The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of BMS-986460 in men with Metastatic Castration-resistant Prostate Cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Specified dose on specified days.
Stanford Cancer Center
Palo Alto, California, United States
RECRUITINGFlorida Cancer Specialists Sarasota Drug Development Unit
Sarasota, Florida, United States
RECRUITINGDana-Farber Cancer Institute
Number of participants with adverse events (AEs)
Time frame: Up to 112 weeks
Number of participants with serious adverse events (SAEs)
Time frame: Up to 112 weeks
Number of participants with AEs meeting protocol defined dose limiting toxicity (DLT) criteria
Time frame: Up to 28 days
Number of participants with AEs leading to study intervention discontinuation
Time frame: Up to 104 weeks
Number of deaths
Time frame: Up to 108 weeks
Maximum concentration (Cmax)
Time frame: Up to 13 weeks
Time of maximum concentration (Tmax)
Time frame: Up to 13 weeks
Area under the plasma concentration-time curve (AUC)
Time frame: Up to 13 weeks
Number of participants with a confirmed prostate specific antigen decline of ≥ 30% from baseline response rate
Time frame: Up to 108 weeks
Number of participants with soft tissue response
Time frame: Up to 108 weeks
Duration of response (DOR)
Time frame: Up to 108 weeks
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
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CONTACT
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Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGDuke Cancer Institute
Durham, North Carolina, United States
RECRUITINGLocal Institution - 0006
San Antonio, Texas, United States
WITHDRAWNNEXT Oncology
San Antonio, Texas, United States
RECRUITINGFred Hutchinson Cancer Center
Seattle, Washington, United States
RECRUITING