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

July 28, 2017 updated by: Cornelia von Hagens, Heidelberg University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

23

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, D-69120
        • Complementary and Integrative Medicine, Dep. Gyn. Endocrinology, Women's Hospital, University of Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
8-12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
8-12 weeks

Other Outcome Measures

Outcome Measure
Time Frame
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
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
Depending on patients' preference and health status

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Collaborators

Dafra Pharma
Hector-Stiftung
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2008

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

September 30, 2008

First Submitted That Met QC Criteria

September 30, 2008

First Posted (Estimate)

October 1, 2008

Study Record Updates

Last Update Posted (Actual)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 28, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M33/2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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