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

• Status: Terminated
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Exelixis

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