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

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 1

Conditions: Advanced Solid Tumors

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05678283

2021-005203-13 (EudraCT Number)

CA076-001

Details and patient eligibility

About

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.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

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

Experimental group

Treatment:

Drug: CC-90010

Drug: [14C]CC-90010

Part 2: CC-90010

Experimental group

Treatment:

Drug: CC-90010