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.
ID
Bron
Verkorte titel
Aandoening
Non-small cell lung cancer (NSCLC).
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Progression free survival.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Continuously.
Onderzoeksproduct en/of interventie
Treatment with BIBF1120.
Algemeen / deelnemers
Box 30001
H.J.M. Groen
Groningen 9700 RB
The Netherlands
+31 (0)50 3616161
h.j.m.groen@int.umcg.nl
Wetenschappers
Box 30001
H.J.M. Groen
Groningen 9700 RB
The Netherlands
+31 (0)50 3616161
h.j.m.groen@int.umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4374 |
| NTR-old | NTR4588 |
| CCMO | NL46603.042.14 |
| OMON | NL-OMON44999 |