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Study of Dasatinib in Patients With Advanced Solid Tumors

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00162214
First Posted: September 13, 2005
Last Update Posted: April 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
  Purpose
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.

Condition Intervention Phase
Tumors Drug: Dasatinib + Ketoconazole Phase 1

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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome 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 Outcome 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

Estimated Enrollment: 60
Study Start Date: August 2005
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 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.
Other Name: Sprycel

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162214


Locations
United States, California
Lee S. Rosen M.D.
Santa Monica, California, United States, 90404
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Md Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00162214     History of Changes
Other Study ID Numbers: CA180-021
First Submitted: September 9, 2005
First Posted: September 13, 2005
Last Update Posted: April 14, 2011
Last Verified: April 2011

Keywords provided by Bristol-Myers Squibb:
Advanced Solid Tumors

Additional relevant MeSH terms:
Dasatinib
Ketoconazole
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors