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

Stopped early · Phase 1

Conditions studied: Tumors

In brief

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

Key facts

Study ID

NCT00207025

Run by

Bristol-Myers Squibb

People needed

60

Starts

2004-10-01

Last updated by the study team

2010-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution — Detroit, Michigan, United States
• Local Institution — Pittsburgh, Pennsylvania, United States
• Local Institution — Brussels, Belgium

Full record on ClinicalTrials.gov

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