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

  • Clinicaltrials.gov identifier

    NCT04428788

  • Recruitment Status

    Recruiting

  • First Posted

    June 11, 2020

  • Last update posted

    May 5, 2022

Study Description

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.

  • Condition or Disease:Prostatic Neoplasms
  • Intervention/Treatment: Drug: CC-94676
  • Phase: Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 70 participants
  • Intervention Model: Sequential Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Study to Evaluate the Safety and Tolerability of CC-94676 in Participants With Metastatic Castration-Resistant Prostate Cancer
  • Actual Study Start Date: June 2020
  • Estimated Primary Completion Date: March 2023
  • Estimated Study Completion Date: October 2024

Arms and interventions

Arm Intervention/treatment
Experimental: Administration of CC-94676
Drug: CC-94676
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. 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 the subject discontinues study treatment. ]
  • 2. Dose-limiting toxicity (DLT) [ Time Frame: Up to 35 days ]
  • 3. Non-tolerated dose (NTD) [ Time Frame: Up to 35 days ]
  • 4. Maximum tolerated dose (MTD) [ Time Frame: Up to 35 days ]
  • Secondary Outcome Measures: 1. Confirmed Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50) [ Time Frame: Up to approximately 4 years ]
  • 2. 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 ]
  • 3. Duration of response (DOR) [ Time Frame: Up to approximately 4 years ]
  • 4. Proportion of participants alive and not progressed at 6 months [ Time Frame: Up to 6 months after treatment is discontinued ]
  • 5. PSA Progression Free Survival (PFS) [ Time Frame: Up to approximately 4 years ]
  • 6. Radiographic progression free survival (rPFS) [ Time Frame: Up to approximately 4 years ]
  • 7. Overall survival (OS) [ Time Frame: Up to approximately 4 years ]
  • 8. Overall Survival (OS) rate summarized using the Kaplan-Meier method for the treated population [ Time Frame: Up to approximately 4 years ]
  • 9. Pharmacokinetics - Area under the plasma concentration time curve (AUC) [ Time Frame: Up to 35 days ]
  • 10. Pharmacokinetics - Maximum plasma concentration (Cmax) [ Time Frame: Up to 35 days ]
  • 11. Pharmacokinetics - Time to Cmax (Tmax) [ Time Frame: Up to 35 days ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Male
  • Accepts Healthy Volunteers: No

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com 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 degrader Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment Clinically significant venous thromboembolism (VTE) within 3 months Any significant medical condition, such as uncontrolled infection, laboratory abnormality, or psychiatric illness Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain the NCT# and Site #.

Locations

United States, Florida
Florida Cancer Specialists
Sarasota

United States, Florida
Florida Cancer Specialists
Sarasota

United States, Illinois
University of Chicago
Chicago

United States, Maryland
Johns Hopkins
Baltimore

United States, Massachusetts
Dana Farber Cancer Institute
Boston

United States, Massachusetts
Dana Farber Cancer Institute
Boston

United States, Michigan
START Midwest
Grand Rapids

United States, Michigan
START Midwest
Grand Rapids

United States, New York
Memorial Sloan-Kettering Cancer Center
New York

United States, New York
Memorial Sloan-Kettering Cancer Center
New York

United States, North Carolina
Duke University Medical Center
Durham

United States, Texas
UT Southwestern
Dallas

United States, Texas
South Texas Accelerated Research Therapeutics
San Antonio

United States, Texas
South Texas Accelerated Research Therapeutics
San Antonio

Sponsors and Collaborators

Celgene

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT04428788 History of Changes
  • Other Study ID Numbers: CC-94676-PCA-001, U1111-1251-9174
  • First Posted: June 11, 2020 Key Record Dates
  • Last Update Posted: May 5, 2022
  • Last Verified: April 2022
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Yes
  • Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code
  • Time Frame: See Plan Description
  • Access Criteria: See Plan Description
  • URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: Prostate Cancer
    CC-94676
    Castration-resistant prostate cancer
    Adenocarcinoma of the prostate
    Prostatic Neoplasms Castration-Resistant
    Neoplasms
  • Additional relevant MeSH terms: Prostatic Neoplasms
    Neoplasms
    Genital Neoplasms, Male
    Urogenital Neoplasms
    Neoplasms by Site
    Prostatic Diseases