A Study to Evaluate the Good and Bad Effects of BIBF1120 in Small Cell Lung Cancer Patients Who Have Previously Benefited From First-line Platinum-based Chemotherapy

Exclusion Criteria

• •Symptomatic, untreated brain metastasis. Patients with asymptomatic brain metastasis defined as those with no CNS symptoms, no concurrent significant edema on CT or MRI of the brain and no concurrent corticosteroid therapy will be eligible. Those with leptomeningeal disease will NEVER be eligible due to overall poor prognosis. Patients who have treated brain metastasis without concurrent corticosteroid and anti-convulsant therapy and without progression on CT or MRI scan of the brain for at least 60 days will be eligible
• •Symptoms of congestive heart failure, myocardial infarction or angina within 6 months.
• •Previous allergy to VEGR or FGF tyrosine kinase inhibitor.
• •Current therapeutic coumadin treatment.
• •History of hemoptysis of more than 5 mL per episode or more than 10 mL/week in total within the past 3 months.
• •History of bleeding disorder.
• •Surgery, hormonal therapy, chemotherapy, radiation therapy or other investigational agents within 28 days of enrollment, with the exception of low dose palliative RT (20 Gy or less involving \< 10% bone marrow).
• •History of recent gastrointestinal bleeding, obstruction or perforation of malabsorption syndrome.
• •History of QT c \> 480 ms on ECG or hsitory of cardiac arrhythmia or treatment with anti-arrhythmic except for atrial fibrillation or any history of second- or third-degree heart block.
• •Diagnosis of HIV infection or AIDS.
• •Diagnosis of interstitial lung disease.
• •Radiotherapy (except extremities) within the past 2 months prior to baseline imaging.
• •Persistence of clinically relevant therapy-related toxicity from previous chemotherapy and/or radiotherapy.
• •Leptomeningeal disease.
• •Radiographic evidence of cavitary or necrotic tumors.
• •Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels. As small cell lung cancer is often presented as a mediastinal mass, compression of mediastinal blood vessels will be allowed.
• •Therapeutic anticoagulation (except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous device) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid \< 325 mg per day).
• •Major injuries within the past 10 days prior to start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period.
• •History of clinically significant haemorrhagic or thromboembolic event in the past 6 months.
• •Proteinuria CTCAE grade 2 or greater.
• •Other malignancies within the past 5 years other than basal cell skin cancer or carcinoma in situ of the cervix.
• •Active serious infections, in particular if requiring systemic antibiotic or antimicrobial therapy.
• •Active or chronic hepatitis C and/or B infection.
• •Active alcohol or drug abuse.
• •Significant weight loss (\> 10% of body weight) within past 6 months prior to inclusion into the trial