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

This study has been completed.
H. W. & J. Hector-Stiftung, Weinheim
Dafra Pharma
Monika-Kutzner Stiftung, Berlin, Germany
HEIFAN-Heidelberger Förderverein d. Ambulanz f. Naturheilkunde eV, Heidelberg, Germany
Information provided by (Responsible Party):
Cornelia von Hagens, Heidelberg University Identifier:
First received: September 30, 2008
Last updated: March 28, 2017
Last verified: March 2017
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.

Condition Intervention Phase
Metastatic Breast Cancer
Locally Advanced Breast Cancer
Drug: artesunate
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Sequential Assignment
Intervention Model Description:
dose escalation
Masking: No masking
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Dose limiting adverse events with possible, probable or definite relation with the respective dose level of the add-on therapy [ Time Frame: 8-12 weeks ]

Secondary Outcome Measures:
  • Adverse events relation between adverse events and add-on therapy, cortisol profile in saliva, overall response rate, clinical benefit, assessment of patients expectations [ Time Frame: 8-12 weeks ]

Other Outcome Measures:
  • Further safety data (adverse events) during prolonged treatments latest till the second progression during the add-on therapy with the study medication (compassionate use) [ Time Frame: add-on treatments > 4+/- 1 weeks ]
  • Collection of further safety data during later individual compassionate use with monitoring if approbriate for the patients' health status [ Time Frame: Depending on patients' preference and health status ]

Enrollment: 23
Actual Study Start Date: October 2008
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: experimental arm only
add-on therapy with 100, 150 or 200 mg oral artesunate once daily
Drug: artesunate
add-on therapy with daily single oral doses of 100, 150 or 200 mg of artesunate
Other Names:
  • artesunic acid hemisuccinate
  • dihydroqinghaosu hemisuccinate

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)

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00764036

Complementary and Integrative Medicine, Dep. Gyn. Endocrinology, Women's Hospital, University of Heidelberg
Heidelberg, Baden-Württemberg, Germany, D-69120
Sponsors and Collaborators
Heidelberg University
H. W. & J. Hector-Stiftung, Weinheim
Dafra Pharma
Monika-Kutzner Stiftung, Berlin, Germany
HEIFAN-Heidelberger Förderverein d. Ambulanz f. Naturheilkunde eV, Heidelberg, Germany
Principal Investigator: Cornelia U v. Hagens, MD Department of Gynecological Endocrinology and Reproductive Medicine
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cornelia von Hagens, Head Complementary & Integrative Medicine, Dep. 4.2, Heidelberg University Identifier: NCT00764036     History of Changes
Other Study ID Numbers: M33/2
Study First Received: September 30, 2008
Last Updated: March 28, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Heidelberg University:
phase I

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials processed this record on April 28, 2017