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

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

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: 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:

MedlinePlus related topics: Cancer

Drug Information available for: Ketoconazole Fungarest Dasatinib

U.S. FDA Resources

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

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

Additional 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

No publications provided

ClinicalTrials.gov Identifier:	NCT00162214 History of Changes
Other Study ID Numbers:	CA180-021
Study First Received:	September 9, 2005
Last Updated:	April 13, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Advanced Solid Tumors

Additional relevant MeSH terms:

Ketoconazole
Dasatinib
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012