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The purpose of this study is to evaluate the safety, tolerability and drug levels of Navlimetostat (BMS-986504) in participants with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986504 Arm | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986504 | Drug | Specified dose on specified days |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of BMS-986504 | Up to approximately Day 64 | |
| Time to Reach Maximum Plasma Concentration (Tmax) of BMS-986504 | Up to approximately Day 64 | |
| Area Under Curve (AUC) of BMS-986504 | Up to approximately Day 64 | |
| Mean Elimination Half-life (T-HALF) of BMS-986504 | Up to approximately Day 64 | |
| Apparent Total Body Clearance (CLT/F) of BMS-986504 | Up to approximately Day 64 | |
| Apparent Volume of Distribution During the Terminal Phase (Vz/F) of BMS-986504 | Up to approximately Day 64 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-limiting Toxicities (DLTs) | Up to approximately Day 25 | |
| Number of Participants With Treatment-related Adverse Events (AE) | Up to approximately 28 days after last dose of BMS-986504 |
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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 |
|---|---|---|---|---|---|---|
| Beijing Cancer hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | 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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| Number of Participants With all-cause AEs | Up to approximately 28 days after last dose of BMS-986504 |
| Number of Participants With Treatment-related Serious AEs (SAEs) | Up to approximately 28 days after last dose of BMS-986504 |
| Number of Participants With all-cause SAEs | Up to approximately 28 days after last dose of BMS-986504 |
| Number of Participants With AEs Leading to Dose Interruption | Up to approximately 28 days after last dose of BMS-986504 |
| Number of Participants With AEs Leading to Dose Reduction | Up to approximately 28 days after last dose of BMS-986504 |
| Number of Participants With AEs Leading to Treatment Discontinuation | Up to approximately 28 days after last dose of BMS-986504 |
| Number of Participants With AEs Leading to Death | Up to approximately 28 days after last dose of BMS-986504 |
| Number of Participants With Laboratory Abnormalities | Up to approximately 28 days after last dose of BMS-986504 |
| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | 350014 | China |
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| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| Peking University Shenzhen Hospital | Recruiting | Shenzhen | Guangdong | 518036 | China |
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| Harbin Medical University Cancer Hospital | Recruiting | Harbin | Heilongjiang | 150081 | China |
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| The First Affiliated Hospital of Xinxiang Medical University | Recruiting | Xinxiang | Henan | 453100 | China |
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| Shandong Cancer Hospital | Recruiting | Jinan | Shandong | 250117 | China |
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| Tianjin Medical University Cancer Institute & Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| Kanagawa cancer center | Recruiting | Yokohama | Kanagawa | 2418515 | Japan |
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| Shizuoka Cancer Center | Recruiting | Sunto-gun | Shizuoka | 411-8777 | 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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