Study of Dasatinib in Patients With Advanced Solid Tumors
- Registration Number
- NCT00162214
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of Segment 1 of the study is to determine the effect of ketoconazole on dasatinib. The purpose of Segment 2 is to learn how dasatinib affects tumor growth in patients with advanced solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- ECOG status 0-2
- Advanced or metastatic disease, unresponsive to standard treatment (or no standard treatment exists)
- Biopsy pretreatment
- Adequate bone marrow, liver and kidney function
Exclusion Criteria
- Serious cardiovascular disease
- Bleeding disorders
- Gastrointestinal (GI) tract disease
- Platelet inhibitors
- H2 blockers, proton pump inhibitors
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Dasatinib + Ketoconazole -
- Primary Outcome Measures
Name Time Method Segment 1: Determine whether the steady state pharmacokinetics of 20 mg of dasatinib are affected by co-administration with ketoconazole in patients with advanced solid tumors Segment 2: Assess the pharmacodynamic activity of dasatinib
- Secondary Outcome Measures
Name Time Method Segment 1: Evaluate the safety and tolerability of dasatinib alone and when co-administered with ketoconazole Segment 2: Explore the association between tumor response and the pre-clinically identified markers and other mRNA gene expression level
Trial Locations
- Locations (4)
Lee S. Rosen M.D.
🇺🇸Santa Monica, California, United States
H. Lee Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Md Anderson Cancer Center
🇺🇸Houston, Texas, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States