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:
Information provided by:
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00129207
First received: August 9, 2005
Last updated: February 7, 2008
Last verified: February 2008
  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
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:


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
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, see Learn About Clinical Studies.

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):
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
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 19, 2014