Status:
COMPLETED
BIBF 1120 as Second Line Treatment for Small Cell Lung Cancer
Lead Sponsor:
Ji-youn Han
Collaborating Sponsors:
National Cancer Center, Korea
Conditions:
Small Cell Lung Cancer
Small Cell Lung Cancer Recurrent
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Although chemotherapy is the primary treatment option for small cell lung cancer (SCLC), longterm survival is rare. SCLC is initially chemosensitive, but rapidly relapses in a chemoresistant form with...
Detailed Description
Chemotherapy is the primary treatment option for patients with small cell lung cancer (SCLC), leading to a 5-year survival of about 20% in limited disease (LD), and less than 5% in extensive disease (...
Eligibility Criteria
Inclusion
- Histologically confirmed SCLC
- Progression during or after prior first line chemotherapy.
- At least one target tumor lesion RECIST 1.1)
- Life expectancy of at least three months
- ECOG PS 0-2
- Written informed consent
Exclusion
- Previous therapy with other VGFR inhibitors (other than bevacizumab)
- Persistence of clinically relevant therapy related toxicities from previous chemotherapy and/or radiotherapy
- Chemo-, hormone-, immunotherapy with monoclonal antibodies, treatment with tyrosine kinase inhibitors, or radiotherapy (except for brain and extremities) within the past 3 weeks prior to treatment with the trial drug i.e., the minimum time elapsed since the last anticancer therapy and the first administration of BIBF 1120 must be 3 weeks
- Treatment with other investigational drugs or treatment in another clinical trial within the past three weeks before start of therapy or concomitantly with this trial
- Concomitant yellow fever vaccination
- Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease. Patients should have completed surgery or radiation therapy for existing brain metastases, should not have documented increase in size over the previous 3 months and should be asymptomatic off steroids
- 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 (more than one teaspoon of fresh blood per day)
- Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except for chronic low-dose therapy with acetylsalicylic acid ≤325mg per day)
- 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 (i.e., hypertension not controlled by medical therapy, unstable angina, history of myocardial infarction within the past 12 months, congestive heart failure \> NYHA II, serious cardiac arrhythmia, pericardial effusion)
- Calculated creatinine clearance by Cockcroft Gault \<45ml/min
- Proteinuria CTCAE grade 2 or greater
- Total bilirubin above the upper limit of normal
- ALT and/or AST \> 2.5 x upper limit of normal in the presence of live metastasis or ALT and/or AST \>1.5 x upper limit of normal in patients without liver metastasis.
- Prothrombin time and/or partial thromboplastin time greater than 50% deviation from normal limits
- Platelets \<100000 platelets/μL (=mm3)
- Significant weight loss (\> 10 %) within the past 6 weeks prior to treatment in the present trial
- Current peripheral neuropathy ≥ CTCAE(version4.0) Grade 2 except due to trauma
- Pre-existing ascites and/or clinically significant pleural effusion
- Major injuries and/or surgery within the past ten days prior to randomization with incomplete wound healing
- Serious infections requiring systemic antibiotic (e.g. antiviral, antimicrobial, antifungal) therapy
- Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
- Active or chronic hepatitis C and/or B infection
- Known human immunodeficiency virus (HIV) seropositivity
- serious illness or concomitant non-oncological disease or
- Pregnancy or breast feeding
- Active alcohol or drug abuse
- Other malignancy within the past three years
- Hypersensitivity to BIBF 1120 and/or the excipients of the trial drugs
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01441297
Start Date
December 1 2011
End Date
March 31 2016
Last Update
August 25 2017
Active Locations (1)
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1
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea, 410-769