A Phase I Study of BMS-275183 Given on a Daily Schedule in Patients With Advanced Malignancies
Inclusion Criteria:
- 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 Criteria:
- 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