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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00129207
Recruitment Status : Completed
First Posted : August 11, 2005
Last Update Posted : February 11, 2008
Information provided by:
Millennium Pharmaceuticals, Inc.

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).

Condition or disease Intervention/treatment Phase
Tumors Drug: bortezomib Phase 1

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Ketoconazole Administration on the Pharmacokinetics and Pharmacodynamics of Bortezomib in Patients With Advanced Solid Tumors
Primary Completion Date : September 2006

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00129207

United States, Pennsylvania
Medical Center, UPMC Cancer Pavilion
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00129207     History of Changes
Other Study ID Numbers: M34103-059
First Posted: August 11, 2005    Key Record Dates
Last Update Posted: February 11, 2008
Last Verified: February 2008

Keywords provided by Millennium Pharmaceuticals, Inc.:
Solid Tumor
Advanced Solid Tumors

Additional relevant MeSH terms:
Antineoplastic Agents
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors