Study of Dasatinib in Patients With Advanced Solid Tumors

Tumors Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00162214
• Other study ID #: CA180-021
• Status: Terminated
• Phase: Phase 1
• First received: September 9, 2005
• Last updated: April 13, 2011
• Start date: August 2005
• Est. completion date: March 2007

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tumors

Intervention

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.

Locations

Country	Name	City	State
United States	Md Anderson Cancer Center	Houston	Texas
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Lee S. Rosen M.D.	Santa Monica	California
United States	H. Lee Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Segment 2: Assess the pharmacodynamic activity of dasatinib
Secondary	Segment 1: Evaluate the safety and tolerability of dasatinib alone and when co-administered with ketoconazole
Secondary	Segment 2: Explore the association between tumor response and the pre-clinically identified markers and other mRNA gene expression level

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm