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

NCT05678283 | Withdrawn Phase 1 FDA Drug

• 2 other identifiers: CA076-0012021-005203-13
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Keywords

CC-90010; Neoplasms; Solid Tumors; [14C]CC-90010; BMS-986378; BET Inhibitor

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• 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

Study Arms (2)

Part 1: CC-90010 followed by [14C]CC-90010

EXPERIMENTAL

Drug: [14C]CC-90010; Drug: CC-90010

Part 2: CC-90010

EXPERIMENTAL

Drug: CC-90010

Interventions

[14C]CC-90010 DRUG

Specified dose on specified days

Part 1: CC-90010 followed by [14C]CC-90010

CC-90010 DRUG

Specified dose on specified days

Also known as: BMS-986378

Part 1: CC-90010 followed by [14C]CC-90010; Part 2: CC-90010

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0002

Madrid, M, 28046, Spain

Location

Related Links

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

MeSH Terms

Conditions

Neoplasms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 10, 2023
• Study Start: January 9, 2023
• Primary Completion: April 29, 2024
• Study Completion: April 29, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)