately 28 months) | PFS is defined as the time from the first dose of study medication to the date of the first objective documentation of tumor progression or death due to any cause. |
| Secondary | Progression Free Survival Rate (PFSR) | From first dose to 12 weeks, to 24 weeks, and to 48 weeks after first dose | PFSR is defined as the percentage of participants who remain progression free and surviving at the specified timepoints (12 weeks, 24 weeks, and 48 weeks). Reported values are estimates derived from Kaplan-Meier analyses |
| Secondary | Maximum Observed Plasma Concentration (Cmax) - Single Dose Administration | From drug administration in Cycle 1 Day 1 to 168 hours post drug administration | Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485 |
| Secondary | Time of Maximum Observed Plasma Concentration (Tmax) - Single Dose Administration | From drug administration in Cycle 1 Day 1 to 168 hours post drug administration | Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485 |
| Secondary | Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose Administration | From drug administration in Cycle 1 Day 1 to 168 hours post drug administration | Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485 |
| Secondary | Apparent Terminal Phase Half-Life (T-HALF) - Single Dose Administration | From drug administration in Cycle 1 Day 1 to 168 hours post drug administration | Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485 |
| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose Administration | From drug administration in Cycle 1 Day 1 to 168 hours post drug administration | Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485 |
| Secondary | Apparent Total Body Clearance (CLT/F) - Single Dose Administration | From drug administration in Cycle 1 Day 1 to 168 hours post drug administration | Values are reported only for the parent BMS-986158 |
| Secondary | Apparent Volume of Distribution of Terminal Phase (Vz/F) - Single Dose Administration | From drug administration in Cycle 1 Day 1 to 168 hours post drug administration | Values are reported only for the parent BMS-986158 |
| Secondary | Maximum Observed Plasma Concentration (Cmax) - Multiple Dose Administration | From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C) | Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485. Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C) |
| Secondary | Time to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose Administration | From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C) | Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485. Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C) |
| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose Administration | From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C) | Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485. Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C) |
| Secondary | Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose Administration | From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C) | Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485. Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C) |
| Secondary | Minimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose Administration | From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C) | Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485. Values are reported only for the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C) |
| Secondary | Concentration at the End of Dosing Interval (C24) - Multiple Dose Administration | From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C) | Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485. Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C) |
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
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GET https://conductscience.org/api/trials/v1/NCT02419417/registered