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

Primary Purpose

Prostatic Neoplasms

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CC-94676
CC1083611
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Prostate Cancer, CC-94676, Castration-resistant prostate cancer, Adenocarcinoma of the prostate, Prostatic Neoplasms Castration-Resistant, Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • UAB
  • Stanford UniversityRecruiting
  • Medstar Washington Hospital Center
  • Sibley Memorial Hospital
  • M.D. Anderson Cancer CenterRecruiting
  • Florida Cancer SpecialistsRecruiting
  • Emory University.Recruiting
  • Lewis Hall Singletary Oncology Center
  • University Of Chicago
  • Johns HopkinsRecruiting
  • Dana Farber Cancer InstituteRecruiting
  • University Of Michigan Cancer CenterRecruiting
  • START MidwestRecruiting
  • Mount Sinai - Icahn School of MedicineRecruiting
  • Mount Sinai Doctors Dermatology
  • Columbia UniversityRecruiting
  • Memorial Sloan Kettering cancer CenterRecruiting
  • Duke University Medical CenterRecruiting
  • Lehigh Valley Health Network
  • Abramson Cancer Center
  • Abramson Cancer CenterRecruiting
  • Ut SouthwesternRecruiting
  • South Texas Accelerated Research Therapeutics (START)Recruiting
  • Fred Hutchinson.Cancer CenterRecruiting
  • University of Wisconsin Carbone Cancer Center
  • University of Wisconsin Carbone Cancer Center
  • University of Wisconsin Carbone Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Administration of CC-94676 and CC1083611

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with adverse events (AEs) evaluated using the NCI CTCAE v5.0 criteria
Dose-limiting toxicity (DLT)
Non-tolerated dose (NTD)
Maximum tolerated dose (MTD)

Secondary Outcome Measures

Confirmed Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50)
Objective soft tissue response defined by complete response (CR) or partial response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
Duration of response (DOR)
Proportion of participants alive and not progressed at 6 months
PSA Progression Free Survival (PFS)
Radiographic progression free survival (rPFS)
Overall survival (OS)
Overall Survival (OS) rate summarized using the Kaplan-Meier method for the treated population
Pharmacokinetics - Area under the plasma concentration time curve (AUC)
Pharmacokinetics - Maximum plasma concentration (Cmax)
Pharmacokinetics - Time to Cmax (Tmax)

Full Information

First Posted
May 29, 2020
Last Updated
July 25, 2023
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT04428788
Brief Title
Study to Evaluate the Safety and Tolerability of CC-94676 in Participants With Metastatic Castration-Resistant Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2020 (Actual)
Primary Completion Date
August 27, 2023 (Anticipated)
Study Completion Date
February 27, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Prostate Cancer, CC-94676, Castration-resistant prostate cancer, Adenocarcinoma of the prostate, Prostatic Neoplasms Castration-Resistant, Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Administration of CC-94676 and CC1083611
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CC-94676
Other Intervention Name(s)
BMS-986365
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
CC1083611
Other Intervention Name(s)
BMS-986409
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
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.
Title
Dose-limiting toxicity (DLT)
Time Frame
Up to 35 days
Title
Non-tolerated dose (NTD)
Time Frame
Up to 35 days
Title
Maximum tolerated dose (MTD)
Time Frame
Up to 35 days
Secondary Outcome Measure Information:
Title
Confirmed Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50)
Time Frame
Up to approximately 4 years
Title
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
Title
Duration of response (DOR)
Time Frame
Up to approximately 4 years
Title
Proportion of participants alive and not progressed at 6 months
Time Frame
Up to 6 months after treatment is discontinued
Title
PSA Progression Free Survival (PFS)
Time Frame
Up to approximately 4 years
Title
Radiographic progression free survival (rPFS)
Time Frame
Up to approximately 4 years
Title
Overall survival (OS)
Time Frame
Up to approximately 4 years
Title
Overall Survival (OS) rate summarized using the Kaplan-Meier method for the treated population
Time Frame
Up to approximately 4 years
Title
Pharmacokinetics - Area under the plasma concentration time curve (AUC)
Time Frame
Up to 35 days
Title
Pharmacokinetics - Maximum plasma concentration (Cmax)
Time Frame
Up to 35 days
Title
Pharmacokinetics - Time to Cmax (Tmax)
Time Frame
Up to 35 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT# and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
UAB
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnab Basu, Site 118
Phone
323-865-3000
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5826
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandhya Srinivas, Site 116
Phone
650-725-2078
Facility Name
Medstar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suthee Rapisuwon, Site 122
Facility Name
Sibley Memorial Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Carducci, Site 208
Phone
410-614-3977
Facility Name
M.D. Anderson Cancer Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Aparicio, Site 119
Phone
832-312-6124
Facility Name
Florida Cancer Specialists
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manish Patel, Site 103
Phone
941-377-9993
Facility Name
Emory University.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacqueline Brown, Site 114
Phone
607-316-5695
Facility Name
Lewis Hall Singletary Oncology Center
City
Thomasville
State/Province
Georgia
ZIP/Postal Code
31792
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josh Simmons, Site 121
Phone
229-551-8645
Facility Name
University Of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Russell Szmulewitz, Site 110
Phone
773-702-7609
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Carducci, Site 108
Phone
410-614-3977
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atish Choudhury, Site 104
Facility Name
University Of Michigan Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zachery Reichert, Site 117
Phone
815-353-5419
Facility Name
START Midwest
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nehal Lakhani, Site 102
Phone
616-954-5554
Facility Name
Mount Sinai - Icahn School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bobby Liaw, Site 112
Phone
212-604-6074
Facility Name
Mount Sinai Doctors Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Withdrawn
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karie Runcie, Site 109
Phone
212-305-8923
Facility Name
Memorial Sloan Kettering cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Rathkopf, Site 105
Phone
646-422-4379
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Armstrong, Site 106
Phone
919-668-8797
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Palyca, Site 120
Phone
610-402-9543
Facility Name
Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Withdrawn
Facility Name
Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivek Narayan, Site 113
Phone
215-360-0706
Facility Name
Ut Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Courtney, Site 107
Phone
214-648-1948
Facility Name
South Texas Accelerated Research Therapeutics (START)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Drew Rasco, Site 101
Phone
210-593-5250
Facility Name
Fred Hutchinson.Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Hawley, Site 115
Phone
206-606-2284
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamid Emamekhoo, Site 111
Phone
513-862-1400

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
http://www.fda.gov/safety/medwatch/safetyinformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
http://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

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

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