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: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics/Dynamics Study

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

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

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

Lead Sponsor: Bristol-Myers Squibb

Information obtained from ClinicalTrials.gov on July 02, 2009

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

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