EUCTR2007-004803-36-PT进行中（未招募）1 期
Multicentre, randomised, double-blind, Phase III trial to investigate the efficacy and safety of oral BIBF 1120 plus standard docetaxel therapy compared to placebo plus standard docetaxel therapy in patients withstage IIIB/IV or recurrent non small cell lung cancer after failure of first line chemotherapy - BIBF 1120 plus docetaxel in 2nd line NSCLC
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,300
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
- •male or female patient aged 18 years or older
- •histologically or cytologically confirmed, locally advanced and/or metastatic NSCLC of stage IIIB or IV (according to American Joint Committee on Cancers) or recurrent
- •NSCLC (all histologies)
- •relapse or failure of one first line prior chemotherapy (in the case of recurrent disease one additional prior regimen is allowed for adjuvant, neoadjuvant or neoadjuvant plus adjuvant therapy)
- •at least one target tumour lesion that has not been irradiated within the past three months and that can accurately be measured by magnetic resonance imaging (MRI) or computed tomography (CT) in at least one dimension (longest diameter to be recorded) as = 20 mm with conventional techniques or as = 10 mm with spiral CT
- •life expectancy of at least three months
- •ECOG score of 0 or 1
- •patient has given written informed consent which must be consistent with international conference on harmonisation – good clinical practice (ICH-GCP) and local legislation
- •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 900
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •more than one prior chemotherapy regimen for advanced and/or metastatic disease or recurrent NSCLC
- •more than one chemotherapy treatment regimen prior to first line chemotherapy of advanced and/or metastatic or recurrent NSCLC
- •previous therapy with other VEGFR inhibitors (other than bevacizumab) or docetaxel for treatment of NSCLC
- •persistence of clinically relevant therapy related toxicities from previous chemotherapy and/or radiotherapy
- •treatment with other investigational or anti-cancer drugs or treatment in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial
- •radiotherapy (except extremities and brain) within the past three months prior to baseline imaging
- •active brain metastases
- •radiographic evidence of cavitary or necrotic tumours
- •centrally located tumours with radiographic evidence (CT or MRI) of local invasion of major blood vessels
- •history of clinically significant haemoptysis within the past 3 months, therapeutic anticoagulation (except low dose heparin) or antiplatelet therapy, history of major thrombotic or clinically relevant major bleeding event in the past 6 months, known inherited predisposition to bleeding or thrombosis
- •significant cardiovascular disease
- •inadequate safety laboratory parameters
- •significant weight loss (> 10 %) within the past 6 weeks prior to treatment in the present trial
- •current peripheral neuropathy = CTCAE grade 2 except due to trauma
- •preexisting ascites and/or clinically significant pleural effusion
- •major injuries and/or surgery within the past ten days prior to randomisation with incomplete wound healing
- •serious illness, active infections requiring systemic antimicrobial therapy or concomitant non-oncological disease
- •patients unwilling to use a medically acceptable contraception
- •pregnancy or breast feeding
- •psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol
- •patients unable to comply with the protocol
- •active alcohol or drug abuse
- •other malignancy within the past three years other than basal cell skin cancer, or carcinoma in situ of the cervix
- •any contraindications for therapy with docetaxel
- •history of hypersensitivity to docetaxel, polysorbate 80 (Tween 80), BIBF 1120, contrast media
研究者
相似试验
进行中（未招募）
1 期
ME-Lung 1: BIBF 1120 plus docetaxel as compared to placebo plus docetaxel in 2nd line non small cell lung cancerEUCTR2007-004803-36-BEBoehringer Ingelheim International GmbH1,300
进行中（未招募）
1 期
Multicentre, randomised, double-blind, Phase III trial to investigate theefficacy and safety of oral BIBF 1120 plus standard docetaxel therapycompared to placebo plus standard docetaxel therapy in patients withstage IIIB/IV or recurrent non small cell lung cancer after failure of firstline chemotherapy - BIBF 1120 plus docetaxel in 2nd line NSCLCstage IIIB/IV or recurrent non small cell lung cancer after failure of firstline chemotherapyMedDRA version: 9.1Level: LLTClassification code 10066490Term: Progression of non small cell lung cancerEUCTR2007-004803-36-FRBoehringer Ingelheim International GmbH1,300
进行中（未招募）
1 期
ME-Lung 1: BIBF 1120 plus docetaxel as compared to placebo plus docetaxel in 2nd line non small cell lung cancerStage IIIB/IV or recurrent non small cell lung cancer after failure of first line chemotherapyMedDRA version: 16.1Level: LLTClassification code 10066490Term: Progression of non-small cell lung cancerSystem Organ Class: 100000004864EUCTR2007-004803-36-BGBoehringer Ingelheim International GmbH1,300
进行中（未招募）
1 期
Multicentre, randomised, double-blind, Phase III trial to investigate theefficacy and safety of oral BIBF 1120 plus standard docetaxel therapycompared to placebo plus standard docetaxel therapy in patients withstage IIIB/IV or recurrent non small cell lung cancer after failure of firstline chemotherapy - BIBF 1120 plus docetaxel in 2nd line NSCLCstage IIIB/IV or recurrent non small cell lung cancer after failure of firstline chemotherapyMedDRA version: 9.1Level: LLTClassification code 10066490Term: Progression of non small cell lung cancerEUCTR2007-004803-36-SKBoehringer Ingelheim International GmbH1,300
进行中（未招募）
1 期
ME-Lung 1: BIBF 1120 plus docetaxel as compared to placebo plus docetaxel in 2nd line non small cell lung cancerstage IIIB/IV or recurrent non small cell lung cancer after failure of firstline chemotherapyMedDRA version: 17.0Level: LLTClassification code 10066490Term: Progression of non-small cell lung cancerSystem Organ Class: 100000004864EUCTR2007-004803-36-DEBoehringer Ingelheim International GmbH1,300