Study of Dasatinib in Patients With Advanced Solid Tumors

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2007

Interventions

  • 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

  • Active Comparator: 1

Clinical Trial Outcome Measures

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

Participating 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: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bristol-Myers Squibb

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