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
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of BIBF1120 in Recurrent and Platinum-Sensitive Small Cell Lung Cancer (SCLC)|
- Disease control rate [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- Disease response rate [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||July 2014|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
BIBF1120 200 mg twice daily continuously
BIBF1120 is a VEGFR, FGFR and PDGFR inhibitor
Other Name: Nintedanib
This study is being done to evaluate the effects of BIBF1120 in recurrent, platinum-sensitive small cell lung cancer patients.
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02152059
|Contact: Quincy Chu, MD||780-432-8248||Quincy.email@example.com|
|Contact: Romeo Felix, BScN||780-577-8048||Romeo.Felix@albertahealthservices.ca|
|Cross Cancer Institute||Not yet recruiting|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Contact: Quincy Chu, MD 780-432-8248|
|Contact: Romeo Felix, BScN 780-577-8048|
|Principal Investigator:||Quincy Chu, MD||Alberta Health Services|