Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CC-94676 in Subjects With Metastatic Castration-Resistant Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT04428788|
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : May 6, 2021
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms||Drug: CC-94676||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Multi-center, Open-label, Dose Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cc-94676 in Subjects With Metastatic Castration-resistant Prostate Cancer|
|Actual Study Start Date :||June 22, 2020|
|Estimated Primary Completion Date :||June 28, 2022|
|Estimated Study Completion Date :||June 28, 2022|
Experimental: Administration of CC-94676
Escalating doses of CC-94676 administered orally (tablets) once daily.
- Adverse Events (AEs) [ Time Frame: From the time of consent at screening until 28 days after the subject discontinues study treatment. ]Type, frequency, seriousness, severity and relationship of AEs to CC-94676.
- Dose-limiting Toxicities (DLTs) [ Time Frame: Up to 35 days ]Number of subjects with a DLT.
- Non-Tolerated Dose (NTD) [ Time Frame: Up to 35 days ]The dose of CC-94676 associated with unacceptable safety and tolerability.
- Maximum Tolerated Dose (MTD) [ Time Frame: Up to 35 days ]The highest dose of CC-94676 associated with acceptable safety and tolerability.
- Confirmed Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50) [ Time Frame: Up to approximately 4 years ]is defined as a ≥ 50% reduction in PSA from baseline to the lowest postbaseline PSA value and required confirmation by a consecutive assessment at least 3 weeks later (PSA50).
- Objective soft tissue response [ Time Frame: Up to approximately 4 years ]The proportion of subjects who achieve a best response of partial response or better (PR or CR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3).
- Duration of response (DOR) [ Time Frame: Up to approximately 4 years ]is defined as the time from the earliest date of documented soft tissue response (PR or CR based on PCWG3) to the first documented soft tissue disease progression or death, whichever occurs first.
- Proportion of subjects alive and not progressed at 6 months [ Time Frame: Up to 6 months after treatment is discontinued ]The proportion of subjects alive and who have not progressed at 6 months follow-up with progression defined by PCWG3.
- PSA Progression Free Survival (PFS) [ Time Frame: Up to approximately 4 years ]PSA PFS will be calculated for all treated subjects as, after a decline from baseline, the time from the first dose of CC-94676 to the first PSA increase that is ≥ 25% and a ≥ 2 ng/mL above the nadir, and which is confirmed by a second value ≥ 3 weeks later. When there is no decline from baseline, then PSA progression is ≥ 25% increase and a ≥ 2 ng/mL increase from baseline beyond 12 weeks.
- Radiographic progression free survival (rPFS) [ Time Frame: Up to approximately 4 years ]The time from the first dose of CC-94676 to the first objective evidence of radiographic progression or death from any cause, whichever occurs first.
- Overall survival (OS) [ Time Frame: Up to approximately 4 years ]OS is the time from the first dose of CC-94676 to death from any cause.
- Overall Survival (OS) rate [ Time Frame: Up to approximately 4 years ]will be summarized using the Kaplan-Meier method for the treated population.
- Pharmacokinetics - AUC [ Time Frame: Up to 35 days ]Area under the plasma concentration time curve
- Pharmacokinetics - Cmax [ Time Frame: Up to 35 days ]Maximum plasma concentration
- Pharmacokinetics - Tmax [ Time Frame: Up to 35 days ]Time to Cmax
- Pharmacokinetics - t1/2 [ Time Frame: Up to 35 days ]Terminal half-life
- Pharmacokinetics - CL/F [ Time Frame: Up to 35 days ]Apparent total clearance of the drug from plasma after oral administration
- Pharmacokinetics - Vz/F [ Time Frame: Up to 35 days ]Apparent volume of distribution during terminal phase after oral administration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04428788
|Contact: Associate Director Clinical Trial Disclosurefirstname.lastname@example.org|
|United States, Florida|
|Florida Cancer Specialists||Recruiting|
|Sarasota, Florida, United States, 34232|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|United States, Michigan|
|Grand Rapids, Michigan, United States, 49546|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10021|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|United States, Texas|
|South Texas Accelerated Research Therapeutics||Recruiting|
|San Antonio, Texas, United States, 78229|
|Study Director:||Marie Nguyen, MD||Celgene|