Study to Evaluate the Safety and Tolerability of CC-94676 in Participants With Metastatic Castration-Resistant Prostate Cancer
- Conditions
- Prostatic Neoplasms
- Interventions
- Registration Number
- NCT04428788
- Lead Sponsor
- Celgene
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 250
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Administration of CC-94676, CC1083611, and CC1083610 CC-94676 - Administration of CC-94676, CC1083611, and CC1083610 CC1083611 - Administration of CC-94676, CC1083611, and CC1083610 CC1083610 -
- Primary Outcome Measures
Name Time Method Non-tolerated dose (NTD) Up to 35 days Maximum tolerated dose (MTD) Up to 35 days Number of participants with adverse events (AEs) evaluated using the NCI CTCAE v5.0 criteria From the time of consent at screening until 28 days after thesubject discontinues study treatment. Dose-limiting toxicity (DLT) Up to 35 days
- Secondary Outcome Measures
Name Time Method Overall survival (OS) 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) Up to approximately 4 years Proportion of participants alive and not progressed at 6 months Up to 6 months after treatment is discontinued PSA Progression Free Survival (PFS) Up to approximately 4 years Confirmed Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50) Up to approximately 4 years Pharmacokinetics - Area under the plasma concentration time curve (AUC) Up to 35 days Duration of response (DOR) Up to approximately 4 years Radiographic progression free survival (rPFS) Up to approximately 4 years Pharmacokinetics - Maximum plasma concentration (Cmax) Up to 35 days Pharmacokinetics - Time to Cmax (Tmax) Up to 35 days Overall Survival (OS) rate summarized using the Kaplan-Meier method for the treated population Up to approximately 4 years
Trial Locations
- Locations (19)
Local Institution - 116
🇺🇸Stanford, California, United States
Local Institution - 122
🇺🇸Washington, District of Columbia, United States
Local Institution - 103
🇺🇸Sarasota, Florida, United States
Local Institution - 121
🇺🇸Thomasville, Georgia, 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
Local Institution - 105
🇺🇸New York, New York, United States
Local Institution - 106
🇺🇸Durham, North Carolina, United States
Local Institution - 120
🇺🇸Allentown, Pennsylvania, United States
Local Institution - 113
🇺🇸Philadelphia, Pennsylvania, United States
Local Institution - 107
🇺🇸Dallas, Texas, United States
Local Institution - 119
🇺🇸Houston, Texas, United States
Local Institution - 101
🇺🇸San Antonio, Texas, United States
Local Institution - 115
🇺🇸Seattle, Washington, United States
Local Institution - 111
🇺🇸Madison, Wisconsin, United States
Local Institution - 108
🇺🇸Baltimore, Maryland, United States