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

NCT00129207 | Completed Phase 1

• 1 other identifier: M34103-059
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Tumors

Keywords

pharmacokinetic; pharmacodynamics; VELCADE; Ketoconazole; CYP 3A4; Solid Tumor; Advanced Solid Tumors

Interventions

bortezomib DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

Study Sites (1)

Medical Center, UPMC Cancer Pavilion

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (1)

• 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. doi: 10.1016/j.clinthera.2009.11.012.

  PMID: 20110052 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Bortezomib

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 9, 2005
• First Posted: August 11, 2005
• Primary Completion: September 1, 2006
• Last Updated: February 11, 2008

Record last verified: 2008-02

Locations

US (1)