Metastatic Castration-resistant Prostate Cancer
Conditions
Keywords
Prostate Cancer, Castration-resistant prostate cancer, Adenocarcinoma of the prostate, Prostatic Neoplasms Castration-Resistant, Neoplasms
Brief summary
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.
Interventions
DRUGBMS-986460
Specified dose on specified days.
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant must have histologically or cytologically confirmed adenocarcinoma of the prostate. * Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. * Participant must have prostate specific antigen (PSA) of ≥ 2 ng/mL at Screening * Participant must have progressed on androgen deprivation therapy (ADT) and at least one prior secondary hormonal therapy approved for castration-resistant prostate cancer (CRPC)
Exclusion criteria
* Participant must not have history of brain metastases. * Participant must not have impaired cardiac function or clinically significant cardiac disease. * Participant must not have any significant medical condition, including active or uncontrolled infection, psychiatric illness, or the presence of laboratory abnormalities, which places the participant at unacceptable risk or prevent participation in the study based on Investigator assessment. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events (AEs) | Up to 112 weeks |
| Number of participants with serious adverse events (SAEs) | Up to 112 weeks |
| Number of participants with AEs meeting protocol defined dose limiting toxicity (DLT) criteria | Up to 28 days |
| Number of participants with AEs leading to study intervention discontinuation | Up to 104 weeks |
| Number of deaths | Up to 108 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Maximum concentration (Cmax) | Up to 13 weeks |
| Time of maximum concentration (Tmax) | Up to 13 weeks |
| Area under the plasma concentration-time curve (AUC) | Up to 13 weeks |
| Number of participants with a confirmed prostate specific antigen decline of ≥ 30% from baseline response rate | Up to 108 weeks |
| Number of participants with soft tissue response | Up to 108 weeks |
| Duration of response (DOR) | Up to 108 weeks |
Countries
Canada, France, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed