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Completed

NCT Number: NCT00160043

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

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.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SH T00268C

Drug

1250 mg experimental drug od

PTK787/ ZK 222584

Drug

1250 mg experimental drug bid (500mg + 750mg)

Primary outcomes

  1. Tumor response rate (complete or partial response according to RECIST).

    Time frame: At baseline and every 8 weeks afterwards

Secondary outcomes

  1. Time to disease progression.

    Time frame: At baseline and every 8 weeks afterwards

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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)

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Sep 12, 2005
Registry last updated
Dec 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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