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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 : February 27, 2023
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date  ICMJE May 29, 2020
First Posted Date  ICMJE June 11, 2020
Last Update Posted Date February 27, 2023
Actual Study Start Date  ICMJE June 22, 2020
Estimated Primary Completion Date August 27, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2022)
  • 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. ]
  • Dose-limiting toxicity (DLT) [ Time Frame: Up to 35 days ]
  • Non-tolerated dose (NTD) [ Time Frame: Up to 35 days ]
  • Maximum tolerated dose (MTD) [ Time Frame: Up to 35 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2020)
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2022)
  • Confirmed Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50) [ Time Frame: 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 ]
  • Duration of response (DOR) [ Time Frame: 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 ]
  • PSA Progression Free Survival (PFS) [ Time Frame: Up to approximately 4 years ]
  • Radiographic progression free survival (rPFS) [ Time Frame: Up to approximately 4 years ]
  • Overall survival (OS) [ Time Frame: 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 ]
  • Pharmacokinetics - Area under the plasma concentration time curve (AUC) [ Time Frame: Up to 35 days ]
  • Pharmacokinetics - Maximum plasma concentration (Cmax) [ Time Frame: Up to 35 days ]
  • Pharmacokinetics - Time to Cmax (Tmax) [ Time Frame: Up to 35 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2020)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Tolerability of CC-94676 in Participants With Metastatic Castration-Resistant Prostate Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostatic Neoplasms
Intervention  ICMJE Drug: CC-94676
Specified dose on specified days
Study Arms  ICMJE Experimental: Administration of CC-94676
Intervention: Drug: CC-94676
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 27, 2022)		 122
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2020)		 40
Estimated Study Completion Date  ICMJE February 27, 2025
Estimated Primary Completion Date August 27, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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 #.
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04428788
Other Study ID Numbers  ICMJE CC-94676-PCA-001
U1111-1251-9174 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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/
Current Responsible Party Celgene
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Celgene
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Celgene
Verification Date February 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP