Clinical Trials /

Study of BMS-986158 in Subjects With Select Advanced Cancers

NCT02419417

Description:

The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986158 in subjects with select advanced cancers

Related Conditions:
  • Cancer
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

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

  • Advanced Tumors

Interventions

DrugSynonymsArms
BMS-986158Combination Therapy
NivolumabBMS-936558, OpdivoCombination 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

NameTypeDescriptionInterventions
Monotherapy TreatmentExperimentalPatients treated at various doses and schedules
  • BMS-986158
Combination TherapyExperimentalPatients treated at selected doses and schdules
  • BMS-986158
  • Nivolumab

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:Recruiting
Lead Sponsor:Bristol-Myers Squibb

Last Updated

January 24, 2020