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 University of Heidelberg.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Heidelberg
Collaborators:
H. W. & J. Hector-Stiftung, Weinheim
Dafra Pharma Research & Development BVBA
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00764036
First received: September 30, 2008
Last updated: July 14, 2011
Last verified: February 2009
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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 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: | 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:
Detailed Description:
-
Drug: artesunate
- artesunic acid hemisuccinate
- dihydroqinghaosu hemisuccinate
add-on therapy with daily single oral doses of 100, 150 or 200 mg of artesunate
Other Names:
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
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
University of Heidelberg
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 University of Heidelberg:
|
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 May 19, 2013