search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Treatment with BIBF1120 capsules lung carcinoma patients with an abnormal fibroblast growth factor-1 receptor (NVALT15)


- candidate number17700
- NTR NumberNTR4588
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-mei-2014
- Secondary IDsNL46603.042.13 METC UMCG 2014/113
- Public TitleTreatment with BIBF1120 capsules lung carcinoma patients with an abnormal fibroblast growth factor-1 receptor (NVALT15)
- Scientific TitlePhase 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)
- ACRONYMNVALT15
- hypothesisSecond 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) studiedNon 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 receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jun-2014
- planned closingdate1-jun-2017
- Target number of participants80
- InterventionsTreatment with BIBF1120.
- Primary outcomeProgression free survival.
- Secondary outcomeResponse rate, duration of response, overall survival, safety and tolerability.
- TimepointsContinuously.
- Trial web sitewww.nvalt.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. H.J.M. Groen
- CONTACT for SCIENTIFIC QUERIESProf. Dr. H.J.M. Groen
- Sponsor/Initiator Nederlandse Vereniging van Artsen voor Longziekten en Tuberculose (NVALT)
- Funding
(Source(s) of Monetary or Material Support)
Nederlandse Vereniging voor Artsen voor Longziekten en Tuberculose (NVALT)
- PublicationsNone
- Brief summaryBIBF1120 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)
- RECORD9-mei-2014 - 4-jun-2014


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl