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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1251-9174 | Other Identifier | WHO |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of CC-94676, CC1083611, and CC1083610 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-94676 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 thesubject discontinues study treatment. | |
| Dose-limiting toxicity (DLT) | Up to 35 days | |
| Non-tolerated dose (NTD) | Up to 35 days | |
| Maximum tolerated dose (MTD) | Up to 35 days |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 116 | Stanford | California | 94305-5826 | United States | ||
| Local Institution - 122 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39293515 | Derived | Rathkopf DE, Patel MR, Choudhury AD, Rasco D, Lakhani N, Hawley JE, Srinivas S, Aparicio A, Narayan V, Runcie KD, Emamekhoo H, Reichert ZR, Nguyen MH, Wells AL, Kandimalla R, Liu C, Suryawanshi S, Han J, Wu J, Arora VK, Pourdehnad M, Armstrong AJ. Safety and clinical activity of BMS-986365 (CC-94676), a dual androgen receptor ligand-directed degrader and antagonist, in heavily pretreated patients with metastatic castration-resistant prostate cancer. Ann Oncol. 2025 Jan;36(1):76-88. doi: 10.1016/j.annonc.2024.09.005. Epub 2024 Sep 16. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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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/
See Plan Description
See Plan Description
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| CC1083611 | Drug | Specified dose on specified days |
|
|
| CC1083610 | Drug | Specified dose on specified days |
|
|
| Up to approximately 4 years |
| Duration of response (DOR) | Up to approximately 4 years |
| Proportion of participants alive and not progressed at 6 months | Up to 6 months after treatment is discontinued |
| PSA Progression Free Survival (PFS) | Up to approximately 4 years |
| Radiographic progression free survival (rPFS) | Up to approximately 4 years |
| Overall survival (OS) | Up to approximately 4 years |
| Overall Survival (OS) rate summarized using the Kaplan-Meier method for the treated population | Up to approximately 4 years |
| Pharmacokinetics - Area under the plasma concentration time curve (AUC) | Up to 35 days |
| Pharmacokinetics - Maximum plasma concentration (Cmax) | Up to 35 days |
| Pharmacokinetics - Time to Cmax (Tmax) | Up to 35 days |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Local Institution - 103 | Sarasota | Florida | 34232 | United States |
| Local Institution - 121 | Thomasville | Georgia | 31792 | United States |
| Local Institution - 108 | Baltimore | Maryland | 21287 | United States |
| Local Institution - 104 | Boston | Massachusetts | 02215 | United States |
| Local Institution - 117 | Ann Arbor | Michigan | 48109 | United States |
| Local Institution - 102 | Grand Rapids | Michigan | 49546 | United States |
| Local Institution - 112 | New York | New York | 10029 | United States |
| Local Institution - 109 | New York | New York | 10032 | United States |
| Local Institution - 105 | New York | New York | 10065 | United States |
| Local Institution - 106 | Durham | North Carolina | 27710 | United States |
| Local Institution - 120 | Allentown | Pennsylvania | 18103 | United States |
| Local Institution - 113 | Philadelphia | Pennsylvania | 19104 | United States |
| Local Institution - 107 | Dallas | Texas | 75235 | United States |
| Local Institution - 119 | Houston | Texas | 77030 | United States |
| Local Institution - 101 | San Antonio | Texas | 78229 | United States |
| Local Institution - 115 | Seattle | Washington | 98109 | United States |
| Local Institution - 111 | Madison | Wisconsin | 53792 | United States |
| BMS Clinical Trial Patient Recruiting | View source |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D064129 | Prostatic Neoplasms, Castration-Resistant |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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