Study of Artesunate in Metastatic Breast Cancer (ARTIC-M33/2)

Heidelberg University

Status and phase

Completed

Phase 1

Conditions

Locally Advanced Breast Cancer

Metastatic Breast Cancer

Treatments

Drug: artesunate

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00764036

M33/2

Details and patient eligibility

About

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.

Full 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)

Enrollment

23 patients

Sex

Female

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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: