Study of Artesunate in Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heidelberg University
• Collaborators: Dafra Pharma; Dafra Pharma Research & Development BVBA; H. W. & J. Hector-Stiftung, Weinheim; Hector-Stiftung; HEIFAN-Heidelberger Förderverein d. Ambulanz f. Naturheilkunde eV, Heidelberg, Germany; Monika-Kutzner Stiftung, Berlin, Germany
• Treatments: Artemisinins; Artesunate

Criteria

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