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

March 29, 2024 updated by: Celgene

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

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

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Withdrawn
        • Local Institution - 118
    • California
      • Stanford, California, United States, 94305-5826
        • Recruiting
        • Stanford University
        • Contact:
          • Sandhya Srinivas, Site 116
          • Phone Number: 650-725-2078
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Not yet recruiting
        • Sibley Memorial Hospital
        • Contact:
          • Michael Carducci, Site 208
          • Phone Number: 410-614-3977
      • Washington, District of Columbia, United States, 20010
        • Not yet recruiting
        • MedStar Washington Hospital Center
        • Contact:
          • Suthee Rapisuwon, Site 122
    • Florida
      • Sarasota, Florida, United States, 34232
        • Recruiting
        • Florida Cancer Specialists
        • Contact:
          • Manish Patel, Site 103
          • Phone Number: 941-377-9993
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Withdrawn
        • Emory University.
      • Thomasville, Georgia, United States, 31792
        • Not yet recruiting
        • Lewis Hall Singletary Oncology Center
        • Contact:
          • Josh Simmons, Site 121
          • Phone Number: 229-551-8645
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • Withdrawn
        • University of Chicago
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins
        • Contact:
          • Michael Carducci, Site 108
          • Phone Number: 410-614-3977
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute
        • Contact:
          • Atish Choudhury, Site 104
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Cancer Center
        • Contact:
          • Zachery Reichert, Site 117
          • Phone Number: 815-353-5419
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • Start Midwest
        • Contact:
          • Nehal Lakhani, Site 102
          • Phone Number: 616-954-5554
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Dana Rathkopf, Site 105
          • Phone Number: 646-422-4379
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University
        • Contact:
          • Karie Runcie, Site 109
          • Phone Number: 212-305-8923
      • New York, New York, United States, 10029
        • Withdrawn
        • Mount Sinai Doctors Dermatology
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai - Icahn School of Medicine
        • Contact:
          • Bobby Liaw, Site 112
          • Phone Number: 212-604-6074
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Contact:
          • Andrew Armstrong, Site 106
          • Phone Number: 919-668-8797
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Lehigh Valley Health Network
        • Contact:
          • Paul Palyca, Site 120
          • Phone Number: 610-402-9543
      • Philadelphia, Pennsylvania, United States, 19104
        • Withdrawn
        • Abramson Cancer Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Abramson Cancer Center
        • Contact:
          • Vivek Narayan, Site 113
          • Phone Number: 215-360-0706
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • UT Southwestern
        • Contact:
          • Kevin Courtney, Site 107
          • Phone Number: 833-722-6237
      • Houston, Texas, United States, 77030
        • Recruiting
        • M.D. Anderson Cancer Center
        • Contact:
          • Ana Aparicio, Site 119
          • Phone Number: 832-312-6124
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • South Texas Accelerated Research Therapeutics (START)
        • Contact:
          • Drew Rasco, Site 101
          • Phone Number: 210-593-5250
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center
        • Contact:
          • Jessica Hawley, Site 115
          • Phone Number: 206-606-2284
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Carbone Cancer Center
        • Contact:
          • Hamid Emamekhoo, Site 111
          • Phone Number: 513-862-1400
      • Madison, Wisconsin, United States, 53705
        • Withdrawn
        • University of Wisconsin Carbone Cancer Center
      • Madison, Wisconsin, United States, 53792
        • Withdrawn
        • University of Wisconsin Carbone Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Administration of CC-94676, CC1083611, and CC1083610
Drug: CC-94676
Specified dose on specified days
Other Names:
  • BMS-986365
Drug: CC1083611
Specified dose on specified days
Other Names:
  • BMS-986409
Drug: CC1083610
Specified dose on specified days
Other Names:
  • BMS-986410

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose-limiting toxicity (DLT)
Time Frame: Up to 35 days
Up to 35 days
Non-tolerated dose (NTD)
Time Frame: Up to 35 days
Up to 35 days
Maximum tolerated dose (MTD)
Time Frame: Up to 35 days
Up to 35 days
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.
From the time of consent at screening until 28 days after thesubject discontinues study treatment.

Secondary Outcome Measures

Outcome Measure
Time Frame
Confirmed Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50)
Time Frame: Up to approximately 4 years
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
Up to approximately 4 years
Duration of response (DOR)
Time Frame: Up to approximately 4 years
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
Up to 6 months after treatment is discontinued
PSA Progression Free Survival (PFS)
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Radiographic progression free survival (rPFS)
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Overall survival (OS)
Time Frame: Up to approximately 4 years
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
Up to approximately 4 years
Pharmacokinetics - Area under the plasma concentration time curve (AUC)
Time Frame: Up to 35 days
Up to 35 days
Pharmacokinetics - Maximum plasma concentration (Cmax)
Time Frame: Up to 35 days
Up to 35 days
Pharmacokinetics - Time to Cmax (Tmax)
Time Frame: Up to 35 days
Up to 35 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2020

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 27, 2026

Study Registration Dates

First Submitted

May 29, 2020

First Submitted That Met QC Criteria

June 10, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-94676-PCA-001
  • U1111-1251-9174 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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/

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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