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Study of BMS-986158 in Subjects With Select Advanced Cancers (BET)

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ClinicalTrials.gov Identifier: NCT02419417
Recruitment Status : Recruiting
First Posted : April 17, 2015
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Advanced Tumors Drug: BMS-986158 Biological: Nivolumab Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 5, 2015
Estimated Primary Completion Date : December 2, 2021
Estimated Study Completion Date : December 3, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Monotherapy Treatment
Patients treated at various doses and schedules
Drug: BMS-986158
Specified dose on specified days

Experimental: Combination Therapy
Patients treated at selected doses and schdules
Drug: BMS-986158
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo




Primary Outcome Measures :
  1. Number of Adverse Events (AEs) [ Time Frame: Up to 4 years ]
  2. Number of Serious Adverse Events (SAEs) [ Time Frame: Up to 4 years ]
  3. Number of AEs leading to discontinuation [ Time Frame: Up to 4 years ]
  4. Number of laboratory test toxicity grade shifting from baseline [ Time Frame: Up to 4 years ]

Secondary Outcome Measures :
  1. Best Overall Response [ Time Frame: Up to 4 years ]
  2. Objective Response Rate (ORR) [ Time Frame: Up to 4 years ]
  3. Duration of Response [ Time Frame: Up to 4 years ]
  4. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 4 years ]
  5. Time of maximum observed plasma concentration (Tmax) [ Time Frame: Up to 4 years ]
  6. 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 ]
  7. Area under the concentration-time curve in one dosing interval (AUC(TAU)) [ Time Frame: Up to 4 years ]
  8. Apparent terminal phase half-life (T-HALF) [ Time Frame: Up to 4 years ]
  9. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) [ Time Frame: Up to 4 years ]
  10. Apparent total body clearance, reported only for parent, not for metabolite (CLT/F) [ Time Frame: Up to 4 years ]
  11. Apparent volume of distribution of terminal phase, reported only for parent, not for metabolite (Vz/F) [ Time Frame: Up to 4 years ]
  12. Minimum observed concentration within a dosing interval (Cmin) [ Time Frame: Up to 4 years ]
  13. Concentration at the end of a dosing interval (Ctau) [ Time Frame: Up to 4 years ]
  14. 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 ]
  15. Degree of Fluctuation or Fluctuation Index ([Cmax-Cmin)/Css-avg]) [ Time Frame: Up to 4 years ]
  16. [Cmax - Cmin] / Cmin; to be calculated at steady-state (Swing) [ Time Frame: Up to 4 years ]
  17. Accumulation Index (AI) [ Time Frame: Up to 4 years ]
    Ratio of an exposure measure at steady-state to that after the first dose (exposure measure includes AUC(TAU), Cmax and Ctau)

  18. Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (T-HALFeff) [ Time Frame: Up to 4 years ]
  19. Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax) [ Time Frame: Up to 4 years ]
  20. 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 ]
  21. 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 ]
  22. Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight (MR_AUC(TAU)) [ Time Frame: Up to 4 years ]
  23. Electrocardiogram (ECG) QT (time of ventricular activity including both depolarization and repolarization) Interval [ Time Frame: Up to 4 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Males and females 12 years old or older
  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02419417


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
United States, California
City Of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Mihaela Cristea, Site 0004    626-359-8111      
United States, Colorado
University Of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Jennifer Diamond, Site 0020    720-848-0643      
United States, Oregon
Local Institution Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Site 0023         
United States, South Carolina
Institute for Translational Oncology Research-ITOR Recruiting
Greenville, South Carolina, United States, 29605
Contact: William Edenfield, Site 0001    864-679-3926      
Australia, Victoria
Local Institution Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Site 0006         
Belgium
Local Institution Withdrawn
Brussels, Belgium, 1000
Local Institution Not yet recruiting
Bruxelles, Belgium, 1200
Contact: Site 0031         
Local Institution Not yet recruiting
Gent, Belgium, 9000
Contact: Site 0007         
Canada, Ontario
The Ottawa Hospital Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: John Hilton, Site 0003    613737770073955      
Local Institution Withdrawn
Toronto, Ontario, Canada, M5G 1X6
France
Local Institution Not yet recruiting
Lyon Cedex 08, France, 69373
Contact: Site 0025         
Local Institution Recruiting
Villejuif, France, 94800
Contact: Site 0024         
Netherlands
Local Institution Not yet recruiting
Maastrict, Netherlands, 6229 HX
Contact: Site 0011         
Local Institution Not yet recruiting
Rotterdam, Netherlands, 3015 CE
Contact: Site 0010         
Spain
Local Institution Not yet recruiting
Barcelona, Spain, 08035
Contact: Site 0030         
Local Institution Not yet recruiting
Madrid, Spain, 28050
Contact: Site 0019         
Local Institution Not yet recruiting
Pamplona, Spain, 31008
Contact: Site 0018         
United Kingdom
Local Institution Not yet recruiting
London, Greater London, United Kingdom, EC1M 6BQ
Contact: Site 0021         
Local Institution Not yet recruiting
London, Greater London, United Kingdom, NW1 2PG
Contact: Site 0013         
Local Institution Not yet recruiting
Manchester, Greater Manchester, United Kingdom, M20 4BX
Contact: Site 0014         
Local Institution Withdrawn
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Local Institution Not yet recruiting
Whitchurch, United Kingdom, CF14 2TL
Contact: Site 0032         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02419417     History of Changes
Other Study ID Numbers: CA011-001
2015-000324-29 ( EudraCT Number )
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Nivolumab
Antineoplastic Agents