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

Phase 1

Terminated

• Conditions: Tumors

• Registration Number: NCT00207025
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-21
• Primary Completion: 2007-02
• Status Verified: 2008-07
• Disposition First Submitted: 2010-02-27
• Disposition First Submitted QC: 2010-02-27
• Last Update Submitted: 2010-02-27
• Disposition First Posted: 2010-03-02
• Last Update Posted: 2010-03-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability

Secondary Outcome Measures

Name	Time	Method
PK, preliminary evidence of antitumor activity

Trial Locations

Locations (1)

Local Institution; 🇧🇪 Brussels, Belgium