A Study of Absorption, Metabolism, and Elimination CC-90010 in Participants With Advanced Solid Tumors

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, 2-Part, Open-label Study to Determine the Absorption, Metabolism, and Elimination of [14C]CC-90010 in Participants With Advanced Solid Tumors

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: [14C]CC-90010
* Drug: CC-90010


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: CC-90010 followed by [14C]CC-90010<br> | Drug: [14C]CC-90010<br>* Specified dose on specified days<br>Drug: CC-90010<br>* Specified dose on specified days<br>* Other names: BMS-986378;|
| Experimental: Part 2: CC-90010<br> | Drug: CC-90010<br>* Specified dose on specified days<br>* Other names: BMS-986378;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CC-90010, Neoplasms, Solid Tumors, [14C]CC-90010, BMS-986378, BET Inhibitor