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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 1

Conditions: Tumors

Treatments: Drug: BMS-275183

Study type: Interventional

Funder types: Industry

Identifiers

NCT00207025

CA165-012

Details and patient eligibility

About

The purpose of this clinical research study is to learn about the safety and tolerability of daily BMS-275183 in patients with advanced cancer.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)