Tumors
Conditions
Keywords
Patients with advanced solid tumors
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.
Interventions
DRUGBMS-275183
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability | — |
Secondary
| Measure | Time frame |
|---|---|
| PK, preliminary evidence of antitumor activity | — |
Countries
Belgium, United States
Outcome results
None listed