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The purpose of this study is to evaluate the mass balance, metabolism, elimination, and drug levels of [14C]-BMS-986504 (MRTX1719) in participants with advanced solid tumors with homozygous methylthioadenosine phosphorylase deletion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-BMS-986504 followed by BMS-986504 Monotherapy | Experimental | Part A: Participants will receive a single oral dose of radiolabeled [14C]-BMS-986504 on C1D1. Part B: Participants will receive non-radiolabeled BMS-986504, starting from C1D1 and until criteria for treatment discontinuation are met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986504 | Drug | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) | Up to 2 weeks | |
| Time of maximum observed drug concentration (Tmax) | Up to 2 weeks | |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) | Up to 2 weeks | |
| Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Up to 2 weeks | |
| Terminal elimination half-life (T-HALF) | Up to 2 weeks | |
| Apparent total body clearance (CLT/F) | Up to 2 weeks | |
| Apparent volume of distribution during the terminal phase (Vz/F) | Up to 2 weeks | |
| Percentage of estimated part for the calculation of AUC(INF) (%AUC(INF)) | Up to 2 weeks | |
| Blood-to-plasma total radioactivity (TRA) ratio | Up to 2 weeks | |
| Total amount of administered dose recovered in urine (UR) | Up to 2 weeks | |
| Percent of administered dose recovered in urine (%UR) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to 2 years | |
| Number of participants with serious adverse events (SAEs) | Up to 2 years | |
| Number of participants with AEs leading to discontinuation |
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Inclusion Criteria
Exclusion Criteria
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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 |
|---|---|---|---|---|---|---|
| ICON / PRA Magyarország Kft. Fázis I-es Klinikai Farmakológiai Vizsgálóhely | Recruiting | Budapest | 1076 | Hungary |
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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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| [14C]-BMS-986504 |
| Drug |
Specified dose on specified days |
|
| Up to 2 weeks |
| Renal clearance (CLR) in urine | Up to 2 weeks |
| Total radioactivity in UR | Up to 2 weeks |
| Total radioactivity in %UR | Up to 2 weeks |
| Total radioactivity in total amount of administered dose recovered in feces (FR) | Up to 2 weeks |
| Total radioactivity in percent of administered dose recovered in feces (%FR) | Up to 2 weeks |
| Total amount of radioactivity recovered (Rtotal) | Up to 2 weeks |
| Total percent of radioactivity recovered (%TOTAL) | Up to 2 weeks |
| TRA amount recovered and fraction of the radioactive dose in vomit if applicable | Up to 2 weeks |
| Up to 2 years |
| Number of participants with drug-related AEs | Up to 2 years |
| Number of participants with laboratory abnormalities | Up to 2 years |
| Number of deaths | Up to 2 years |
| START Rioja, The START Center for cancer research | Recruiting | Logroño | 26006 | Spain |
|
| Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid, | Recruiting | Madrid | 28050 | Spain |
|