Study of Artesunate in Metastatic Breast Cancer
Ключевые слова
абстрактный
Описание
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)
Даты
| Последняя проверка: | 06/30/2017 |
| Первый отправленный: | 09/29/2008 |
| Предполагаемая регистрация отправлена: | 09/29/2008 |
| Первое сообщение: | 09/30/2008 |
| Последнее обновление отправлено: | 07/27/2017 |
| Последнее обновление опубликовано: | 07/31/2017 |
| Фактическая дата начала исследования: | 09/30/2008 |
| Предполагаемая дата завершения начальной школы: | 10/31/2013 |
| Предполагаемая дата завершения исследования: | 10/31/2013 |
Состояние или болезнь
Вмешательство / лечение
Drug: experimental arm only
Фаза
Группы рук
| Рука | Вмешательство / лечение |
|---|---|
| Experimental: experimental arm only add-on therapy with 100, 150 or 200 mg oral artesunate once daily | Drug: experimental arm only add-on therapy with daily single oral doses of 100, 150 or 200 mg of artesunate |
Критерии приемлемости
| Возраст, имеющий право на обучение | 18 Years Чтобы 18 Years |
| Полы, имеющие право на обучение | Female |
| Принимает здоровых добровольцев | да |
| Критерии | 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 |
Результат
Основные показатели результатов
1. Dose limiting adverse events with possible, probable or definite relation with the respective dose level of the add-on therapy [8-12 weeks]
Меры вторичного результата
1. Adverse events relation between adverse events and add-on therapy, cortisol profile in saliva, overall response rate, clinical benefit, assessment of patients expectations [8-12 weeks]
Другие показатели результатов
1. Further safety data (adverse events) during prolonged treatments latest till the second progression during the add-on therapy with the study medication (compassionate use) [add-on treatments > 4+/- 1 weeks]
2. Collection of further safety data during later individual compassionate use with monitoring if approbriate for the patients' health status [Depending on patients' preference and health status]
