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

Tumors Clinical Trial

Official title:

Effect of Ketoconazole Administration on the Pharmacokinetics and Pharmacodynamics of Bortezomib in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00129207
• Other study ID #: M34103-059
• Status: Completed
• Phase: Phase 1
• First received: August 9, 2005
• Last updated: February 7, 2008

Study information

• Verified date: February 2008
• Source: Millennium Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Tumors

Intervention

Drug:
• bortezomib

Locations

Country	Name	City	State
United States	Medical Center, UPMC Cancer Pavilion	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States,