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Sponsored by: |
Indiana University School of Medicine |
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Information provided by: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00798135 |
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 | Intervention |
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Breast Neoplasms Neoplasm Metastasis |
Drug: itraconazole |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Pilot Trial of Itraconazole Pharmacokinetics in Patients With Metastatic Breast Cancer |
Estimated Enrollment: | 14 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate hematologic and hepatic function:
Exclusion Criteria:
United States, Indiana | |
Indiana University Melvin and Bren Simon Cancer Center | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Kathy Miller, M.D. 317-274-1690 kathmill@iupui.edu | |
Contact: LaTrice Vaughn, R.N. 317-278-3730 lgvaughn@iupui.edu |
Principal Investigator: | Kathy Miller, MD | Indiana University Melvin and Bren Simon Cancer Center |
Responsible Party: | Indiana University Melvin and Bren Simon Cancer Center ( Kathy Miller, MD/ Principal Investigator ) |
Study ID Numbers: | 0809-10; IUCRO-0239 |
Study First Received: | November 24, 2008 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00798135 |
Health Authority: | United States: Institutional Review Board |
Skin Diseases Clotrimazole Miconazole Tioconazole Neoplasm Metastasis |
Breast Neoplasms Hydroxyitraconazole Itraconazole Breast Diseases |
Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents Neoplastic Processes Neoplasms |
Pathologic Processes Neoplasms by Site Therapeutic Uses Antifungal Agents Pharmacologic Actions |