Title
Study of Artesunate in Metastatic Breast Cancer
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
Phase
Phase 1Lead Sponsor
University of HeidelbergStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Metastatic Breast Cancer Locally Advanced Breast CancerIntervention/Treatment
artesunate ...Study Participants
23The 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.
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)
add-on therapy with daily single oral doses of 100, 150 or 200 mg of artesunate
add-on therapy with 100, 150 or 200 mg oral artesunate once daily
Inclusion Criteria: Patients with histologically or cytologically confirmed breast cancer Distant metastases or locally advanced breast cancer Age ≥ 18 years ECOG performance ≤ 2 Life expectancy of at least 6 months Written informed consent individual standard therapy according to guidelines Oral intake of trial medication possible Compliance with study procedures Women of childbearing potential: negative pregnancy test before start of medication Use of a highly effective method of birth control during intake of add-on therapy for women of childbearing potential being sexually active Inclusion Criteria for Extended Treatment Phase: Participant of the phase I study ARTIC M33/2 who had tolerated the study medication for 4±1 weeks without clinically relvant adverse events or after improvement to ≤ grade 2 Participant of the phase I study ARTIC M33/2 with possible benefit by continuation or restart of the add-on therapy after a next progression according to current scientific knowledge Written informed consent for extended treatment phase Consent of the responsible oncologist Compliance for further intake and follow-up expected Inclusion Criteria for Individual Compassionate Use: Participant of the phase I study ARTIC M33/2 Available standard therapies have minimal or only short activity or intolerable side effects Written informed consent for compassionate use Consent of the responsible oncologist Exclusion Criteria: Allergy to artesunate or to other artemisinin derivatives Concurrent conditions interfering with patient safety Communication problems Concurrent participation in another clinical trial or 4 weeks prior to recruitment Participation in a clinical trial with an unapproved drug 6 months prior to recruitment Sinus bradycardia, bradyarrhythmia AV-Block II° and III° QTc > 500 msec Previously known long QT-syndrome Concurrent intake of a medication with clinically relevant neurotoxicity or during 30 days prior to recruitment Relevant neurological symptoms which might complicate the evaluation of the compatibility of the IMPD (f. e. cerebral metastases) or might be subject to worsening during intake of the IMPD Radiotherapy 2 weeks prior of the intake of the IMPD Concurrent intake of supplements or any other medication with unapproved efficacy f.e. vitamins, minerals or others (OTC) Pregnancy and lactation Ineffective mode of contraception in women of childbearing potential Exclusion Criteria for Extended Treatment Phase: Clinically relevant adverse Events during the first 4 weeks of intake of study medication possibly, probably or definitely related to the study medication Intolerable health risks by continuation re-exposition with the study medication Continuation or re-exposition is medically not acceptable after consultation of physicians responsible for their standard therapy Exclusion Criteria for Individual Compassionate Use: - Intolerable health risks by re-exposition with the study medication