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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
131
Local Institution - 116
Stanford, California, United States
Local Institution - 122
Washington D.C., District of Columbia, United States
Number of participants with adverse events (AEs) evaluated using the NCI CTCAE v5.0 criteria
Time frame: From the time of consent at screening until 28 days after thesubject discontinues study treatment.
Dose-limiting toxicity (DLT)
Time frame: Up to 35 days
Non-tolerated dose (NTD)
Time frame: Up to 35 days
Maximum tolerated dose (MTD)
Time frame: Up to 35 days
Confirmed Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50)
Time frame: Up to approximately 4 years
Objective soft tissue response defined by complete response (CR) or partial response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
Time frame: Up to approximately 4 years
Duration of response (DOR)
Time frame: Up to approximately 4 years
Proportion of participants alive and not progressed at 6 months
Time frame: Up to 6 months after treatment is discontinued
PSA Progression Free Survival (PFS)
Time frame: Up to approximately 4 years
Radiographic progression free survival (rPFS)
Time frame: Up to approximately 4 years
Overall survival (OS)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Local Institution - 103
Sarasota, Florida, United States
Local Institution - 121
Thomasville, Georgia, United States
Local Institution - 108
Baltimore, Maryland, United States
Local Institution - 104
Boston, Massachusetts, United States
Local Institution - 117
Ann Arbor, Michigan, United States
Local Institution - 102
Grand Rapids, Michigan, United States
Local Institution - 112
New York, New York, United States
Local Institution - 109
New York, New York, United States
...and 9 more locations
Time frame: Up to approximately 4 years
Overall Survival (OS) rate summarized using the Kaplan-Meier method for the treated population
Time frame: Up to approximately 4 years
Pharmacokinetics - Area under the plasma concentration time curve (AUC)
Time frame: Up to 35 days
Pharmacokinetics - Maximum plasma concentration (Cmax)
Time frame: Up to 35 days
Pharmacokinetics - Time to Cmax (Tmax)
Time frame: Up to 35 days