Overview

This trial is active, not recruiting.

Conditions metastatic breast cancer, locally advanced breast cancer
Treatment artesunate
Phase phase 1
Sponsor Heidelberg University
Collaborator H. W. & J. Hector-Stiftung, Weinheim
Start date October 2008
End date August 2011
Trial size 30 participants
Trial identifier NCT00764036, EUDRACT 2007-004432-23, M33/2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
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 Outcomes

Measure
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

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

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
Principal investigator Cornelia U v. Hagens, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by Heidelberg University.