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

简要总结

主要结局

次要结局

• Duration of Response (DOR)(From date of first response to date of first objectively documented disease progression or death (up to approximately 42 weeks))
• Maximum Observed Plasma Concentration (Cmax) - Single Dose Administration(From drug administration in Cycle 1 Day 1 to 168 hours post drug administration)
• 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)
• Apparent Terminal Phase Half-Life (T-HALF) - Single Dose Administration(From drug administration in Cycle 1 Day 1 to 168 hours post drug administration)
• Best Overall Response (BOR)(From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months))
• Objective Response Rate (ORR)(From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months))
• Progression Free Survival (PFS)(From first dose to date of first objectively documented disease progression or death (up to approximately 28 months))
• Progression Free Survival Rate (PFSR)(From first dose to 12 weeks, to 24 weeks, and to 48 weeks after first dose)
• Time of Maximum Observed Plasma Concentration (Tmax) - Single Dose Administration(From drug administration in Cycle 1 Day 1 to 168 hours post drug administration)
• 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)
• Apparent Total Body Clearance (CLT/F) - Single Dose Administration(From drug administration in Cycle 1 Day 1 to 168 hours post drug administration)
• 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)
• 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))
• 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))
• 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))
• 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))
• 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))
• 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))
• Trough Observed Plasma Concentration (Ctrough) - Multiple Dose Administration(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))
• Accumulation Index (AI) - Multiple Dose Administration(Cycle 2 Day 5 (Schedule A) or Cycle 2 Day 14 (Schedule B) or Cycle 2 Day 7 (Schedule C))
• Effective Elimination Half-Life (Effective T-HALF) - Multiple Dose Administration(Cycle 2 Day 5 (Schedule A) or Cycle 2 Day 14 (Schedule B) or Cycle 2 Day 7 (Schedule C))
• Ratio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) 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))
• 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(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))
• 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(Cycle 1 Day 1)
• 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(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))
• Change From Baseline in Electrocardiogram Parameter QTcF(From Cycle 1 Day 1 to last dosing day in Cycle 2 (C2D8 for Schedule A, C2D14 for Schedule B, C2D7 for Schedule C).)