Status:
TERMINATED
BIBF 1120 in Combination With Pemetrexed in Advanced Non Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
20-74 years
Phase:
PHASE1
Brief Summary
The objectives of this trial are to estimate the following in Japanese patients with advanced NSCLC of stage IIIB/IV or with recurrence after failure of first-line chemotherapy. Phase I part The obje...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male or female patients of age \>=20 and \<=74 years at informed consent
- Histologically or cytologically confirmed, Non Small Cell Lung Cancer (NSCLC) of stage IIIB or IV or recurrent NSCLC
- Relapse or failure of 1 first-line prior chemotherapy
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Patients who have sufficient baseline organ function over 4 weeks and whose laboratory data meet the following criteria at the enrolment
- Haemoglobin \>=9.0 g/dL
- Absolute neutrophil count (ANC) \>=1500/mm\^3
- Platelet count \>=100 000/mm\^3
- Total bilirubin under the upper limit of normal
- AST/SGOT and/or ALT/GPT \<=1.5 x upper limit of normal (if related to liver metastases \<=2.5 x upper limit of normal also)
- Proteinuria Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or less
- Calculated creatinine clearance by Cockcroft Gault \>=45 mL/min
- Prothrombin time-international normalized ratio (PT-INR) and/or partial thromboplastin time (PTT) greater than 50% deviation from normal limits
- arterial oxgen pressure (PaO2) \>=60 torr or oxygen saturation by pulse-oximeter SpO2 \>=92%
- Patient has given written informed consent which must be consistent with ICH-GCP and local legislation.
- Exclusion criteria:
- 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)
- 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) .
- Patients who have received radiotherapy within the following period Phase I part: the past 4 weeks prior to treatment with the trial drug (in case of palliative radiotherapy such as for extremities, within the past 2 weeks prior to treatment with the trial drug)
- Previous therapy with other vascular endothelial growth factor receptor (VEGFR) inhibitors or vascular endothelial growth factor (VEGF) ligand inhibitors for treatment of NSCLC
- Previous therapy with BIBF 1120 and/or pemetrexed for treatment of NSCLC and any contraindications for therapy with pemetrexed
- Patients who have active brain metastases
- Leptomeningeal disease
- Patients with distinct or suspected pulmonary fibrosis or interstitial lung disease by the CT findings, or patients with a previous history of pulmonary fibrosis or interstitial lung disease (except irradiation-pneumonitis appearing radiation field with past radiotherapy).
- Radiographic evidence of cavitary or necrotic tumors
- Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels
- History of clinically significant haemoptysis within the past 3 months
- History of major thrombotic or clinically relevant major bleeding event in the past 6 months
- Known inherited predisposition to bleeding or thrombosis
- Significant cardiovascular diseases
- Significant weight loss (\>10%) within the past 6 weeks prior to treatment in the present trial
- Current peripheral neuropathy CTCAE grade 2 or greater except due to trauma
- Pre-existing ascites and/or clinically significant pleural effusion
- Major injuries and/or surgery within the past 4 weeks prior to randomisation with incomplete wound healing
- Clinically serious infections
- Decompensated diabetes mellitus
- Contraindication to high dose steroid therapy
- Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
- Patients who have active or chronic hepatitis C and/or B infection and diagnosis of human immunodeficiency virus (HIV) infection
- 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
- History of serious drug hypersensitivity
- 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
- Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy
- Patients who are sexually active and unwilling to use a medically acceptable method of contraception
- Pregnancy or breast feeding
- Active alcohol or drug abuse
- Patients unable to comply with the protocol
- Other patients judged ineligible for enrolment in the study by the investigator or subinvestigator.
Exclusion
Key Trial Info
Start Date :
October 16 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2015
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00979576
Start Date
October 16 2009
End Date
February 16 2015
Last Update
March 6 2025
Active Locations (3)
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1
1199.28.003 Boehringer Ingelheim Investigational Site
Chiba,Kashiwa, Japan
2
1199.28.002 Boehringer Ingelheim Investigational Site
Miyakojima-ku, Osaka, Japan
3
1199.28.001 Boehringer Ingelheim Investigational Site
Osaka-Sayama, Osaka, Japan