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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Tumors

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Authority:

United States: Food and Drug Administration

Study ID:

CA180-021

NCT ID:

NCT00162214

Start Date:

August 2005

Completion Date:

March 2007

Related Keywords:

  • Tumors
  • Advanced Solid Tumors

Name

Location
MD Anderson Cancer Center Houston, Texas  77030-4096
H. Lee Moffitt Cancer Center Tampa, Florida  33612
Sarah Cannon Research Institute Nashville, Tennessee  37203
Lee S. Rosen M.D. Santa Monica, California  90404