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Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non Small Cell Lung Cancer.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00160043
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : December 16, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 12, 2005
Last Update Posted Date December 16, 2014
Study Start Date  ICMJE March 2005
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2008)
Tumor response rate (complete or partial response according to RECIST). [ Time Frame: At baseline and every 8 weeks afterwards ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
Tumor response rate (complete or partial response according to RECIST).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2008)
Time to disease progression. [ Time Frame: At baseline and every 8 weeks afterwards ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
Time to disease progression.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non Small Cell Lung Cancer.
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: SH T00268C
    1250 mg experimental drug od
  • Drug: PTK787/ ZK 222584
    1250 mg experimental drug bid (500mg + 750mg)
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: SH T00268C
  • Experimental: Arm 2
    Intervention: Drug: PTK787/ ZK 222584
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2014)
112
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00160043
Other Study ID Numbers  ICMJE 91411
2004-002290-22 ( EudraCT Number )
308801 ( Other Identifier: Company internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP