Advanced Solid Tumors
Conditions
Keywords
CC-90010, Neoplasms, Solid Tumors, [14C]CC-90010, BMS-986378, BET Inhibitor
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.
Interventions
DRUG[14C]CC-90010
Specified dose on specified days
DRUGCC-90010
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
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Biotransformation of [14C]CC-90010 as [14C]-related metabolites in plasma, urine, and feces | Up to 26 Days |
| Number of participants with adverse events (AEs) | Up to 26 Months |
| 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 |
Countries
Spain
Outcome results
None listed