Phase 2
Completed N=83
Study of BMS-986158 in Subjects With Select Advanced Cancers
Source: ClinicalTrials.gov NCT02419417 ↗Enrolled (actual)
83
Serious AEs
54.2%
Results posted
Jun 2022
Primary outcomePrimary: Number of Participants Experiencing Adverse Events — 5; 4; 13; 10 Participants
Summary
The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986158 in subjects with select advanced cancers
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Adverse Events |
5; 4; 13; 10; 13; 4 | — |
| PRIMARY Number of Participants With Abnormal Hepatic Test Values |
2; 1; 2; 2; 2; 0 | — |
| SECONDARY Best Overall Response (BOR) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Objective Response Rate (ORR) |
0; 0; 0; 0; 7.7; 0 | — |
| SECONDARY Duration of Response (DOR) |
22.3; 42.4 | — |
| SECONDARY Progression Free Survival (PFS) |
4.57; 9.71; 7.57; 7.43; 13.79; 24.29 | — |
| SECONDARY Progression Free Survival Rate (PFSR) |
20.0; 33.3; 27.3; 11.1; 50.0; 50.0 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) - Single Dose Administration |
68.8; 175; 269; 368; 513; 5.00 | — |
| SECONDARY Time of Maximum Observed Plasma Concentration (Tmax) - Single Dose Administration |
4.00; 1.00; 1.04; 1.02; 2.02; 24.0 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose Administration |
1027; 2309; 3533; 4989; 7039; 98.2 | — |
| SECONDARY Apparent Terminal Phase Half-Life (T-HALF) - Single Dose Administration |
33.7; 48.7; 54.3; 42.7; 43.8; 35.3 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose Administration |
2479; 7013; 9775; 11677; 18974; 409 | — |
| SECONDARY Apparent Total Body Clearance (CLT/F) - Single Dose Administration |
5.04; 2.97; 3.41; 4.28; 3.95 | — |
| SECONDARY Apparent Volume of Distribution of Terminal Phase (Vz/F) - Single Dose Administration |
14.7; 12.5; 14.8; 14.4; 14.1 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) - Multiple Dose Administration |
68.8; 175; 260; 328; 478; 207 | — |
| SECONDARY Time to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose Administration |
4.00; 1.00; 2.00; 2.00; 2.04; 1.00 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose Administration |
2150; 6372; 8564; 10452; 19124; 5202 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose Administration |
1027; 2309; 3610; 4942; 6786; 2358 | — |
| SECONDARY Minimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose Administration |
73.7; 141; 208; 227; 428; 85.1 | — |
| SECONDARY Concentration at the End of Dosing Interval (C24) - Multiple Dose Administration |
33.5; 67.4; 108; 143; 210; 66.1 | — |
| SECONDARY Trough Observed Plasma Concentration (Ctrough) - Multiple Dose Administration |
35.7; 79.6; 142; 138; 257; 109 | — |
| SECONDARY Accumulation Index (AI) - Multiple Dose Administration |
1.89; 1.72; 1.76; 1.94; 1.79; 1.35 | — |
| SECONDARY Effective Elimination Half-Life (Effective T-HALF) - Multiple Dose Administration |
36.0; 25.7; 27.3; 14.4; 37.3; 31.6 | — |
| SECONDARY Ratio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose Administration |
0.073; 0.057; 0.068; 0.078; 0.068; 0.066 | — |
| SECONDARY 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 |
0.154; 0.127; 0.125; 0.152; 0.151; 0.081 | — |
| SECONDARY 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 |
0.177; 0.131; 0.120; 0.158; 0.164; 0.080 | — |
| SECONDARY 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 |
0.099; 0.081; 0.086; 0.097; 0.087; 0.081 | — |
| SECONDARY Change From Baseline in Electrocardiogram Parameter QTcF |
-6.8; -5.3; -3.3; -5.4; -10.2; -10.7 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02419417). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.