Study of Dasatinib in Patients With Advanced Solid Tumors
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tumors
Intervention: dasatinib (Drug); ketoconazole (Drug)
Phase: Phase 1
Status: Terminated
Sponsored by: Bristol-Myers Squibb
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.
Clinical Details
Official title: Phase I Study to Evaluate the Effect of Ketoconazole on the Pharmacokinetics of Dasatinib and the Effect of Dasatinib on Pharmacodynamic Markers in Patients With Advanced Solid Tumors
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: 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 tumorsSegment 2: Assess the pharmacodynamic activity of dasatinib
Secondary outcome: Segment 1: Evaluate the safety and tolerability of dasatinib alone and when co-administered with ketoconazoleSegment 2: Explore the association between tumor response and the pre-clinically identified markers and other mRNA gene expression level
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Lee S. Rosen M.D., Santa Monica, California 90404, United States
H. Lee Moffitt Cancer Center, Tampa, Florida 33612, United States
Sarah Cannon Research Institute, Nashville, Tennessee 37203, United States
Md Anderson Cancer Center, Houston, Texas 77030, United States
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Starting date: August 2005
Last updated: September 19, 2007
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