Study with BIBF1120 in lung canger patients with an abnormal fibroblast growth factor-1 receptor (NVALT-15 study)

Phase 1

• Conditions: on small cell lung cancer; MedDRA version: 20.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-004324-11-NL
• Lead Sponsor: Stichting NVALT studies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-12
• Last Update Posted: 5 February 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

1.Stage IIIB or IV or recurrent NSCLC haboring a positive FISH for FGFR1 amplification (> 2 copies). Six unstained slides will be provided to the UMC Groningen to perform the test.
2.Age above 18 years.
3.Measurable tumor lesions (RECIST 1.1)
4.Life expectancy of at least 3 months.
5.Eastern Cooperative Oncology Group (ECOG) score of 0 - 1.
6.Patients who have sufficient baseline organ function and who meet the following criteria at the enrolment:
oAbsolute neutrophil count (ANC) = 1500/mm3;
oPlatelet count = 100 000/mm3;
oTotal bilirubin under the upper limit of normal (=upper limit of the local laboratory facility);
oAST/SGOT and/or ALT/GPT <=1.5 x upper limit of normal (if related to liver metastases <=2.5 x upper limit of normal);
oProteinuria Common Terminology Criteria for Adverse Events (CTCAE version 3.0) grade 1 or less;
oCalculated creatinine clearance by Cockcroft Gault = 45 mL/min;
oProthrombin time-international normalized ratio (PT-INR) and/or partial thromboplastin time (PTT) within normal limits;
oOxygen saturation by pulse-oximeter SpO2 = 92%;
7.Patient has given written informed consent which must be consistent with ICH-GCP and local legislation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

1.Patients who have received treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with this trial or who have not recovered from side effects of such therapy (except for alopecia).
2.Patients who have received chemo-, hormone-, immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks prior to treatment with the trial drug or who have not recovered from side effects of such therapy (except for alopecia).
3.Patients who have received radiotherapy on the target lesions within 4 weeks prior to treatment with the trial drug (in case of palliative radiotherapy such as for extremities, within 2 weeks prior to treatment with the trial drug).
4.Previous therapy with other vascular endothelial growth factor receptor (VEGFR) inhibitors or vascular endothelial growth factor (VEGF) ligand inhibitors for treatment of NSCLC.
5.Previous therapy with BIBF1120.
6.Patients who have symptomatic brain metastases or leptomeningeal disease.
7.Radiographic evidence of cavitation or necrotic tumors.
8.Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels.
9.History of clinically significant haemoptysis within the past 3 months.
10.Known inherited predisposition to bleeding or thrombosis.
11.Current peripheral neuropathy CTCAE version 3.0 grade 2 or greater except due to trauma.
12.Pre-existing ascites and/or clinically significant pleural effusion.
13.Major injuries and/or surgery within the past 4 weeks prior to treatment.
14.Clinically serious infections.
15.Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug.
16.Patients who have active or chronic hepatitis C and/or B infection and diagnosis of human immunodeficiency virus (HIV) infection.
17.Other malignancy other than basal cell skin cancer, carcinoma in situ or intra-mucosal cancer that were judged to be cured by adequate treatment and disease-free interval is more than 5 years.
18.History of serious drug hypersensitivity.
19.Serious illness or concomitant non-oncological disease such as neurologic-, psychiatric-, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation.
20.Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except acetylsalicylic acid up to 100 mg daily).
21.Patients who are sexually active and unwilling to use a medically acceptable method of contraception.
22.Pregnancy or breast feeding.
23.Patients unable to comply with the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Effect of BIBF1120 as a second line treatment on progression-free survival of patients with FGFR1 amplification.;Secondary Objective: Tumor response rate, duration of tumor response, overall survival, safety.;Primary end point(s): Progression free survival;Timepoint(s) of evaluation of this end point: Continuously

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Response, overall survival, safety;Timepoint(s) of evaluation of this end point: Continuously