Small Cell Lung Cancer Clinical Trial
Official title:
A Phase II Study of BIBF1120 in Recurrent and Platinum-Sensitive Small Cell Lung Cancer (SCLC)
This study is being done to evaluate the good and bad effects of BIBF1120 in recurrent,
platinum-sensitive small cell lung cancer patients and to see if BIBF1120 may or may not be
more effective and better tolerated than standard therapy.
The purpose of this study is to:
- Find out the proportion of patients with their small small cell lung cancer controlled
for at least 90 days after treatment with BIBF1120
- Compare the response rate, survival and side effects of BIBF1120 in recurrent,
platinum-sensitive small cell lung cancer patients
- Identify a group of patients who will benefit the most from BIBF1120 In this study,
patients will receive BIBF1120 at 200 mg twice daily continuously. A cycle will be 21
days. During treatment, the dose of BIBF1120 will be held or reduced to lower doses if
patients do not tolerate it well or if the doctors are concerned about the side effects
of BIBF1120 on individual patients.
This study is being done to evaluate the effects of BIBF1120 in recurrent,
platinum-sensitive small cell lung cancer patients.
Primary Objectives:
- To investigate the efficacy and safety of a novel VEGFR-2 and FGFR-1 targeting agent,
BIBF1120, in previously treated, platinum-sensitive small cell lung cancer patients.
Secondary Objectives:
- To correlate response to the apoptotic biomarkers, Bcl-XL/Bcl-2 and FDGR-1
amplification.
- To correlate response with baseline FLT-PET SUV uptake and change in FLT-PET SUV
uptake.
All eligible patients will be treated with 200 mg bid of BIBF1120 daily and 21 days will be
considered as one cycle
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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