Advanced Solid Tumors With Homozygous MTAP Deletion
Conditions
Keywords
Protein arginine methyltransferase (PRMT5), Methylthioadenosine-cooperative PRMT5 inhibitor, Homozygous methylthioadenosine phosphorylase (MTAP) deletion, Mass balance study, Metabolism, Elimination, Drug absorption, Distribution, Excretion, Radiolabeled, Absorption, distribution, metabolism, and excretion (ADME)
Brief summary
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.
Interventions
DRUGBMS-986504
Specified dose on specified days
DRUG[14C]-BMS-986504
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must have an advanced, unresectable, or metastatic solid tumor malignancy with a deletion of the methylthioadenosine phosphorylase (MTAP) gene. * Participants must have received, be refractory to, be ineligible for, or be intolerant of available standard care for their cancer.
Exclusion criteria
* Participants must not have a history of any surgical or medical conditions possibly affecting how the study drug is distributed, broken down (metabolized) and removed (excreted or eliminated) from the body. * Participants must not have participated in a clinical study involving a radiolabeled study drug within 12 months prior to admission to the research center. * Participants must not have a current or recent (within 3 months of study drug administration) gastrointestinal disease. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TRA amount recovered and fraction of the radioactive dose in vomit if applicable | 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 |
| 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) | Up to 2 weeks |
| Renal clearance (CLR) in urine | Up to 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with serious adverse events (SAEs) | Up to 2 years |
| Number of participants with AEs leading to discontinuation | 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 |
| Number of participants with adverse events (AEs) | Up to 2 years |
Countries
Hungary
Contacts
Primary ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Backup ContactFirst line of the email MUST contain the NCT# and Site#
Outcome results
None listed