Study of Artesunate in Metastatic Breast Cancer
Phase 1
Completed
- Conditions
- Locally Advanced Breast CancerMetastatic Breast Cancer
- Interventions
- Registration Number
- NCT00764036
- Lead Sponsor
- Heidelberg University
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 23
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description experimental arm only artesunate add-on therapy with 100, 150 or 200 mg oral artesunate once daily
- Primary Outcome Measures
Name Time Method Dose limiting adverse events with possible, probable or definite relation with the respective dose level of the add-on therapy 8-12 weeks
- Secondary Outcome Measures
Name Time Method Adverse events relation between adverse events and add-on therapy, cortisol profile in saliva, overall response rate, clinical benefit, assessment of patients expectations 8-12 weeks
Trial Locations
- Locations (1)
Complementary and Integrative Medicine, Dep. Gyn. Endocrinology, Women's Hospital, University of Heidelberg
🇩🇪Heidelberg, Baden-Württemberg, Germany