Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CC-94676 in Subjects With Metastatic Castration-Resistant Prostate Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 40
Summary
- Conditions
- Prostatic Neoplasms
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
Study CC-94676-PCA-001 is a first-in-human dose finding study to determine the safety, tolerability, PK, PD, and preliminary efficacy of CC-94676 in subjects with mCRPC who have progressed on ADT and at least one prior secondary hormonal therapy approved for CRPC (eg, abiraterone, enzalutamide, apal...
Study CC-94676-PCA-001 is a first-in-human dose finding study to determine the safety, tolerability, PK, PD, and preliminary efficacy of CC-94676 in subjects with mCRPC who have progressed on ADT and at least one prior secondary hormonal therapy approved for CRPC (eg, abiraterone, enzalutamide, apalutamide, or darolutamide). The dose escalation will evaluate the safety and tolerability of escalating doses of CC-94676 in mCRCP subjects to determine the MTD of CC-94676. The dose expansion will further evaluate the safety and preliminary efficacy of CC-94676 administered at or below MTD in subjects with mCRPC.
Tracking Information
- NCT #
- NCT04428788
- Collaborators
- Not Provided
- Investigators
- Study Director: Marie Nguyen, MD Celgene
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