Status:
TERMINATED
A Phase I Study of BMS-275183 Given on a Daily Schedule in Patients With Advanced Malignancies
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this clinical research study is to learn about the safety and tolerability of daily BMS-275183 in patients with advanced cancer.
Eligibility Criteria
Inclusion
- Non-hematologic malignancy that has progressed or no standard therapy is known
- Four weeks from last chemotherapy or two weeks from last non-cytotoxic therapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- No more than 3 prior chemotherapy regimens in advanced/metastatic setting
- Absolute neutrophil count \>=1,500/mm3 and platelets \>=100,000/mm3
- Bilirubin \<=1.5 x Upper Limit of Normal (ULN), Aspartate aminotransferase \<=2.5 x ULN
- Serum creatinine \<=1.5 x ULN
- Men and women \>=18 years
- Women of Child Bearing Potential (WOCBP) must use adequate method of contraception throughout and up to 4 weeks after the study
Exclusion
- WOCBP and men not using adequate method of birth control
- WOCBP who are pregnant or breastfeeding
- Prior radiation \>=25% of bone marrow containing skeleton
- Uncontrolled, significant, or active cardiovascular or pulmonary disease or infection or psychiatric disorder
- Neuropathy
- Active brain metastases
- Inability to swallow capsules
- History of gastrointestinal disease, surgery or malabsorption, or requiring use of a feeding tube
- Concurrent chemotherapy, hormonal therapy, immunotherapy, or radiotherapy
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00207025
Start Date
October 1 2004
Last Update
March 2 2010
Active Locations (3)
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1
Local Institution
Detroit, Michigan, United States
2
Local Institution
Pittsburgh, Pennsylvania, United States
3
Local Institution
Brussels, Belgium