EUCTR2016-002093-12-GB进行中（未招募）1 期
A Phase II multicenter study comparing the efficacy of the oral angionenesis inhibitor nintedanib with the intravenous cytotoxis compound ifosfamide for treatment of patients with advanced metastatic soft tissue sarcoma after failure of systemic non-oxazaphosporine-based first line chemotherapy for inoperable disease ANITA
European Organisation for Research and Treatment of Cancer0 个研究点目标入组 158 人开始时间: 2017年3月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 158
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •? Histologically proven advanced, inoperable (medical or surgical) and/or metastatic malignant STS of intermediate or high grade
- •? Representative formalin fixed, paraffin embedded tumor blocks or unstained tissue slides, either from the primary tumor or a metastatic lesion, must be available for histological central review. Histological central review is not required before treatment start but it is mandatory to send unstained tumor slides (blocks optional) at time of study entry. Local histopathological diagnosis will be accepted for entry into this trial.
- •? Prior to study enrolment, all patients need to have confirmed RECIST 1.1 disease progression based on local investigator's assessment.
- •? Presence of measurable disease according to RECIST 1.1.
- •?One (and no less or more than one) line of previous systemic chemotherapy for advanced, inoperable and/or metastatic malignant STS.
- •? Note: Patients treated in first line with doxorubicin/olaratumab or
- •doxorubicin/placebo +/- olaratumab/placebo maintenance qualify for the trial and such treatment will be considered as one line according to the protocol.
- •? Age 18 years or older
- •? WHO performance status (PS) 0-2.
- •? Life expectancy of at least 3 months.
- •? Adequate bone marrow, liver and renal function and coagulation parameters
- •? Normal cardiac function, 12 lead electrocardiogram without clinically relevant abnormalities. No Class III or IV congestive heart failure, angina pectoris, myocardial infarction within 1 year before registration/randomization, clinically significant cardiac arrhythmia or pericardial effusion.
- •?Absence of active or uncontrolled infections in particular if requiring systemic antibiotics or antimicrobial therapy.
- •? Absence of serious illnesses or medical conditions, including a history of chronic alcohol abuse, active and chronic hepatitis B or C, chronic infection with HIV or clinically relevant liver cirrhosis.
- •? Absence of active gastrointestinal disorders or abnormalities that interfere with absorption of the study drug.
- •? Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration/randomization in the trial.
- •? Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours prior to randomization.
- •? Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and after the last study treatment as follows:
- •? Nintedanib: for at least 3 months after the last dose
- •? Ifosfamide: for at least 1 year after the last dose
- •? A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. Such methods include:
- •? Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal).
- •? Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable).
- •? Intrauterine device (IUD)
- •? Intrauterine hormone-releasing system (IUS)
- •? Bilateral tubal occlusion
- •? Vasectomised partner
- •? Sexual abstinence (not accepted for Switzerland)
- •Since the effe
排除标准
- •?History of central nervous system metastasis or leptomeningeal tumor spread.
- •?Active brain metastases
- •?Other anti-cancer therapy within 28 days prior to randomization.
- •?Treatment with another investigational agent within 28 days prior to randomization.
- •?Treatment with another investigational agent concomitantly with the trial.
- •?Known hypersensitivity to or known specific contraindications for the use of nintedanib or ifosfamide.
- •?Known hypersensitivity to peanut or soy bean.
- •?Child Pugh B or C hepatic impairment.
- •?Uncontrolled arterial hypertension defined at baseline as blood pressure = 150/100 mmHg despite adequate medical therapy.
- •?Use of therapeutic anticoagulation or anti-platelet therapy
- •?Known inherited predisposition for bleeding or thromboembolism.
- •?History of clinically significant hemorrhagic or thromboembolic event in the past 6 months.
- •?previous encephalopathy of any cause or other significant neurological condition.
- •?acute or chronic, clinically relevant inflammation of urinary bladder.
- •?major injuries and/or surgery within the past 28 days prior to randomization with incomplete wound healing and/or planned surgery during the on-treatment study period.
- •?persistence of clinically relevant therapy-related toxicity from previous chemotherapy and/or radiotherapy. Grade 1 or 2 adverse events (AEs) are acceptable.
- •?history, within the past five years, of malignancies other than STS
- •?active alcohol or drug abuse.
研究者
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