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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

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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: SH T00268C Drug: PTK787/ ZK 222584 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2005
Actual Primary Completion Date : August 2007
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1 Drug: SH T00268C
1250 mg experimental drug od

Experimental: Arm 2 Drug: PTK787/ ZK 222584
1250 mg experimental drug bid (500mg + 750mg)




Primary Outcome Measures :
  1. Tumor response rate (complete or partial response according to RECIST). [ Time Frame: At baseline and every 8 weeks afterwards ]

Secondary Outcome Measures :
  1. Time to disease progression. [ Time Frame: At baseline and every 8 weeks afterwards ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00160043


Locations
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France
Paris, France, 75651
Paris, France, 75970
Villejuif, France, 94805
Germany
Göttingen, Niedersachsen, Germany, 37075
Essen, Nordrhein-Westfalen, Germany, 45122
Mainz, Rheinland-Pfalz, Germany, 55131
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
Publications of Results:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00160043    
Other Study ID Numbers: 91411
2004-002290-22 ( EudraCT Number )
308801 ( Other Identifier: Company internal )
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: December 16, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Vatalanib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action