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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05678283
Recruitment Status : Not yet recruiting
First Posted : January 10, 2023
Last Update Posted : January 10, 2023
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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
Advanced Solid Tumors Drug: [14C]CC-90010 Drug: CC-90010 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : January 9, 2023
Estimated Primary Completion Date : April 29, 2024
Estimated Study Completion Date : April 29, 2024
Arms and Interventions
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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 Name: BMS-986378
Experimental: Part 2: CC-90010 Drug: CC-90010
Specified dose on specified days
Other Name: BMS-986378


Outcome Measures
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Primary Outcome Measures :
  1. Total [14C]-radioactivity in whole blood, plasma, urine, and feces (and vomit, if applicable) [ Time Frame: 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) [ Time Frame: Up to 14 Days ]
  3. Total [14C]-radioactivity whole blood to plasma ratios [ Time Frame: Up to 26 Days ]
  4. Peak plasma drug concentration (Cmax) [ Time Frame: Up to 26 Days ]
  5. Time to peak plasma drug concentration (Tmax) [ Time Frame: 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]) [ Time Frame: Up to 26 Days ]

Secondary Outcome Measures :
  1. Biotransformation of [14C]CC-90010 as [14C]-related metabolites in plasma, urine, and feces [ Time Frame: Up to 26 Days ]
  2. Number of participants with adverse events (AEs) [ Time Frame: Up to 26 Months ]
  3. Number of participants with physical examination abnormalities [ Time Frame: Up to 26 Months ]
  4. Number of participants with vital sign abnormalities [ Time Frame: Up to 26 Months ]
  5. Number of participants with electrocardiogram (ECG) abnormalities [ Time Frame: Up to 26 Months ]
  6. Number of participants with clinical laboratory abnormalities [ Time Frame: Up to 26 Months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05678283


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.

Locations
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Spain
Local Institution - 0002
Madrid, M, Spain, 28046
Contact: Site 0002         
Local Institution - 0001
Madrid, Spain, 28050
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05678283    
Other Study ID Numbers: CA076-001
2021-005203-13 ( EudraCT Number )
First Posted: January 10, 2023    Key Record Dates
Last Update Posted: January 10, 2023
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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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:
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Neoplasms