NCT00764036已完成1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Dose limiting adverse events with possible, probable or definite relation with the respective dose level of the add-on therapy
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
experimental arm only
Experimental
add-on therapy with 100, 150 or 200 mg oral artesunate once daily
干预措施: artesunate (Drug)
结局指标
主要结局
Dose limiting adverse events with possible, probable or definite relation with the respective dose level of the add-on therapy
时间窗: 8-12 weeks
次要结局
- 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)
研究者
Cornelia von Hagens
Head Complementary & Integrative Medicine, Dep. 4.2
Heidelberg University
研究点 (1)
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