EUCTR2011-005814-12-GB进行中（未招募）1 期
Phase II, randomised, placebo controlled, multicentre, feasibility study of low dose (metronomic) cyclophosphamide with or without nintedanib (BIBF 1120) in advanced ovarian cancer (METRO-BIBF) - Low dose cyclophosphamide +/- nintedanib in advanced ovarian cancer
niversity College London0 个研究点目标入组 117 人开始时间: 2013年7月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 117
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
入选标准
- •- Female subjects, >18 years, histologically proven recurrent advanced epithelial ovarian, fallopian tube or primary peritoneal carcinomas
- •- Have either undergone a hysterectomy or bilateral oophorectomy/salpingectomy and/or have been postmenopausal for 24 consecutive months (i.e. who have not had menses at any time in the preceding 24 consecutive months without an alternative medical cause).
- •- Performance status 0-2
- •- Adequate organ function
- •- Life expectancy > 6 weeks
- •- Has received 2 or more lines of chemotherapy for ovarian cancer and patient is platinum resistant or platinum intolerant or not suitable for any further standard intravenous chemotherapy
- •- No previous oral cyclophosphamide, nintedanib, or other tyrosine kinase inhibitors such as cediranib but patients can have received anti-VEGF therapies such as bevacizumab as they will be stratified for this.
- •- Measurable lesions according to RECIST 1.1 criteria or serum CA125 levels for evaluation by GCIG CA125 criteria are welcomed but not a prerequisite for inclusion as response will only be assessed for those with evaluable disease.
- •- Able to give written informed consent and to complete QoL
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 62
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 62
排除标准
- •- Carcinosarcoma or malignant tumour of non-epithelial origin (e.g. germ cell tumour, sex cord-stromal tumour) of the ovary, fallopian tube or peritoneum
- •- Clinically relevant non-healing wound, ulcer (intestinal tract, skin) or bone fracture
- •- Symptoms or signs of gastrointestinal obstruction requiring parenteral nutrition or hydration or any other GI disorders or abnormalities that would interfere with drug absorption or inability to take oral medication
- •- Active brain metastases (i.e. symptoms deteriorating, changing condition in < 4 weeks) or leptomeningeal disease. Trial entry is allowed if the brain metastases are stable (asymptomatic or condition stable for > 4 weeks). Dexamethasone for brain metastases is allowed if administered as stable dose for > 4 weeks before randomisation (if < 4 weeks the patient is not eligible)
- •- Clinically relevant therapy-related toxicity from previous chemotherapy and radiotherapy
- •- History of major thromboembolic event within last 6 months, such as pulmonary embolism or proximal deep vein thrombosis, unless on stable therapeutic anticoagulation (>3 months if on warfarin, PT / INR needs to be monitored regularly)
- •- Known inherited or acquired bleeding disorder
- •- Significant cardiovascular diseases, including uncontrolled hypertension, clinically relevant cardiac arrhythmia, unstable angina or myocardial infarction within the past 6 months, congestive heart failure > NYHA II, severe peripheral vascular disease, significantly relevant pericardial effusion
- •- History of a cerebral vascular accident, transient ischemic attack or subarachnoid hemorrhage within the past 6 months
- •- radiographic evidence of cavitating or necrotic tumours with invasion of adjacent major blood vessels.
- •Laboratory values at baseline indicating an increased risk for adverse events:
- •a.calculated GFR < 45 ml/min. Sites can use any calculation method according to local practice.
- •b.absolute neutrophil count (ANC) <1.5 x 109/L
- •c.platelets <100 x 109/L
- •d.haemoglobin < 90 g/L
- •e.proteinuria CTCAE 2 or greater
- •f.total bilirubin higher than twice ULN
- •g.ALT and/or AST > 1.5 x ULN unless liver metastases present when ALT / AST > 2.5 ULN
- •h. International normalized ratio (INR)>2, prothrombin time (PT) and activated partial thromboplastin time (APPT) > 1.5 x ULN in the absence of therapeutic anticoagulation
- •- Serious infections in particular if requiring systemic antibiotic (antimicrobial, antifungal or antiviral therapy), including active or chronic hepatitis B and/or C infection, HIV- infection
- •- Poorly controlled diabetes mellitus
- •- Previous breast cancer patients are permitted only if diagnosis and any chemotherapy treatment for this was > 5 years previously and there is no evidence of metastatic breast cancer at trial entry (Please contact UCL CTC / CI if patient still on hormone treatment for breast cancer).
- •- Other malignancy diagnosed within the past 5 years. In exception to this rule, the following malignancies may be included:
- •(a) non-melanoma skin cancer (if adequately treated)
- •(b) cervical carcinoma in situ (if adeq
研究者
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