A Pilot Trial of Itraconazole Pharmacokinetics in Patients With Metastatic Breast Cancer
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Trial of Itraconazole Pharmacokinetics in Patients With Metastatic Breast Cancer|
- Pharmacokinetics (PK) of Oral Itraconazole [ Time Frame: pre-dose at Weeks 2 and 4 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||February 2015|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Patients will receive oral itraconazole 200mg a day until disease progression.
oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
Please refer to this study by its ClinicalTrials.gov identifier: 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|