|- candidate number||17700|
|- NTR Number||NTR4588|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-mei-2014|
|- Secondary IDs||NL46603.042.13 METC UMCG 2014/113|
|- Public Title||Treatment with BIBF1120 capsules lung carcinoma patients with an abnormal fibroblast growth factor-1 receptor (NVALT15)|
|- Scientific Title||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 (NVALT15)|
|- hypothesis||Second line treatment with BIBF1120 will have a positive effect on progression free survival (PFS) of lung cancer patients with an FGFR1 gene amplified in their tumor cells.|
|- Healt Condition(s) or Problem(s) studied||Non small cell lung cancer (NSCLC)|
|- Inclusion criteria||• Stage IIIB or IV after failure of first line treatment or recurrent NSCLC haboring a positive FISH for FGFR1 amplification. |
• Age ≥ 18 years.
• Measurable disease
• ECOG Performance Status of 0 – 1.
• Life expectancy > 3 months.
|- Exclusion criteria||• Other investigational drugs or treatment in another clinical trial within the past 4 weeks.|
• Chemo-, hormone-, immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks.
• Radiotherapy on the target lesions within the last 4 weeks.
• Previous therapy with other VEGFR inhibitors or VEGF ligand inhibitors for treatment of NSCLC.
• Symptomatic brain metastases or leptomeningeal disease.
• Radiographic evidence of cavitation or necrotic tumors.
• Centrally located tumors with radiographic evidence of local invasion of major blood vessels.
• History of clinically significant haemoptysis within the past 3 months.
• Known inherited predisposition to bleeding or thrombosis.
• Pre-existing ascites and/or clinically significant pleural effusion.
• 21. Patients who are sexually active and unwilling to use a medically acceptable method of contraception..
• Pregnancy or lactation.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-jun-2014|
|- planned closingdate||1-jun-2017|
|- Target number of participants||80|
|- Interventions||Treatment with BIBF1120.|
|- Primary outcome||Progression free survival.|
|- Secondary outcome||Response rate, duration of response, overall survival, safety and tolerability.|
|- Trial web site||www.nvalt.nl|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. H.J.M. Groen|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. H.J.M. Groen|
|- Sponsor/Initiator ||Nederlandse Vereniging van Artsen voor Longziekten en Tuberculose (NVALT)|
(Source(s) of Monetary or Material Support)
|Nederlandse Vereniging voor Artsen voor Longziekten en Tuberculose (NVALT)|
|- Brief summary||BIBF1120 is a potent oral inhibitor of FGFR 1 and 3. This is a multicenter two-country non-comparative phase II study in 76 patients with stage IIIB or IV after failure of first line treatment or recurrent squamous and large cell lung cancer with FGFR1 amplification. Age 18 years and above. Treatment with BIBF1120. We hypothesize that these patients will show an improved progression free survival to BIBF1120.|
|- Main changes (audit trail)|
|- RECORD||9-mei-2014 - 4-jun-2014|