Trial Information
A Phase 1/2 Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-863233 in Subjects With Advanced and/or Metastatic Solid Tumors
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine maximum tolerated dose and anti-tumor activity of BMS-863233 when administered to subjects with advanced and/or Metastatic solid tumors
Outcome Time Frame:
Every 28 days until the MTD is reached
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA198-002
NCT ID:
NCT00886782
Start Date:
May 2009
Completion Date:
August 2010
Related Keywords:
- Advanced Solid Cancers
- Metastatic Cancer
- Advanced and/or Metastatic solid cancers
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
Name | Location |
Dana-Farber Cancer Institute |
Boston, Massachusetts 02115 |
Karmanos Cancer Institute |
Detroit, Michigan 48201 |