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

Sponsor
Celgene (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04428788
Collaborator
(none)
122
Enrollment
31
Locations
1
Arm
56.2
Anticipated Duration (Months)
3.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
122 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 :
Jun 22, 2020
Anticipated Primary Completion Date :
Aug 27, 2023
Anticipated Study Completion Date :
Feb 27, 2025

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 [From the time of consent at screening until 28 days after the subject discontinues study treatment.]

  2. Dose-limiting toxicity (DLT) [Up to 35 days]

  3. Non-tolerated dose (NTD) [Up to 35 days]

  4. Maximum tolerated dose (MTD) [Up to 35 days]

Secondary Outcome Measures

  1. Confirmed Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50) [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) [Up to approximately 4 years]

  3. Duration of response (DOR) [Up to approximately 4 years]

  4. Proportion of participants alive and not progressed at 6 months [Up to 6 months after treatment is discontinued]

  5. PSA Progression Free Survival (PFS) [Up to approximately 4 years]

  6. Radiographic progression free survival (rPFS) [Up to approximately 4 years]

  7. Overall survival (OS) [Up to approximately 4 years]

  8. Overall Survival (OS) rate summarized using the Kaplan-Meier method for the treated population [Up to approximately 4 years]

  9. Pharmacokinetics - Area under the plasma concentration time curve (AUC) [Up to 35 days]

  10. Pharmacokinetics - Maximum plasma concentration (Cmax) [Up to 35 days]

  11. Pharmacokinetics - Time to Cmax (Tmax) [Up to 35 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 UAB Birmingham Alabama United States 35249
2 Stanford University Stanford California United States 94305-5826
3 M.D. Anderson Cancer Center Orlando Florida United States 32806
4 Florida Cancer Specialists Sarasota Florida United States 34232
5 Florida Cancer Specialists Sarasota Florida United States 34232
6 Emory University. Atlanta Georgia United States 30303
7 University of Chicago Chicago Illinois United States 60637-1470
8 Johns Hopkins Baltimore Maryland United States 21287
9 Johns Hopkins Baltimore Maryland United States 21287
10 Dana Farber Cancer Institute Boston Massachusetts United States 02215
11 Dana Farber Cancer Institute Boston Massachusetts United States 02215
12 University Of Michigan Cancer Center Ann Arbor Michigan United States 48109
13 START Midwest Grand Rapids Michigan United States 49546
14 START Midwest Grand Rapids Michigan United States 49546
15 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
16 Mount Sinai - Icahn School of Medicine New York New York United States 10029
17 Mount Sinai Doctors Dermatology New York New York United States 10029
18 Columbia University New York New York United States 10032
19 Memorial Sloan Kettering cancer Center New York New York United States 10065
20 Duke University Medical Center Durham North Carolina United States 27710
21 Duke University Medical Center Durham North Carolina United States 27710
22 Abramson Cancer Center Philadelphia Pennsylvania United States 19104
23 Abramson Cancer Center Philadelphia Pennsylvania United States 19104
24 UT Southwestern Dallas Texas United States 75235
25 Ut Southwestern Dallas Texas United States 75235
26 South Texas Accelerated Research Therapeutics San Antonio Texas United States 78229
27 South Texas Accelerated Research Therapeutics San Antonio Texas United States 78229
28 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109
29 University of Wisconsin Carbone Cancer Center Madison Wisconsin United States 53705
30 University of Wisconsin Carbone Cancer Center Madison Wisconsin United States 53792
31 University of Wisconsin Carbone Cancer Center Madison Wisconsin United States 53792

Sponsors and Collaborators

  • Celgene

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Celgene
ClinicalTrials.gov Identifier:
NCT04428788
Other Study ID Numbers:
  • CC-94676-PCA-001
  • U1111-1251-9174
First Posted:
Jun 11, 2020
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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

Study Results

No Results Posted as of Aug 18, 2022