Study of Dasatinib in Patients With Advanced Solid Tumors - Full Text View

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 I

MedlinePlus related topics:

Cancer

ChemIDplus related topics:

Dasatinib Ketoconazole

U.S. FDA Resources

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

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

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

Arms	Assigned Interventions
1: Active Comparator	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Study ID Numbers:	CA180-021
First Received:	September 9, 2005
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00162214
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Advanced Solid Tumors

Study placed in the following topic categories:

Clotrimazole

Miconazole

Dasatinib

Tioconazole

Ketoconazole

Additional relevant MeSH terms:

Anti-Infective Agents

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Antifungal Agents

Enzyme Inhibitors

Protein Kinase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 19, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00162214