EUCTR2013-004324-11-NL进行中（未招募）1 期
Phase II study with oral fibroblast growth factor-1 inhibitor BIBF1120 as second line treatment in lung carcinoma patients harboring fibroblast growth factor receptor-1 gene amplification (NVALT-15 study) - NVALT-15
Stichting NVALT studies0 个研究点目标入组 76 人开始时间: 2014年3月12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
- 76
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
- •1.Stage IIIB or IV or recurrent NSCLC haboring a positive FISH for FGFR1 amplification (> 2 copies). Six unstained slides will be provided to the UMC Groningen to perform the test.
- •2.Age above 18 years.
- •3.Measurable tumor lesions (RECIST 1.1)
- •4.Life expectancy of at least 3 months.
- •5.Eastern Cooperative Oncology Group (ECOG) score of 0 - 1.
- •6.Patients who have sufficient baseline organ function and who meet the following criteria at the enrolment:
- •oAbsolute neutrophil count (ANC) = 1500/mm3;
- •oPlatelet count = 100 000/mm3;
- •oTotal bilirubin under the upper limit of normal (=upper limit of the local laboratory facility);
- •oAST/SGOT and/or ALT/GPT <=1.5 x upper limit of normal (if related to liver metastases <=2.5 x upper limit of normal);
- •oProteinuria Common Terminology Criteria for Adverse Events (CTCAE version 3.0) grade 1 or less;
- •oCalculated creatinine clearance by Cockcroft Gault = 45 mL/min;
- •oProthrombin time-international normalized ratio (PT-INR) and/or partial thromboplastin time (PTT) within normal limits;
- •oOxygen saturation by pulse-oximeter SpO2 = 92%;
- •7.Patient has given written informed consent which must be consistent with 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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •1.Patients who have received treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with this trial or who have not recovered from side effects of such therapy (except for alopecia).
- •2.Patients who have received chemo-, hormone-, immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks prior to treatment with the trial drug or who have not recovered from side effects of such therapy (except for alopecia).
- •3.Patients who have received radiotherapy on the target lesions within 4 weeks prior to treatment with the trial drug (in case of palliative radiotherapy such as for extremities, within 2 weeks prior to treatment with the trial drug).
- •4.Previous therapy with other vascular endothelial growth factor receptor (VEGFR) inhibitors or vascular endothelial growth factor (VEGF) ligand inhibitors for treatment of NSCLC.
- •5.Previous therapy with BIBF1120.
- •6.Patients who have symptomatic brain metastases or leptomeningeal disease.
- •7.Radiographic evidence of cavitation or necrotic tumors.
- •8.Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels.
- •9.History of clinically significant haemoptysis within the past 3 months.
- •10.Known inherited predisposition to bleeding or thrombosis.
- •11.Current peripheral neuropathy CTCAE version 3.0 grade 2 or greater except due to trauma.
- •12.Pre-existing ascites and/or clinically significant pleural effusion.
- •13.Major injuries and/or surgery within the past 4 weeks prior to treatment.
- •14.Clinically serious infections.
- •15.Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug.
- •16.Patients who have active or chronic hepatitis C and/or B infection and diagnosis of human immunodeficiency virus (HIV) infection.
- •17.Other malignancy other than basal cell skin cancer, carcinoma in situ or intra-mucosal cancer that were judged to be cured by adequate treatment and disease-free interval is more than 5 years.
- •18.History of serious drug hypersensitivity.
- •19.Serious illness or concomitant non-oncological disease such as neurologic-, psychiatric-, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation.
- •20.Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except acetylsalicylic acid up to 100 mg daily).
- •21.Patients who are sexually active and unwilling to use a medically acceptable method of contraception.
- •22.Pregnancy or breast feeding.
- •23.Patients unable to comply with the protocol.
研究者
相似试验
已完成
2 期
Phase II study with oral fibroblast growth factor-1 inhibitor BIBF1120 as treatment in lung carcinoma patients harboring fibroblast growth factor receptor-1 gene amplification (NVALT-15 study)NSCLClung cancerNL-OMON44999Stichting NVALT studies40
进行中（未招募）
1 期
Study with BIBF1120 in lung canger patients with an abnormal fibroblast growth factor-1 receptor (NVALT-15 study)on small cell lung cancerMedDRA version: 17.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.1 Level: PT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-004324-11-ESStichting NVALT studies80
尚未招募
不适用
Treatment with BIBF1120 capsules lung carcinoma patients with an abnormal fibroblast growth factor-1 receptor (NVALT15)on-small cell lung cancer (NSCLC).NL-OMON28108ederlandse Vereniging van Artsen voor Longziekten en Tuberculose NVALT (dutch society of pulmonary physicians)80
已完成
1 期
Gefitinib and Radiation Therapy in Treating Patients With Glioblastoma MultiformeAdult Giant Cell GlioblastomaAdult GlioblastomaAdult GliosarcomaNCT00052208National Cancer Institute (NCI)158
已完成
2 期
Fibroblast Growth Factor Regeneration of Tympanic Membrane PerforationsTympanic Membrane PerforationNCT04960384NYU Langone Health52