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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00764036
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : August 1, 2017
Sponsor:
Collaborators:
Hector-Stiftung
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

Tracking Information
First Submitted Date  ICMJE September 30, 2008
First Posted Date  ICMJE October 1, 2008
Last Update Posted Date August 1, 2017
Actual Study Start Date  ICMJE October 2008
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2008)
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 ]
Current Other Pre-specified Outcome Measures
 (submitted: March 28, 2017)
  • 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 ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Artesunate in Metastatic Breast Cancer
Official Title  ICMJE 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
Brief Summary 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.
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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Intervention Model Description:
dose escalation
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Breast Cancer
  • Locally Advanced Breast Cancer
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: experimental arm only
add-on therapy with 100, 150 or 200 mg oral artesunate once daily
Intervention: Drug: artesunate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2017)
23
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2008)
18
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00764036
Other Study ID Numbers  ICMJE M33/2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cornelia von Hagens, Heidelberg University
Study Sponsor  ICMJE Heidelberg University
Collaborators  ICMJE
  • Hector-Stiftung
  • Dafra Pharma
  • Monika-Kutzner Stiftung, Berlin, Germany
  • HEIFAN-Heidelberger Förderverein d. Ambulanz f. Naturheilkunde eV, Heidelberg, Germany
Investigators  ICMJE
Principal Investigator: Cornelia U v. Hagens, MD Department of Gynecological Endocrinology and Reproductive Medicine
PRS Account Heidelberg University
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP