Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-02-05 @ 1:10 AM
Study NCT ID:
NCT02152059
Status:
WITHDRAWN
Last Update Posted:
2016-07-06
First Post:
2014-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
AHS Cancer Control Alberta
Organization:
Study Overview
Official Title:
A Phase II Study of BIBF1120 in Recurrent and Platinum-Sensitive Small Cell Lung Cancer (SCLC)
Status:
WITHDRAWN
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
contract issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: