Spots Global Cancer Trial Database for Study to Evaluate Safety and Tolerability of CC-91633 (BMS-986397) in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-Risk Myelodysplastic Syndromes
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Trial Identification
Brief Title: Study to Evaluate Safety and Tolerability of CC-91633 (BMS-986397) in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-Risk Myelodysplastic Syndromes
Official Title: A Phase 1, Open-label, Dose-finding Study of CC-91633 (BMS-986397) in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-Risk Myelodysplastic Syndromes
Study ID: NCT04951778
Interventions
Study Description
Brief Summary: Study CC-91633-AML-001 is a Phase 1, open-label, dose escalation and expansion, first-in-human (FIH) clinical study of CC-91633 (BMS-986397) in participants with relapsed or refractory acute myeloid leukemia (R/R AML) or in participants with relapsed or refractory higher-risk myelodysplastic syndromes (R/R HR-MDS). The Dose Escalation part (Part A) of the study will enroll participants with R/R AML and R/R HR-MDS and will evaluate the safety and tolerability of escalating doses of CC-91633 (BMS-986397), administered orally, and determine the maximum tolerated dose (MTD) or preliminary recommended Phase 2 dose (RP2D) and schedule. Throughout the study, final decisions on dose escalation/de-escalation will be made by the safety review committee (SRC). Approximately 40 participants may be enrolled in Part A of the study. The expansion part (Part B) will confirm tolerability of the selected doses and schedules and evaluate whether efficacy is in a range that warrants further clinical development. Separate expansion cohorts for participants with R/R AML and R/R HR-MDS may enroll approximately 20 to 40 response evaluable participants per cohort. Parts A and B will consist of 3 periods: Screening, Treatment, and Follow-up.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution - 111, Gilbert, Arizona, United States
Local Institution - 103, La Jolla, California, United States
Northwestern University School Of Medicine, Chicago, Illinois, United States
Local Institution - 110, Chicago, Illinois, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Washington Univ School of Medicine Siteman Cancer Center, Saint Louis, Missouri, United States
Local Institution - 102, Columbus, Ohio, United States
Local Institution - 108, Philadelphia, Pennsylvania, United States
The University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Local Institution - 109, Seattle, Washington, United States
Local Institution - 604, Adelaide, South Australia, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Monash Health, Clayton, Victoria, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Local Institution - 603, Melbourne, Victoria, Australia
St Vincent's Hospital, Melbourne, Victoria, Australia
Local Institution - 203, Vancouver, British Columbia, Canada
Local Institution - 201, Ottawa, Ontario, Canada
Local Institution - 202, Toronto, Ontario, Canada
Vall d Hebron University Hospital, Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Local Institution - 303, Madrid, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Local Institution - 504, Manchester, Greater Manchester, United Kingdom
Local Institution - 502, London, London, City Of, United Kingdom
Local Institution - 503, Leeds, , United Kingdom
Local Institution - 505, London, , United Kingdom
Local Institution - 501, Oxford, , United Kingdom
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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