A Study of Absorption, Metabolism, and Elimination CC-90010 in Participants With Advanced Solid Tumors
- Registration Number
- NCT05678283
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to assess the absorption, metabolism, and elimination of CC-90010 and its metabolites following a single oral dose of radiolabeled CC-90010 in participants with advanced solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
- Males ≥ 18 years of age
- Has histological or cytological confirmation of advanced solid tumors including those who have progressed on standard anticancer therapy or for whom no other approved conventional therapy exists
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1
Exclusion Criteria
- Persistent diarrhea National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade ≥ 2
- History of concurrent second cancers requiring active and ongoing systemic treatment
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Part 1: CC-90010 followed by [14C]CC-90010 [14C]CC-90010 - Part 1: CC-90010 followed by [14C]CC-90010 CC-90010 - Part 2: CC-90010 CC-90010 -
- Primary Outcome Measures
Name Time Method Total [14C]-radioactivity in whole blood, plasma, urine, and feces (and vomit, if applicable) Up to 26 Days Cumulative elimination of total [14C]-radioactivity (as a fraction of the radioactive dose) in urine and feces (and vomit, if applicable) Up to 14 Days Total [14C]-radioactivity whole blood to plasma ratios Up to 26 Days Peak plasma drug concentration (Cmax) Up to 26 Days Time to peak plasma drug concentration (Tmax) Up to 26 Days Area under the concentration-time curve from time zero to time the time of the last measurable concentration (AUC[0-T]) Up to 26 Days
- Secondary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) Up to 26 Months Biotransformation of [14C]CC-90010 as [14C]-related metabolites in plasma, urine, and feces Up to 26 Days Number of participants with physical examination abnormalities Up to 26 Months Number of participants with vital sign abnormalities Up to 26 Months Number of participants with electrocardiogram (ECG) abnormalities Up to 26 Months Number of participants with clinical laboratory abnormalities Up to 26 Months
Trial Locations
- Locations (1)
Local Institution - 0002
🇪🇸Madrid, M, Spain