Back to resultsSafety and Efficacy Study of a New Chemotherapy Agent to Treat Non Small Cell Lung Cancer.
Primary Purpose
Non Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SH T00268C
PTK787/ ZK 222584
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria: Non small cell lung cancer, Stage IIIB or Stage IV One and only 1 prior platinum-based chemotherapy No other uncontrolled concurrent illness Use of highly effective birth control methods in males or females with reproductive potential Exclusion Criteria: Previous participation in another trial within the last 4 weeks Surgery within 10 days prior to the start of study treatment Brain metastases Confirmed diagnosis of infection with the human immunodeficiency virus (HIV) Current treatment with warfarin sodium (Coumadin) or similar anticoagulation medication Breast feeding
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Tumor response rate (complete or partial response according to RECIST).
Secondary Outcome Measures
Time to disease progression.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00160043
Brief Title
Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non Small Cell Lung Cancer.
Official Title
Phase II Open-label Study to Investigate the Efficacy and Safety of PTK787/ZK 222584 Orally Administered Once Daily or Twice Daily at 1250 mg as Second-line Monotherapy in Patients With Stage IIIB or Stage IV Non-small-cell Lung Cancer (NSCLC)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with non small cell lung cancer who have already received one platinum based chemotherapy.
Detailed Description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SH T00268C
Intervention Description
1250 mg experimental drug od
Intervention Type
Drug
Intervention Name(s)
PTK787/ ZK 222584
Intervention Description
1250 mg experimental drug bid (500mg + 750mg)
Primary Outcome Measure Information:
Title
Tumor response rate (complete or partial response according to RECIST).
Time Frame
At baseline and every 8 weeks afterwards
Secondary Outcome Measure Information:
Title
Time to disease progression.
Time Frame
At baseline and every 8 weeks afterwards
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non small cell lung cancer, Stage IIIB or Stage IV
One and only 1 prior platinum-based chemotherapy
No other uncontrolled concurrent illness
Use of highly effective birth control methods in males or females with reproductive potential
Exclusion Criteria:
Previous participation in another trial within the last 4 weeks
Surgery within 10 days prior to the start of study treatment
Brain metastases
Confirmed diagnosis of infection with the human immunodeficiency virus (HIV)
Current treatment with warfarin sodium (Coumadin) or similar anticoagulation medication
Breast feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Paris
ZIP/Postal Code
75651
Country
France
City
Paris
ZIP/Postal Code
75970
Country
France
City
Villejuif
ZIP/Postal Code
94805
Country
France
City
Göttingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
21617019
Citation
Gauler TC, Besse B, Mauguen A, Meric JB, Gounant V, Fischer B, Overbeck TR, Krissel H, Laurent D, Tiainen M, Commo F, Soria JC, Eberhardt WEE. Phase II trial of PTK787/ZK 222584 (vatalanib) administered orally once-daily or in two divided daily doses as second-line monotherapy in relapsed or progressing patients with stage IIIB/IV non-small-cell lung cancer (NSCLC). Ann Oncol. 2012 Mar;23(3):678-687. doi: 10.1093/annonc/mdr255. Epub 2011 May 26.
Results Reference
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Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non Small Cell Lung Cancer.
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