Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non Small Cell Lung Cancer.
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)
3 other identifiers
interventional
112
2 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2005
Typical duration for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedDecember 16, 2014
December 1, 2014
2.4 years
September 9, 2005
December 14, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Tumor response rate (complete or partial response according to RECIST).
At baseline and every 8 weeks afterwards
Secondary Outcomes (1)
Time to disease progression.
At baseline and every 8 weeks afterwards
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (6)
Unknown Facility
Paris, 75651, France
Unknown Facility
Paris, 75970, France
Unknown Facility
Villejuif, 94805, France
Unknown Facility
Göttingen, Lower Saxony, 37075, Germany
Unknown Facility
Essen, North Rhine-Westphalia, 45122, Germany
Unknown Facility
Mainz, Rhineland-Palatinate, 55131, Germany
Related Publications (1)
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.
PMID: 21617019RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 12, 2005
Study Start
March 1, 2005
Primary Completion
August 1, 2007
Study Completion
November 1, 2008
Last Updated
December 16, 2014
Record last verified: 2014-12