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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Heidelberg University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
H. W. & J. Hector-Stiftung, Weinheim
Dafra Pharma Research & Development BVBA
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00764036
First received: September 30, 2008
Last updated: July 14, 2011
Last verified: February 2009
  Purpose

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: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: October 2008
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764036

Locations
Germany
Complementary and Integrative Medicine, Dep. Gyn. Endocrinology, Women's Hospital, University of Heidelberg
Heidelberg, Baden-Württemberg, Germany, D-69115
Sponsors and Collaborators
Heidelberg University
H. W. & J. Hector-Stiftung, Weinheim
Dafra Pharma Research & Development BVBA
Investigators
Principal Investigator: Cornelia U v. Hagens, MD Department of Gynecological Endocrinology and Reproductive Medicine
  More Information

No publications provided

Responsible Party: Dr. med. Cornelia von Hagens, Complementary&Integrative Med., Dep. 4.2, University Women's Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT00764036     History of Changes
Other Study ID Numbers: M33/2, EUDRACT 2007-004432-23
Study First Received: September 30, 2008
Last Updated: July 14, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heidelberg University:
phase I
safety

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Artesunate
Dihydroquinghaosu
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials

ClinicalTrials.gov processed this record on July 23, 2014