Status:
COMPLETED
Study to Evaluate the Safety and Tolerability of CC-94676 in Participants With Metastatic Castration-Resistant Prostate Cancer
Lead Sponsor:
Celgene
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety, tolerability and preliminary efficacy of CC-94676 in men with progressive metastatic castration resistant prostate cancer.
Eligibility Criteria
Inclusion
- Must have histologically or cytologically confirmed adenocarcinoma of the prostate
- Progressed on androgen deprivation therapy (ADT) and at least one prior secondary hormonal therapy approved for castration-resistant prostate cancer (CRPC)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Exclusion
- Prior treatment with an androgen receptor (AR) degrader
- Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 1 year prior to the first dose of IP
- Clinically significant venous thromboembolism within 3 months prior to the first dose of IP
- Any significant medical condition, such as uncontrolled infection, laboratory abnormality, or psychiatric illness
- Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
June 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2025
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT04428788
Start Date
June 22 2020
End Date
October 28 2025
Last Update
December 22 2025
Active Locations (19)
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1
Local Institution - 116
Stanford, California, United States, 94305-5826
2
Local Institution - 122
Washington D.C., District of Columbia, United States, 20010
3
Local Institution - 103
Sarasota, Florida, United States, 34232
4
Local Institution - 121
Thomasville, Georgia, United States, 31792