Study of Artesunate in Metastatic Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2013-11-30

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Metastatic Breast Cancer Locally Advanced Breast Cancer

Study Design

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Intervention Model

SEQUENTIAL

dose escalation

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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experimental arm only

add-on therapy with 100, 150 or 200 mg oral artesunate once daily

Group Type EXPERIMENTAL

artesunate

Intervention Type DRUG

add-on therapy with daily single oral doses of 100, 150 or 200 mg of artesunate

Interventions

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artesunate

add-on therapy with daily single oral doses of 100, 150 or 200 mg of artesunate

Intervention Type DRUG

Other Intervention Names

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artesunic acid hemisuccinate dihydroqinghaosu hemisuccinate

Eligibility Criteria

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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

* 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

* 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

* 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

\- Intolerable health risks by re-exposition with the study medication

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No