N/A
Completed N=13
A Pilot Trial of Itraconazole Pharmacokinetics in Patients With Metastatic Breast Cancer
Breast Neoplasms · Neoplasm Metastasis
Source: ClinicalTrials.gov NCT00798135 ↗
Enrolled (actual)
13
Serious AEs
23.1%
Results posted
Sep 2014
Primary outcomePrimary: Pharmacokinetics (PK) of Oral Itraconazole — 230.7; 305.8; 454.8; 501.6 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK) of Oral Itraconazole |
230.7; 305.8; 454.8; 501.6 | — |
| SECONDARY Number of Patients With Adverse Events Grade 3 or 4 That Are Related to Study Treatment |
2 | — |
| SECONDARY Time to Progression. |
1.54 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have a pathologically confirmed diagnosis of invasive carcinoma of the breast. - Patients must carry a diagnosis of metastatic breast cancer. - Patients must be able to swallow oral medications. - Patients with HER 2+ tumors must have received trastuzumab in the past and may have had lapatinib. - Patients must have an ECOG performance status of 0-1. - Patients must be informed of the investigational nature of the study and must sign and give written informed consent. - Patients must have recovered to grade = 1,500 mm3 2) Platelet count >= 100,000 mm3 3) Bilirubin 160/90) for cardiac dysfunction but no preexisting diagnosis of congestive heart failure or left ventricular dysfunction will have a screening EKG prior to enrollment. Subsequently, those patients with an abnormal EKG, as judged by the treating physician, will be excluded from the study.
Data sourced from ClinicalTrials.gov (NCT00798135). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.