BIBF 1120 as Second Line Treatment for Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2016-03-31
• Target enrollment: 0
• Participant gender: All

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 an overall survival of <5%. Consequently, novel therapies are urgently required and will likely arise from an improved understanding of the disease biology. Some preclinical studies have showed that fibroblast growth factor-2 induces proliferation and

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ji-youn Han
• Collaborator: National Cancer Center, Korea
• Treatments: Nintedanib

Criteria

Inclusion Criteria:

1. Histologically confirmed SCLC

2. Progression during or after prior first line chemotherapy.

3. At least one target tumor lesion RECIST 1.1)

4. Life expectancy of at least three months

5. ECOG PS 0-2

6. Written informed consent

Exclusion Criteria:

1. Previous therapy with other VGFR inhibitors (other than bevacizumab)

2. Persistence of clinically relevant therapy related toxicities from previous chemotherapy and/or radiotherapy

3. 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

4. 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

5. Concomitant yellow fever vaccination

6. 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

7. Radiographic evidence of cavitary 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 (more than one teaspoon of fresh blood per day)

10. 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)

11. History of major thrombotic or clinically relevant major bleeding event in the past 6 months

12. Known inherited predisposition to bleeding or thrombosis

13. 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)

14. Calculated creatinine clearance by Cockcroft Gault <45ml/min

15. Proteinuria CTCAE grade 2 or greater

16. Total bilirubin above the upper limit of normal

17. 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.

18. Prothrombin time and/or partial thromboplastin time greater than 50% deviation from normal limits

19. Platelets <100000 platelets/μL (=mm3)

20. Significant weight loss (> 10 %) within the past 6 weeks prior to treatment in the present trial

21. Current peripheral neuropathy ≥ CTCAE(version4.0) Grade 2 except due to trauma

22. Pre-existing ascites and/or clinically significant pleural effusion

23. Major injuries and/or surgery within the past ten days prior to randomization with incomplete wound healing

24. Serious infections requiring systemic antibiotic (e.g. antiviral, antimicrobial, antifungal) therapy

25. Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug

26. Active or chronic hepatitis C and/or B infection

27. Known human immunodeficiency virus (HIV) seropositivity

28. serious illness or concomitant non-oncological disease or

29. Pregnancy or breast feeding

30. Active alcohol or drug abuse

31. Other malignancy within the past three years

32. Hypersensitivity to BIBF 1120 and/or the excipients of the trial drugs