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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524334-26-00 | Other Identifier | EU CTR | |
| U1111-1330-3304 | Other Identifier | WHO |
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The purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4/6 inhibitor pre-treated advanced breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1A Monotherapy Dose Escalation | Experimental |
| |
| Part 1B Combination Dose Escalation | Experimental |
| |
| Part 1C Monotherapy Pharmacodynamic (PD) Sub-study | Experimental |
| |
| Part 2A Monotherapy Dose Expansion | Experimental |
| |
| Part 2B Combination Dose Expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986500 | Drug | Specified dose of specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | Up to Day 28 From Last Dose | |
| Number of Participants With Adverse Events (AEs) | Up to Day 28 From Last Dose | |
| Number of Participants With Serious Adverse Events (SAEs) | Up to Day 28 From Last Dose | |
| Number of Participants With AEs Leading to Discontinuation | Up to Day 28 From Last Dose | |
| Number of Participants With TEAEs Leading to Death | Up to Day 28 From Last Dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of BMS-986500 | Up to Approximately 2 Years | |
| Time of Maximum Observed Serum Concentration (Tmax) of BMS-986500 | Up to Approximately 2 Years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.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 |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35294-3300 | 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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| Palbociclib | Drug | Specified dose on specified days |
|
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| Fulvestrant | Drug | Specified dose on specified days |
|
|
| Area Under the Concentration-time Curve Within a Dosing Interval (AUC(TAU)) of BMS-986500 |
| Up to Approximately 2 Years |
| Providence St. Jude Medical Center | Recruiting | Fullerton | California | 92835 | United States |
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| Marin Cancer Care | Recruiting | Greenbrae | California | 94904 | United States |
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| Moores Cancer Center | Recruiting | La Jolla | California | 92093 | United States |
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| Hoag Memorial Hospital Presbyterian | Recruiting | Newport Beach | California | 92663 | United States |
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| Local Institution - 0008 | Not yet recruiting | Aurora | Colorado | 80045 | United States |
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| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
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| Dartmouth-Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | 03756 | United States |
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| Roswell Park Cancer Institute | Recruiting | Buffalo | New York | 14263 | United States |
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| Northwell Health-Cancer Institute | Recruiting | New Hyde Park | New York | 11042 | United States |
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| Local Institution - 0011 | Not yet recruiting | New York | New York | 10016 | United States |
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| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
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| START Dallas Fort Worth | Recruiting | Fort Worth | Texas | 76104 | United States |
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| NEXT Oncology | Recruiting | San Antonio | Texas | 78229 | United States |
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| Odense Universitetshospital | Recruiting | Odense | Region Syddanmark | 5000 | Denmark |
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| Copenhagen University Hospital | Recruiting | Copenhagen | 2100 | Denmark |
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| National Cancer Center Hospital East | Recruiting | Kashiwa | Chiba | 277-8577 | Japan |
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| Kansai Medical University Hospital | Recruiting | Hirakata | Osaka | 573-1191 | Japan |
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| National Cancer Center Hospital | Recruiting | Chuo-ku | Tokyo | 104-0045 | Japan |
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| The Cancer Institute Hospital of JFCR | Recruiting | Koto-ku | Tokyo | 135-8550 | Japan |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C500026 | palbociclib |
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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