Spots Global Cancer Trial Database for Study of Artesunate in Metastatic Breast Cancer
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Trial Identification
Brief Title: Study of Artesunate in Metastatic Breast Cancer
Official Title: Prospective Open Uncontrolled Phase I Study of Compatibility, Safety&Pharmacokinetics of Artesunate, a Semisynthetic Derivative of Artemisinin From the Chinese Herb Artemisia Annua in Patients With Metastatic/Locally Advanced Breast Cancer
Study ID: NCT00764036
Interventions
Study Description
Brief Summary: The purpose of this study is to evaluation the tolerability of an add-on therapy with artesunate with a duration of 4 weeks in patients with advanced breast cancer.
Detailed Description: Additional objectives are: * parallel sampling of blood and saliva for the determination of drug concentrations and pharmacokinetic parameters in a substudy on the day of first application and during steady state * attempt to establish a therapeutical drug monitoring * collection of further safety data during prolonged add-on treatments (compassionate use)
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Complementary and Integrative Medicine, Dep. Gyn. Endocrinology, Women's Hospital, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany
Contact Details
Name: Cornelia U v. Hagens, MD
Affiliation: Department of Gynecological Endocrinology and Reproductive Medicine
Role: PRINCIPAL_INVESTIGATOR
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