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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02419417
Registration number
NCT02419417
Ethics application status
Date submitted
2/04/2015
Date registered
17/04/2015
Date last updated
16/06/2022
Titles & IDs
Public title
Study of BMS-986158 in Subjects With Select Advanced Cancers
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Scientific title
A Phase I/IIa Trial With BMS-986158, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, as Monotherapy or in Combination With Nivolumab in Subjects With Selected Advanced Solid Tumors or Hematologic Malignancies
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Secondary ID [1]
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2015-000324-29
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Secondary ID [2]
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CA011-001
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Universal Trial Number (UTN)
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Trial acronym
BET
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Tumors
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BMS-986158
Other interventions - Nivolumab
Experimental: Monotherapy Treatment - Patients treated at various doses and schedules
Experimental: Combination Therapy - Patients treated at selected doses and schdules
Treatment: Drugs: BMS-986158
Specified dose on specified days
Other interventions: Nivolumab
Specified dose on specified days
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants Experiencing Adverse Events
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Assessment method [1]
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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.
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Timepoint [1]
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From first dose to 30 days following last dose (up to approximately 29 months)
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Primary outcome [2]
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Number of Participants With Abnormal Hepatic Test Values
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Assessment method [2]
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Number of participants experiencing abnormal hepatic function, as measured by different parameters.
ALT = Alanine aminotransferase AST = Aspartate aminotransferase ULN = Upper Limit of Normal
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Timepoint [2]
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From first dose to 30 days following last dose (up to approximately 29 months)
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Secondary outcome [1]
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Best Overall Response (BOR)
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Assessment method [1]
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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.
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Timepoint [1]
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From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months)
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Secondary outcome [2]
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Objective Response Rate (ORR)
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Assessment method [2]
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ORR is defined as the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR)
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Timepoint [2]
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From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months)
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Secondary outcome [3]
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Duration of Response (DOR)
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Assessment method [3]
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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.
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Timepoint [3]
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From date of first response to date of first objectively documented disease progression or death (up to approximately 42 weeks)
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Secondary outcome [4]
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Progression Free Survival (PFS)
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Assessment method [4]
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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.
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Timepoint [4]
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From first dose to date of first objectively documented disease progression or death (up to approximately 28 months)
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Secondary outcome [5]
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Progression Free Survival Rate (PFSR)
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Assessment method [5]
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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
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Timepoint [5]
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From first dose to 12 weeks, to 24 weeks, and to 48 weeks after first dose
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Secondary outcome [6]
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Maximum Observed Plasma Concentration (Cmax) - Single Dose Administration
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Assessment method [6]
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Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485
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Timepoint [6]
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From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
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Secondary outcome [7]
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Time of Maximum Observed Plasma Concentration (Tmax) - Single Dose Administration
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Assessment method [7]
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Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485
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Timepoint [7]
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From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
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Secondary outcome [8]
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Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose Administration
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Assessment method [8]
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Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485
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Timepoint [8]
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From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
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Secondary outcome [9]
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Apparent Terminal Phase Half-Life (T-HALF) - Single Dose Administration
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Assessment method [9]
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Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485
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Timepoint [9]
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From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
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Secondary outcome [10]
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Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose Administration
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Assessment method [10]
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Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485
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Timepoint [10]
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From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
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Secondary outcome [11]
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Apparent Total Body Clearance (CLT/F) - Single Dose Administration
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Assessment method [11]
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Values are reported only for the parent BMS-986158
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Timepoint [11]
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From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
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Secondary outcome [12]
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Apparent Volume of Distribution of Terminal Phase (Vz/F) - Single Dose Administration
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Assessment method [12]
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Values are reported only for the parent BMS-986158
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Timepoint [12]
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From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
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Secondary outcome [13]
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Maximum Observed Plasma Concentration (Cmax) - Multiple Dose Administration
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Assessment method [13]
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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)
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Timepoint [13]
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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)
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Secondary outcome [14]
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Time to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose Administration
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Assessment method [14]
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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)
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Timepoint [14]
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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)
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Secondary outcome [15]
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Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose Administration
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Assessment method [15]
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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)
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Timepoint [15]
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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)
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Secondary outcome [16]
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Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose Administration
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Assessment method [16]
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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)
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Timepoint [16]
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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)
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Secondary outcome [17]
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Minimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose Administration
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Assessment method [17]
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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)
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Timepoint [17]
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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)
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Secondary outcome [18]
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Concentration at the End of Dosing Interval (C24) - Multiple Dose Administration
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Assessment method [18]
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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)
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Timepoint [18]
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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)
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Secondary outcome [19]
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Trough Observed Plasma Concentration (Ctrough) - Multiple Dose Administration
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Assessment method [19]
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Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Values are also reported separately for the first and last collection
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Timepoint [19]
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From Cycle (C)2 Day (D)2 to C2D5 (Schedule A) or from C2D14 to C4D8 (Schedule B) or from C2D7 to C8D8 (Schedule C)
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Secondary outcome [20]
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Accumulation Index (AI) - Multiple Dose Administration
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Assessment method [20]
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AI is defined as the ratio of an exposure measure at steady-state to that after the first dose. Reported exposure measures include Cmax, C24 and AUC24.
