Status:
TERMINATED
A Study of BMS-863233 in Patients With Advanced and/or Metastatic Solid Tumors
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Exelixis
Conditions:
Advanced Solid Cancers
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- Phase 1
- 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
- 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
Key Trial Info
Start Date :
May 31 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 4 2010
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00886782
Start Date
May 31 2009
End Date
August 4 2010
Last Update
April 28 2023
Active Locations (6)
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1
Dana-Farber Cancer Institute-Vendor
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
4
Local Institution - 003
Toronto, Ontario, Canada, M5G 2M9