A Pilot Trial of Itraconazole Pharmacokinetics in Patients With Metastatic Breast Cancer
|ClinicalTrials.gov Identifier: NCT00798135|
Recruitment Status : Completed
First Posted : November 25, 2008
Results First Posted : September 10, 2014
Last Update Posted : September 11, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms Neoplasm Metastasis||Drug: itraconazole||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Trial of Itraconazole Pharmacokinetics in Patients With Metastatic Breast Cancer|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||March 2012|
Patients will receive oral itraconazole 200mg a day until disease progression.
oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
- Pharmacokinetics (PK) of Oral Itraconazole [ Time Frame: pre-dose at Weeks 2 and 4 ]To determine the pharmacokinetics (PK) of oral itraconazole in patients with MBC by measuring mean trough plasma levels at steady state at weeks 2 and 4.
- Number of Patients With Adverse Events Grade 3 or 4 That Are Related to Study Treatment [ Time Frame: up to 100 months ]Number of patients with Adverse Events grade 3 or 4 that are related to study treatment. This will look into the safety of the study drug.
- Time to Progression. [ Time Frame: up to 100 months ]This is calculated as time till progression from treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months. If a patient did not progress, they were censored at the last evaluation visit. The median time till progression is calculated with its 95% confidence interval.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00798135
|United States, Indiana|
|Indiana University Melvin and Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Kathy Miller, MD||Indiana University Melvin and Bren Simon Cancer Center|