Primary: To assess PFS of lung cancer patients with an FGFR1 gene amplified in their tumor cells upon treatment with BIBF1120.Secondary: To assess response rate, duration of response, overall survival and safety.
ID
Source
Brief title
Condition
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Progression free survival.
Secondary outcome
Response rate, duration of response, overall survival and safety
Background summary
Array comparative genomic hybridization showed amplifications of the 8p11-p12
region including the FGFR(fibroblast growth factor receptor)1 locus in 40% of
patients with squamous cell lung carcinoma. With FISH technique FGFR1
amplifications were detected in more than 20% of cases. This focal
amplification associates with therapeutically tractable FGFR1 dependency in
predominantly squamous cell lung cancer. BIBF1120 is a potent oral inhibitor of
FGFR 1 and 3. We hypothesized that patients with an amplified FGFR1 gene in
their tumor cells will show an improved progression free survival (PFS) to
BIBF1120.
Study objective
Primary: To assess PFS of lung cancer patients with an FGFR1 gene amplified in
their tumor cells upon treatment with BIBF1120.
Secondary: To assess response rate, duration of response, overall survival and
safety.
Study design
Multicenter phase II study.
Treatment with oral BIBF1120 200 mg bid.
Treatment duration: till disease progression.
Approx. 76 patients.
Intervention
Treatment with BIBF1120.
Study burden and risks
Risk: Adverse events of study treatment.
Burden: In line with standard treatment with the exception of:
* Tumor tissue examination for FGFR1 status (archived tumor tissue; if not
available: fresh material) during screening.
* Blood draw (20 ml) for biomarkers.
Luijbenstraat 15
"s-Hertogenbosch 5211 BR
NL
Luijbenstraat 15
"s-Hertogenbosch 5211 BR
NL
Listed location countries
Age
Inclusion criteria
* Stage IIIB or IV 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. i
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-004324-11-NL |
| Other | Nederlands Trial Register, registratienummer 4588 |
| CCMO | NL46603.042.14 |
| OMON | NL-OMON28108 |