Status:
COMPLETED
Ketoconazole Administration: How it is Affected by the Body and Broken Down and How it Acts on the Body When Used With Velcade
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate how ketoconazole (Nizoral) affects the pharmacokinetics (how the study drug is affected by the body and broken down) and pharmacodynamics (how the study dru...
Eligibility Criteria
Inclusion
- Male and female patients 18 years of age or older, with a diagnosis of advanced solid tumor for which no curative or other treatment of higher priority is available
- Karnofsky Performance Status (KPS) equal to or greater than 70%
- Normal liver function tests (aspartate transaminase \[AST\] or alanine transaminase \[ALT\] equal to or less than 2 x upper limit of normal \[ULN\])
- Total bilirubin equal to or less than 1.5 x ULN
- Calculated creatinine clearance equal to or greater than 50 mL/min
- Normal serum calcium
Exclusion
- Patients with significant cardiac disease
- Equal to or greater than Grade 2 neuropathy
- Active hepatitis
- HIV infection
- Secondary malignancy
- Transfusion-dependent or received extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 4 weeks of enrollment
- Patients taking concomitant medications having inhibitory or inducing activity for CYP 3A4
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00129207
Last Update
February 11 2008
Active Locations (1)
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1
Medical Center, UPMC Cancer Pavilion
Pittsburgh, Pennsylvania, United States, 15232