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

This study has been completed.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT00764036
First received: September 30, 2008
Last updated: March 28, 2017
Last verified: March 2017
  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: 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)
  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes 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

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
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-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
Investigators
Principal Investigator: Cornelia U v. Hagens, MD Department of Gynecological Endocrinology and Reproductive Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cornelia von Hagens, Head Complementary & Integrative Medicine, Dep. 4.2, Heidelberg University
ClinicalTrials.gov 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
safety

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Artesunate
Artemisinins
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials

ClinicalTrials.gov processed this record on April 28, 2017