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

Phase 1
18 Years
Not Enrolling

Thank you

Trial Information

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and Tolerability


United States: Food and Drug Administration

Study ID:




Start Date:

October 2004

Completion Date:

Related Keywords:

  • Tumors
  • Patients with advanced solid tumors



Local InstitutionDuncansville, Pennsylvania  
Local InstitutionDetroit, Michigan