Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02419417
Ethics application status
Date submitted
2/04/2015
Date registered
17/04/2015
Date last updated
16/06/2022

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
Treatment: Other - 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

Treatment: Other: Nivolumab
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Experiencing Adverse Events
Timepoint [1] 0 0
From first dose to 30 days following last dose (up to approximately 29 months)
Primary outcome [2] 0 0
Number of Participants With Abnormal Hepatic Test Values
Timepoint [2] 0 0
From first dose to 30 days following last dose (up to approximately 29 months)
Secondary outcome [1] 0 0
Best Overall Response (BOR)
Timepoint [1] 0 0
From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months)
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months)
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
From date of first response to date of first objectively documented disease progression or death (up to approximately 42 weeks)
Secondary outcome [4] 0 0
Progression Free Survival (PFS)
Timepoint [4] 0 0
From first dose to date of first objectively documented disease progression or death (up to approximately 28 months)
Secondary outcome [5] 0 0
Progression Free Survival Rate (PFSR)
Timepoint [5] 0 0
From first dose to 12 weeks, to 24 weeks, and to 48 weeks after first dose
Secondary outcome [6] 0 0
Maximum Observed Plasma Concentration (Cmax) - Single Dose Administration
Timepoint [6] 0 0
From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Secondary outcome [7] 0 0
Time of Maximum Observed Plasma Concentration (Tmax) - Single Dose Administration
Timepoint [7] 0 0
From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Secondary outcome [8] 0 0
Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose Administration
Timepoint [8] 0 0
From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Secondary outcome [9] 0 0
Apparent Terminal Phase Half-Life (T-HALF) - Single Dose Administration
Timepoint [9] 0 0
From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Secondary outcome [10] 0 0
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose Administration
Timepoint [10] 0 0
From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Secondary outcome [11] 0 0
Apparent Total Body Clearance (CLT/F) - Single Dose Administration
Timepoint [11] 0 0
From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Secondary outcome [12] 0 0
Apparent Volume of Distribution of Terminal Phase (Vz/F) - Single Dose Administration
Timepoint [12] 0 0
From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Secondary outcome [13] 0 0
Maximum Observed Plasma Concentration (Cmax) - Multiple Dose Administration
Timepoint [13] 0 0
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)
Secondary outcome [14] 0 0
Time to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose Administration
Timepoint [14] 0 0
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)
Secondary outcome [15] 0 0
Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose Administration
Timepoint [15] 0 0
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)
Secondary outcome [16] 0 0
Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose Administration
Timepoint [16] 0 0
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)
Secondary outcome [17] 0 0
Minimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose Administration
Timepoint [17] 0 0
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)
Secondary outcome [18] 0 0
Concentration at the End of Dosing Interval (C24) - Multiple Dose Administration
Timepoint [18] 0 0
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)
Secondary outcome [19] 0 0
Trough Observed Plasma Concentration (Ctrough) - Multiple Dose Administration
Timepoint [19] 0 0
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)
Secondary outcome [20] 0 0
Accumulation Index (AI) - Multiple Dose Administration
Timepoint [20] 0 0
Cycle 2 Day 5 (Schedule A) or Cycle 2 Day 14 (Schedule B) or Cycle 2 Day 7 (Schedule C)
Secondary outcome [21] 0 0
Effective Elimination Half-Life (Effective T-HALF) - Multiple Dose Administration
Timepoint [21] 0 0
Cycle 2 Day 5 (Schedule A) or Cycle 2 Day 14 (Schedule B) or Cycle 2 Day 7 (Schedule C)
Secondary outcome [22] 0 0
Ratio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose Administration
Timepoint [22] 0 0
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)
Secondary outcome [23] 0 0
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
Timepoint [23] 0 0
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)
Secondary outcome [24] 0 0
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
Timepoint [24] 0 0
Cycle 1 Day 1
Secondary outcome [25] 0 0
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
Timepoint [25] 0 0
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)
Secondary outcome [26] 0 0
Change From Baseline in Electrocardiogram Parameter QTcF
Timepoint [26] 0 0
From Cycle 1 Day 1 to last dosing day in Cycle 2 (C2D8 for Schedule A, C2D14 for Schedule B, C2D7 for Schedule C).

Eligibility
Key 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
Minimum age
12 Years
Maximum age
No limit
Sex
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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/03/2021
Sample size
Target
Accrual to date
Final
83
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
Villejuif
Country [10] 0 0
Spain
State/province [10] 0 0
Barcelona
Country [11] 0 0
Spain
State/province [11] 0 0
Madrid
Country [12] 0 0
Spain
State/province [12] 0 0
Pamplona

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/study/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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

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