Study of Dasatinib in Patients With Advanced Solid Tumors
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
1 other identifier
interventional
60
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2005
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 13, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedApril 14, 2011
April 1, 2011
1.6 years
September 9, 2005
April 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
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
Study Arms (1)
1
ACTIVE COMPARATORInterventions
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- Serious cardiovascular disease
- Bleeding disorders
- Gastrointestinal (GI) tract disease
- Platelet inhibitors
- H2 blockers, proton pump inhibitors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Lee S. Rosen M.D.
Santa Monica, California, 90404, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Md Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 13, 2005
Study Start
August 1, 2005
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
April 14, 2011
Record last verified: 2011-04