Description:
The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and
pharmacodynamics of BMS-986158 in subjects with select advanced cancers
Title
- Brief Title: Study of BMS-986158 in Subjects With Select Advanced Cancers
- Official 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
Clinical Trial IDs
- ORG STUDY ID:
CA011-001
- SECONDARY ID:
2015-000324-29
- NCT ID:
NCT02419417
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| BMS-986158 | | Combination Therapy |
| Nivolumab | BMS-936558, Opdivo | Combination Therapy |
Purpose
The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and
pharmacodynamics of BMS-986158 in subjects with select advanced cancers
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Monotherapy Treatment | Experimental | Patients treated at various doses and schedules | |
| Combination Therapy | Experimental | Patients treated at selected doses and schdules | |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
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
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 12 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Number of Adverse Events (AEs) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Best Overall Response |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Objective Response Rate (ORR) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Duration of Response |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Maximum observed plasma concentration (Cmax) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Time of maximum observed plasma concentration (Tmax) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Area under the concentration-time curve in one dosing interval (AUC(TAU)) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Apparent terminal phase half-life (T-HALF) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Apparent total body clearance, reported only for parent, not for metabolite (CLT/F) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Apparent volume of distribution of terminal phase, reported only for parent, not for metabolite (Vz/F) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Minimum observed concentration within a dosing interval (Cmin) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Concentration at the end of a dosing interval (Ctau) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Trough observed plasma concentration (this includes predose concentrations (C0) and concentrations at the end of dosing interval (Ctau)) (Ctrough) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Degree of Fluctuation or Fluctuation Index ([Cmax-Cmin)/Css-avg]) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | [Cmax - Cmin] / Cmin; to be calculated at steady-state (Swing) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Accumulation Index (AI) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | Ratio of an exposure measure at steady-state to that after the first dose (exposure measure includes AUC(TAU), Cmax and Ctau) |
| Measure: | Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (T-HALFeff) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Ratio of metabolite AUC(0-T) to parent AUC(0-T), corrected for molecular weight (MR_AUC(0-T)) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight (following single dose only) (MR_AUC(INF)) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight (MR_AUC(TAU)) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Electrocardiogram (ECG) QT (time of ventricular activity including both depolarization and repolarization) Interval |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
March 12, 2021
