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

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05678283
• Other study ID #: CA076-001
• Secondary ID: 2021-005203-13
• Status: Withdrawn
• Phase: Phase 1
• Start date: January 9, 2023
• Est. completion date: April 29, 2024

Study information

• Verified date: April 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 29, 2024
• Est. primary completion date: April 29, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• [14C]CC-90010
Specified dose on specified days
• CC-90010
Specified dose on specified days

Locations

Country	Name	City	State
Spain	Local Institution - 0002	Madrid	M

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total [14C]-radioactivity in whole blood, plasma, urine, and feces (and vomit, if applicable)		Up to 26 Days
Primary	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
Primary	Total [14C]-radioactivity whole blood to plasma ratios		Up to 26 Days
Primary	Peak plasma drug concentration (Cmax)		Up to 26 Days
Primary	Time to peak plasma drug concentration (Tmax)		Up to 26 Days
Primary	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	Biotransformation of [14C]CC-90010 as [14C]-related metabolites in plasma, urine, and feces		Up to 26 Days
Secondary	Number of participants with adverse events (AEs)		Up to 26 Months
Secondary	Number of participants with physical examination abnormalities		Up to 26 Months
Secondary	Number of participants with vital sign abnormalities		Up to 26 Months
Secondary	Number of participants with electrocardiogram (ECG) abnormalities		Up to 26 Months
Secondary	Number of participants with clinical laboratory abnormalities		Up to 26 Months

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form