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
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
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose limiting adverse events with possible, probable or definite relation with the respective dose level of the add-on therapy
8-12 weeks
Yes
Cornelia U v. Hagens, MD
Principal Investigator
Department of Gynecological Endocrinology and Reproductive Medicine
Germany: Federal Institute for Drugs and Medical Devices
M33/2
NCT00764036
October 2008
September 2011
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