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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00129207
First Posted: August 11, 2005
Last Update Posted: February 11, 2008
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.
Information provided by:
Millennium Pharmaceuticals, Inc.
  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 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00129207


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00129207     History of Changes
Other Study ID Numbers: M34103-059
First Submitted: August 9, 2005
First Posted: August 11, 2005
Last Update Posted: February 11, 2008
Last Verified: February 2008

Keywords provided by Millennium Pharmaceuticals, Inc.:
pharmacokinetic
pharmacodynamics
VELCADE
Ketoconazole
CYP 3A4
Solid Tumor
Advanced Solid Tumors

Additional relevant MeSH terms:
Bortezomib
Ketoconazole
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