check_circleStudy Completed

Non Small Cell Lung Cancer

Bayer Identifier:

91411

ClinicalTrials.gov Identifier:

NCT00160043

EudraCT Number:

2004-002290-22

EU CT Number:

Not Available
Safety and efficacy study of a new chemotherapy agent to treat non small cell lung cancer.

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
112
Trial Dates
March 2005 - November 2008
Phase
Phase 2
Could I Receive a placebo
No
Products
VEGF-Tyrosine Kinase Inhibitor (BAY86-5127)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Universitätsklinikum EssenEssen, 45122, Germany
Completed
Universitätsmedizin der Georg-August-Universität GöttingenGöttingen, 37075, Germany
Completed
Institut Gustave RoussyVillejuif, 94805, France
Completed
Hospital TenonParis, 75970, France
Completed
Hospital de la Pitie Salpetriere Service Oncologie MedicaleParis, 75651, France
Completed
Johannes-Gutenberg-Universität MainzMainz, 55131, Germany

Primary Outcome

  • Tumor response rate (complete or partial response according to RECIST).
    date_rangeTime Frame:
    At baseline and every 8 weeks afterwards
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    Safety Issue:
    yes

Secondary Outcome

  • Time to disease progression.
    date_rangeTime Frame:
    At baseline and every 8 weeks afterwards
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
2

Additional Information

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