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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

Effect of Ketoconazole Administration on the Pharmacokinetics and Pharmacodynamics of Bortezomib in Patients With Advanced Solid Tumors

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00129207
Enrollment
Unknown
Registered
2005-08-11
Start date
Unknown
Completion date
Unknown
Last updated
2008-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tumors

Keywords

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

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).

Interventions

DRUGbortezomib

Sponsors

Millennium Pharmaceuticals, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026