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Clinical Trials/NCT00160043
NCT00160043
Completed
Phase 2

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)

Bayer0 sites112 target enrollmentMarch 2005
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ConditionsNon Small Cell Lung Cancer
InterventionsSH T00268CPTK787/ ZK 222584
DrugsSH T00268CPTK787/ ZK 222584

Overview

Phase
Phase 2
Intervention
SH T00268C
Conditions
Non Small Cell Lung Cancer
Sponsor
Bayer
Enrollment
112
Primary Endpoint
Tumor response rate (complete or partial response according to RECIST).
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2005
End Date
November 2008
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Bayer
Responsible Party
Sponsor

Eligibility 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

Arms & Interventions

Arm 1

Intervention: SH T00268C

Arm 2

Intervention: PTK787/ ZK 222584

Outcomes

Primary Outcomes

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

Time Frame: At baseline and every 8 weeks afterwards

Secondary Outcomes

  • Time to disease progression.(At baseline and every 8 weeks afterwards)

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