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A Pilot Trial of Itraconazole Pharmacokinetics in Patients With Metastatic Breast Cancer

NCT00798135 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2023-12-21

Study results available
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Summary

Cancer cells need to be able to make new blood vessels in order to keep growing. This is called angiogenesis. In a laboratory setting, the drug itraconazole was shown to help stop the growth of new blood vessels (anti-angiogenesis). It is hoped that itraconazole will prevent new blood vessels from forming in humans too.

The purpose of this study is to look at how the body processes and breaks down itraconazole (called pharmacokinetics). This study will also measure markers in your blood to see if itraconazole stops new blood vessels from forming. The safety of itraconazole will also be tested to see what effects (good and bad) it has on you and your breast cancer.

Conditions

  • Breast Neoplasms
  • Neoplasm Metastasis

Interventions

DRUG

itraconazole

oral itraconazole 200mg a day until disease progression or unacceptable toxicities.

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Kathy Miller, MD · Indiana University Melvin and Bren Simon Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2012-02-29
Completion
2012-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00798135 on ClinicalTrials.gov