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

December 14, 2014 updated by: Bayer

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

112

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75970
      • Paris, France, 75651
      • Villejuif, France, 94805
  • Germany
    • Niedersachsen
      • Göttingen, Niedersachsen, Germany, 37075
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45122
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor response rate (complete or partial response according to RECIST).
Time Frame: At baseline and every 8 weeks afterwards
At baseline and every 8 weeks afterwards

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to disease progression.
Time Frame: At baseline and every 8 weeks afterwards
At baseline and every 8 weeks afterwards

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

December 16, 2014

Last Update Submitted That Met QC Criteria

December 14, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91411
  • 2004-002290-22 (EudraCT Number)
  • 308801 (Other Identifier: Company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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