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

NCT ID: NCT00129207

Last Updated: 2008-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL

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

Conditions

Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

bortezomib

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Locations

Medical Center, UPMC Cancer Pavilion

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Venkatakrishnan K, Rader M, Ramanathan RK, Ramalingam S, Chen E, Riordan W, Trepicchio W, Cooper M, Karol M, von Moltke L, Neuwirth R, Egorin M, Chatta G. Effect of the CYP3A inhibitor ketoconazole on the pharmacokinetics and pharmacodynamics of bortezomib in patients with advanced solid tumors: a prospective, multicenter, open-label, randomized, two-way crossover drug-drug interaction study. Clin Ther. 2009;31 Pt 2:2444-58. doi: 10.1016/j.clinthera.2009.11.012.

Reference Type: DERIVED

PMID: 20110052 (View on PubMed)

Other Identifiers

M34103-059

Identifier Type: -

Identifier Source: org_study_id