A Study of BMS-863233 in Patients With Advanced and/or Metastatic Solid Tumors

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Metastatic Cancer; Advanced Solid Cancers

Treatments: Drug: Cdc7-inhibitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT00886782

EUDRACT Number: 2009-010572-20

CA198-002

Details and patient eligibility

About

The purpose of this study is to determine safety, tolerability and maximum tolerated dose of BMS-863233 in subjects advanced and/or Metastatic solid tumors.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Phase 1 Inclusion Criteria:

• Subjects with advanced and/or metastatic solid tumors who are either refractory to or have relapsed from standard therapies, or for whom a standard therapy does not exist.
• ECOG performance status ≤ 2
• Accessible for treatment, PK sample collection and required study follow-up
• Total Bilirubin ≤ 1.5 x ULN and ALT, AST ≤ 2.5 x ULN

Exclusion Criteria:

• Women who are pregnant or breastfeeding
• Subjects with known or suspected brain metastasis, primary brain tumors, or brain as the only site of disease
• Exposure to any investigational agent within 4 weeks of study drug administration
• Subjects a history of gastrointestinal disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Cdc7-inhibitor

Experimental group

Treatment:

Drug: Cdc7-inhibitor