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CompletedNCT00129207Updated Feb 11, 2008

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

A Phase 1 interventional study of bortezomib in Tumors, sponsored by Millennium Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-02-11.

Sponsored by Millennium Pharmaceuticals, Inc. (part of Takeda) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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).

02

Conditions studied

  • Tumors

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Keywords

  • pharmacokinetic
  • pharmacodynamics
  • VELCADE
  • Ketoconazole
  • CYP 3A4
  • Solid Tumor
  • Advanced Solid Tumors
03

In context

Neoplasms

9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

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Lead sponsor

Millennium Pharmaceuticals, Inc. is the lead sponsor of 178 studies on the registry; none are open to participants now.

Of its 74 completed or terminated interventional studies of FDA-regulated products, 73 (99%) have results posted.

First submitted before Millennium Pharmaceuticals, Inc. became part of Takeda.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)

Interventions

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Study locations

1 site
  • Medical Center, UPMC Cancer Pavilion
    Pittsburgh, Pennsylvania 15232, United States
07

References and documents

Publications

  • 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. PubMed 20110052 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00129207
First posted
Aug 11, 2005
Primary completion
Sep 2006
Last update
Feb 11, 2008
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Bortezomib

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