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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513987-24 | Other Identifier | EU CTR | |
| U1111-1307-2450 | Other Identifier | WHO |
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The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of BMS-986460 in men with Metastatic Castration-resistant Prostate Cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of BMS-986460 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986460 | Drug | Specified dose on specified days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to 112 weeks | |
| Number of participants with serious adverse events (SAEs) | Up to 112 weeks | |
| Number of participants with AEs meeting protocol defined dose limiting toxicity (DLT) criteria | Up to 28 days | |
| Number of participants with AEs leading to study intervention discontinuation | Up to 104 weeks | |
| Number of deaths | Up to 108 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) | Up to 13 weeks | |
| Time of maximum concentration (Tmax) | Up to 13 weeks | |
| Area under the plasma concentration-time curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Center | Recruiting | Palo Alto | California | 94304 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
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| Up to 13 weeks |
| Number of participants with a confirmed prostate specific antigen decline of ≥ 30% from baseline response rate | Up to 108 weeks |
| Number of participants with soft tissue response | Up to 108 weeks |
| Duration of response (DOR) | Up to 108 weeks |
| Florida Cancer Specialists Sarasota Drug Development Unit | Recruiting | Sarasota | Florida | 34232 | United States |
|
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
|
| Duke Cancer Institute | Recruiting | Durham | North Carolina | 27710 | United States |
|
| Local Institution - 0006 | Withdrawn | San Antonio | Texas | 78229 | United States |
| NEXT Oncology | Recruiting | San Antonio | Texas | 78229 | United States |
|
| Fred Hutchinson Cancer Center | Recruiting | Seattle | Washington | 98109 | United States |
|
| 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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