Study of Artesunate in Metastatic Breast Cancer
This trial has been completed.
|Conditions||metastatic breast cancer, locally advanced breast cancer|
|Collaborator||H. W. & J. Hector-Stiftung, Weinheim|
|Start date||October 2008|
|End date||November 2013|
|Trial size||23 participants|
|Trial identifier||NCT00764036, M33/2|
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|
|Intervention model||sequential assignment|
|Intervention model description||dose escalation|
add-on therapy with 100, 150 or 200 mg oral artesunate once daily
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
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
Female participants from 18 years up to 99 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 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
|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 - collection of further safety data during prolonged add-on treatments (compassionate use)|
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