Ketoconazole Administration: How it is Affected by the Body and Broken Down and How it Acts on the Body When Used With Velcade

Millennium Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Tumors

Treatments

Drug: bortezomib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00129207

M34103-059

Details and patient eligibility

About

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 drug acts on the body) of the active ingredient in the study drug Velcade (bortezomib).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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