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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04428788
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : April 1, 2024
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Description
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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 Intervention/treatment Phase
Prostatic Neoplasms Drug: CC-94676 Drug: CC1083611 Drug: CC1083610 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 30, 2025
Estimated Study Completion Date : December 27, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Administration of CC-94676, CC1083611, and CC1083610 Drug: CC-94676
Specified dose on specified days
Other Name: BMS-986365

Drug: CC1083611
Specified dose on specified days
Other Name: BMS-986409

Drug: CC1083610
Specified dose on specified days
Other Name: BMS-986410


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

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

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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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
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Sponsors and Collaborators
Celgene
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT04428788    
Other Study ID Numbers: CC-94676-PCA-001
U1111-1251-9174 ( Other Identifier: WHO )
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: April 1, 2024
Last Verified: March 2024
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/

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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:
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Prostatic Neoplasms
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases