No registrations found.
ID
Source
Brief title
Health condition
Non-small cell lung cancer (NSCLC).
Sponsors and support
Intervention
Outcome measures
Primary outcome
Progression free survival.
Secondary outcome
Response rate, duration of response, overall survival, safety and tolerability.
Background 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.
Study objective
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.
Study design
Continuously.
Intervention
Treatment with BIBF1120.
Box 30001
H.J.M. Groen
Groningen 9700 RB
The Netherlands
+31 (0)50 3616161
h.j.m.groen@int.umcg.nl
Box 30001
H.J.M. Groen
Groningen 9700 RB
The Netherlands
+31 (0)50 3616161
h.j.m.groen@int.umcg.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4374 |
| NTR-old | NTR4588 |
| CCMO | NL46603.042.14 |
| OMON | NL-OMON44999 |