EUCTR2014-005016-42-IT进行中（未招募）不适用
Multicenter, prospective, open label study , in patients with non small celllung cancer (NSCLC), stage IIIB / IV or recurrent, after the failure of firstline chemotherapy in which it's possible a treatment that evaluates theeffectiveness and the safety of oral BIBF 1120 in combination withstandard docetaxel therapy, which can be administered (at the discretionof the referring physician) with tri-weekly or weekly schedule
Dipartimento di Oncologia-Università degli studi di Torino0 个研究点目标入组 180 人开始时间: 2015年3月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
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
- •patients> 18 years; ECOG PS 0-1; disease stage IIIB / IV according to
- •the classification RECIST 1.1 with a cytotoxic or histo-logical diagnosis
- •of NSCLC (non-squamous) and who have previously received only
- •chemotherapy (except for treatment neo-adjuvant or adjuvant, from
- •which must be spent at least 12 months compared to study entry); the
- •presence of at least one measurable lesion according to RECIST (version
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •are excluded patients with a previous diagnosis of oncologic pathology ,
- •except for non-melanoma skin cancers, carcinoma in situ of the cervix or
- •other forms of cancer from which the patient must, however, be free
- •from at least 3 years prior to study enrollment; patients with known
- •positivity for molecular studies such as EGFR and ALK; previous
- •treatment with TKIs or inhibitors of ALK; presence of brain metastases
- •unstable (defined as stable if spent four weeks from a previous radiation
- •therapy); previous chemotherapy with docetaxel or VEGFR inhibitors
- •(except for Avastin, which is allowed by the study); more than one line
- •of chemotherapy treatment (with the exception above to neoadjuvant or
- •adjuvant treatment); persistent and non-hematological toxicities in
- •reference to previous treatments carried out; presence of cavitations in
- •the lung or evidence on CT or MRI of tumors central or local invasion of
- •the major vessels, or a recent history (<3 months) of hemoptysis or
- •bleeding or thrombotic event more important in the previous six months;
- •anticoagulant therapy (except heparin bpm) or antiplatelet therapy
- •(except aspirin dosage <325mg daily); significant cardiac disease
- •(unstable angina, myo
研究者
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