Phase I Study of Artesunate in Cancer - Full Text View

Phase I Study of Artesunate in Cancer (ARTIC-M33/2)

This study is currently recruiting participants.

Verified by University of Heidelberg, October 2008

Sponsors and Collaborators:	University of Heidelberg H. W. & J. Hector-Stiftung, Weinheim Faculty of Medicine, University of Heidelberg Dafra Pharma Research & Development BVBA
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00764036

Purpose

The purpose of this study is the evaluation of the tolerability of an add-on therapy with artesunate with a duration of 4 weeks in patients with advanced cancer.

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

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Artesunate Artemisinin Dihydroquinghaosu

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

Further study details as provided by University of Heidelberg:

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:	18
Study Start Date:	October 2008
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Intervention Details:

add-on therapy with daily single oral doses of 100, 150 or 200 mg of artesunate

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 firt 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

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

Contacts

Contact: Cornelia U v. Hagens, MD	00496221-56 ext 8321	cornelia.von.hagens@med.uni-heidelberg.de
Contact: Julia E Osburg, MD	00496221-56 ext 8312	julia.osburg @med.uni-heidelberg.de

Locations

Germany, Baden-Württemberg
Complementary and Integrative Medicine, Dep. Gyn. Endocrinology, Women's Hospital, University of Heidelberg	Recruiting
Heidelberg, Baden-Württemberg, Germany, D-69115
Contact: Andrea Mallok, SN 0049-6221-56 ext 8321 andrea.mallok@med.uni-heidelberg.de
Sub-Investigator: Anita Glenz, MD

Sponsors and Collaborators

University of Heidelberg

H. W. & J. Hector-Stiftung, Weinheim

Faculty of Medicine, University of Heidelberg

Dafra Pharma Research & Development BVBA

Investigators

Principal Investigator:

Cornelia U v. Hagens, MD

Department of Gynecological Endocrinology and Reproductive Medicine

More Information

Responsible Party:	Complementary&Integrative Med., Dep. 4.2, University Women's Hospital Heidelberg ( Dr. med. Cornelia von Hagens )
Study ID Numbers:	M33/2, EUDRACT 2007-004432-23
Study First Received:	September 30, 2008
Last Updated:	November 19, 2008
ClinicalTrials.gov Identifier:	NCT00764036
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Heidelberg:

phase I
safety

Study placed in the following topic categories:

Artesunate
Artemisinins
Skin Diseases
Artemisinine

Breast Neoplasms
Dihydroquinghaosu
Marijuana Abuse
Breast Diseases

Additional relevant MeSH terms:

Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Neoplasms

Neoplasms by Site
Therapeutic Uses
Amebicides
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009