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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05678283
Collaborator
(none)
8
Enrollment
2
Locations
2
Arms
15.6
Anticipated Duration (Months)
4
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jan 9, 2023
Anticipated Primary Completion Date :
Apr 29, 2024
Anticipated Study Completion Date :
Apr 29, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1: CC-90010 followed by [14C]CC-90010

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

Drug: CC-90010
Specified dose on specified days
Other Names:
  • BMS-986378

    		•
    Experimental: Part 2: CC-90010

    Drug: CC-90010
    Specified dose on specified days
    Other Names:
  • BMS-986378

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Total [14C]-radioactivity in whole blood, plasma, urine, and feces (and vomit, if applicable) [Up to 26 Days]

    2. 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]

    3. Total [14C]-radioactivity whole blood to plasma ratios [Up to 26 Days]

    4. Peak plasma drug concentration (Cmax) [Up to 26 Days]

    5. Time to peak plasma drug concentration (Tmax) [Up to 26 Days]

    6. 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

    1. Biotransformation of [14C]CC-90010 as [14C]-related metabolites in plasma, urine, and feces [Up to 26 Days]

    2. Number of participants with adverse events (AEs) [Up to 26 Months]

    3. Number of participants with physical examination abnormalities [Up to 26 Months]

    4. Number of participants with vital sign abnormalities [Up to 26 Months]

    5. Number of participants with electrocardiogram (ECG) abnormalities [Up to 26 Months]

    6. Number of participants with clinical laboratory abnormalities [Up to 26 Months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts 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/exclusion criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution - 0002 Madrid M Spain 28046
    2 Local Institution - 0001 Madrid Spain 28050

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT05678283
    Other Study ID Numbers:
    • CA076-001
    • 2021-005203-13
    First Posted:
    Jan 10, 2023
    Last Update Posted:
    Jan 10, 2023
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bristol-Myers Squibb
    CC-90010
    Neoplasms
    Solid Tumors
    [14C]CC-90010
    BMS-986378
    BET Inhibitor
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Jan 10, 2023