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

This study has been completed.

First Received on August 9, 2005. Last Updated on February 7, 2008 History of Changes

Sponsor:	Millennium Pharmaceuticals, Inc.
Information provided by:	Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00129207

Purpose

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).

Condition	Intervention	Phase
Tumors	Drug: bortezomib	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effect of Ketoconazole Administration on the Pharmacokinetics and Pharmacodynamics of Bortezomib in Patients With Advanced Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Ketoconazole Fungarest Bortezomib

U.S. FDA Resources

Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Completion Date:

September 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129207

Locations

United States, Pennsylvania
Medical Center, UPMC Cancer Pavilion
Pittsburgh, Pennsylvania, United States, 15232

Sponsors and Collaborators

Millennium Pharmaceuticals, Inc.

More Information

No publications provided by Millennium Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00129207 History of Changes
Other Study ID Numbers:	M34103-059
Study First Received:	August 9, 2005
Last Updated:	February 7, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Millennium Pharmaceuticals, Inc.:

pharmacokinetic
pharmacodynamics
VELCADE
Ketoconazole

CYP 3A4
Solid Tumor
Advanced Solid Tumors

Additional relevant MeSH terms:

Ketoconazole
Bortezomib
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Antineoplastic Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012