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
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Timepoint [20]
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Cycle 2 Day 5 (Schedule A) or Cycle 2 Day 14 (Schedule B) or Cycle 2 Day 7 (Schedule C)
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Secondary outcome [21]
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Effective Elimination Half-Life (Effective T-HALF) - Multiple Dose Administration
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Assessment method [21]
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Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
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Timepoint [21]
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Cycle 2 Day 5 (Schedule A) or Cycle 2 Day 14 (Schedule B) or Cycle 2 Day 7 (Schedule C)
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Secondary outcome [22]
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Ratio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose Administration
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Assessment method [22]
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Values are 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)
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Timepoint [22]
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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)
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Secondary outcome [23]
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Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose Administration
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Assessment method [23]
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Values are 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)
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Timepoint [23]
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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)
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Secondary outcome [24]
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Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) to Parent (BMS-986158) AUC(INF) - Multiple Dose Administration
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Assessment method [24]
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Timepoint [24]
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Cycle 1 Day 1
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Secondary outcome [25]
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Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose Administration
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Assessment method [25]
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Values are 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)
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Timepoint [25]
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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)
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Secondary outcome [26]
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Change From Baseline in Electrocardiogram Parameter QTcF
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Assessment method [26]
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QT Interval corrected for Fridericia's Formula. Change from baseline is calculated from pre-dose at the indicated timepoints.
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Timepoint [26]
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From Cycle 1 Day 1 to last dosing day in Cycle 2 (C2D8 for Schedule A, C2D14 for Schedule B, C2D7 for Schedule C).
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Eligibility
Key inclusion criteria
- Must have select advanced cancers with specific genetic profiles
- Must have received appropriate standard of care
- At least one measurable lesion at baseline
- Expected to have life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) of 0 to 1
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Concomitant second malignancies
- Uncontrolled or significant cardiovascular disease
- Inadequate bone marrow function
- Chronic gastrointestinal illness
- Prior treatment with Bromodomain and Extra-Terminal (BET) inhibitor
Other protocol defined inclusion/exclusion criteria could apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/06/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/03/2021
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Sample size
Target
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Accrual to date
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Final
83
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Nucleus Network - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Colorado
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Massachusetts
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Oregon
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Pennsylvania
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Country [6]
0
0
United States of America
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State/province [6]
0
0
South Carolina
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Country [7]
0
0
Canada
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State/province [7]
0
0
Ontario
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Country [8]
0
0
France
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State/province [8]
0
0
Lyon Cedex 08
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Country [9]
0
0
France
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State/province [9]
0
0
Villejuif
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Country [10]
0
0
Spain
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State/province [10]
0
0
Barcelona
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Country [11]
0
0
Spain
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State/province [11]
0
0
Madrid
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Country [12]
0
0
Spain
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State/province [12]
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0
Pamplona
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and
pharmacodynamics of BMS-986158 in subjects with select advanced cancers
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02419417
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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0
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Phone
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
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0
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Country
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0
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Phone
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0
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Fax
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0
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Email
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0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02419417
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