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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02419417




Registration number
NCT02419417
Ethics application status
Date submitted
2/04/2015
Date registered
17/04/2015
Date last updated
11/08/2020

Titles & IDs
Public title
Study of BMS-986158 in Subjects With Select Advanced Cancers
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
Secondary ID [1] 0 0
2015-000324-29
Secondary ID [2] 0 0
CA011-001
Universal Trial Number (UTN)
Trial acronym
BET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Adverse Events (AEs)
Timepoint [1] 0 0
Up to 4 years
Primary outcome [2] 0 0
Number of Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to 4 years
Primary outcome [3] 0 0
Number of AEs leading to discontinuation
Timepoint [3] 0 0
Up to 4 years
Primary outcome [4] 0 0
Number of laboratory test toxicity grade shifting from baseline
Timepoint [4] 0 0
Up to 4 years
Secondary outcome [1] 0 0
Best Overall Response
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
Up to 4 years
Secondary outcome [3] 0 0
Duration of Response
Timepoint [3] 0 0
Up to 4 years
Secondary outcome [4] 0 0
Maximum observed plasma concentration (Cmax)
Timepoint [4] 0 0
Up to 4 years
Secondary outcome [5] 0 0
Time of maximum observed plasma concentration (Tmax)
Timepoint [5] 0 0
Up to 4 years
Secondary outcome [6] 0 0
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Timepoint [6] 0 0
Up to 4 years
Secondary outcome [7] 0 0
Area under the concentration-time curve in one dosing interval (AUC(TAU))
Timepoint [7] 0 0
Up to 4 years
Secondary outcome [8] 0 0
Apparent terminal phase half-life (T-HALF)
Timepoint [8] 0 0
Up to 4 years
Secondary outcome [9] 0 0
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Timepoint [9] 0 0
Up to 4 years
Secondary outcome [10] 0 0
Apparent total body clearance, reported only for parent, not for metabolite (CLT/F)
Timepoint [10] 0 0
Up to 4 years
Secondary outcome [11] 0 0
Apparent volume of distribution of terminal phase, reported only for parent, not for metabolite (Vz/F)
Timepoint [11] 0 0
Up to 4 years
Secondary outcome [12] 0 0
Minimum observed concentration within a dosing interval (Cmin)
Timepoint [12] 0 0
Up to 4 years
Secondary outcome [13] 0 0
Concentration at the end of a dosing interval (Ctau)
Timepoint [13] 0 0
Up to 4 years
Secondary outcome [14] 0 0
Trough observed plasma concentration (this includes predose concentrations (C0) and concentrations at the end of dosing interval (Ctau)) (Ctrough)
Timepoint [14] 0 0
Up to 4 years
Secondary outcome [15] 0 0
Degree of Fluctuation or Fluctuation Index ([Cmax-Cmin)/Css-avg])
Timepoint [15] 0 0
Up to 4 years
Secondary outcome [16] 0 0
[Cmax - Cmin] / Cmin; to be calculated at steady-state (Swing)
Timepoint [16] 0 0
Up to 4 years
Secondary outcome [17] 0 0
Accumulation Index (AI) - Ratio of an exposure measure at steady-state to that after the first dose (exposure measure includes AUC(TAU), Cmax and Ctau)
Timepoint [17] 0 0
Up to 4 years
Secondary outcome [18] 0 0
Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (T-HALFeff)
Timepoint [18] 0 0
Up to 4 years
Secondary outcome [19] 0 0
Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax)
Timepoint [19] 0 0
Up to 4 years
Secondary outcome [20] 0 0
Ratio of metabolite AUC(0-T) to parent AUC(0-T), corrected for molecular weight (MR_AUC(0-T))
Timepoint [20] 0 0
Up to 4 years
Secondary outcome [21] 0 0
Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight (following single dose only) (MR_AUC(INF))
Timepoint [21] 0 0
Up to 4 years
Secondary outcome [22] 0 0
Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight (MR_AUC(TAU))
Timepoint [22] 0 0
Up to 4 years
Secondary outcome [23] 0 0
Electrocardiogram (ECG) QT (time of ventricular activity including both depolarization and repolarization) Interval
Timepoint [23] 0 0
Up to 4 years

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com



- 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
Minimum age
12 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Oregon
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
South Carolina
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
France
State/province [8] 0 0
Lyon Cedex 08
Country [9] 0 0
France
State/province [9] 0 0
Paris Cedex 5
Country [10] 0 0
France
State/province [10] 0 0
Villejuif
Country [11] 0 0
Spain
State/province [11] 0 0
Barcelona
Country [12] 0 0
Spain
State/province [12] 0 0
Madrid
Country [13] 0 0
Spain
State/province [13] 0 0
Pamplona
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Whitchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/show/NCT02419417
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02419417