Study to Evaluate the Safety and Tolerability of CC-94676 in Participants With Metastatic Castration-Resistant Prostate Cancer

Prostatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04428788
• Other study ID #: CC-94676-PCA-001
• Secondary ID: U1111-1251-9174
• Status: Recruiting
• Phase: Phase 1
• Start date: June 22, 2020
• Est. completion date: December 27, 2026

Study information

• Verified date: June 2024
• Source: Celgene
• Contact: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 27, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Neoplasms
• Prostatic Neoplasms

Intervention

Drug:
• CC-94676
Specified dose on specified days
• CC1083611
Specified dose on specified days
• CC1083610
Specified dose on specified days

Locations

Country	Name	City	State
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	University Of Michigan Cancer Center	Ann Arbor	Michigan
United States	Emory University.	Atlanta	Georgia
United States	Local Institution - 108	Baltimore	Maryland
United States	Local Institution - 118	Birmingham	Alabama
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	University Of Chicago	Chicago	Illinois
United States	Ut Southwestern	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	START Midwest	Grand Rapids	Michigan
United States	M.D. Anderson Cancer Center	Houston	Texas
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin
United States	Columbia University	New York	New York
United States	Memorial Sloan Kettering cancer Center	New York	New York
United States	Mount Sinai - Icahn School of Medicine	New York	New York
United States	Mount Sinai Doctors Dermatology	New York	New York
United States	Abramson Cancer Center	Philadelphia	Pennsylvania
United States	Abramson Cancer Center	Philadelphia	Pennsylvania
United States	South Texas Accelerated Research Therapeutics (START)	San Antonio	Texas
United States	Florida Cancer Specialists - East	Sarasota	Florida
United States	Fred Hutchinson Cancer Center	Seattle	Washington
United States	Stanford University	Stanford	California
United States	Lewis Hall Singletary Oncology Center	Thomasville	Georgia
United States	Local Institution - 208	Washington	District of Columbia
United States	Medstar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Dose-limiting toxicity (DLT)		Up to 35 days
Primary	Non-tolerated dose (NTD)		Up to 35 days
Primary	Maximum tolerated dose (MTD)		Up to 35 days
Secondary	Confirmed Prostate Specific Antigen (PSA) decline of = 50% from baseline (PSA50)		Up to approximately 4 years
Secondary	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
Secondary	Duration of response (DOR)		Up to approximately 4 years
Secondary	Proportion of participants alive and not progressed at 6 months		Up to 6 months after treatment is discontinued
Secondary	PSA Progression Free Survival (PFS)		Up to approximately 4 years
Secondary	Radiographic progression free survival (rPFS)		Up to approximately 4 years
Secondary	Overall survival (OS)		Up to approximately 4 years
Secondary	Overall Survival (OS) rate summarized using the Kaplan-Meier method for the treated population		Up to approximately 4 years
Secondary	Pharmacokinetics - Area under the plasma concentration time curve (AUC)		Up to 35 days
Secondary	Pharmacokinetics - Maximum plasma concentration (Cmax)		Up to 35 days
Secondary	Pharmacokinetics - Time to Cmax (Tmax)		Up to 35 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting