Study of Dasatinib in Patients With Advanced Solid Tumors
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...
Brief Summary
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”
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.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: March 2007
Intervention(s) in this Clinical Trial
- Drug: Dasatinib + Ketoconazole
- Tablets, Oral, Segment 1: escalating single dose of dasatinib starting at 140 mg q24 hours on Day 1-8; single dose of ketoconazole 200 mg q12 hours on Days 3-8; Segment 2: single daily oral doses of dasatinib, once daily, until disease progression or unacceptable toxicity.
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
Outcome Measures for this Clinical Trial
Primary Measures
- 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 Measures
- 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
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Bristol-Myers Squibb Industry
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00162214
Study ID Number: CA180-021
ClinicalTrials.gov Identifier: NCT00162214
Health Authority: United States: Food and Drug Administration
BMS Clinical Trials Disclosure
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00162214
