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

NCT ID: NCT05678283

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-09

Study Completion Date

2024-04-29

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Group Type EXPERIMENTAL

[14C]CC-90010

Intervention Type DRUG

Specified dose on specified days

CC-90010

Intervention Type DRUG

Specified dose on specified days

Part 2: CC-90010

Group Type EXPERIMENTAL

CC-90010

Intervention Type DRUG

Specified dose on specified days

Interventions

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[14C]CC-90010

Specified dose on specified days

Intervention Type DRUG

CC-90010

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-986378

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0002

Madrid, M, Spain

Site Status

Countries

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Spain

Related Links

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Other Identifiers

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2021-005203-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA076-001

Identifier Type: -

Identifier Source: org_study_id

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