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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-005203-13 | EudraCT Number |
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Business Objectives have changed.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: CC-90010 followed by [14C]CC-90010 | Experimental |
| |
| Part 2: CC-90010 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]CC-90010 | Drug | Specified dose on specified days |
| |
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0002 | Madrid | M | 28046 | Spain |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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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 Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| CC-90010 |
| Drug |
Specified dose on specified 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 |
| BMS Clinical Trial Patient Recruiting | View source |