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Clinical Trials/EUCTR2005-000586-19-DE
EUCTR2005-000586-19-DE
Active, not recruiting
Not Applicable

Phase-II study to investigate the efficacy and safety of ZK 219477 as second-line therapy in patients with Stage IIIB or Stage IV non-small-cell lung cancer (NSCLC)

Bayer Schering Pharma AG0 sitesDecember 5, 2005
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Conditionson small cell lung cancer (NSCLC) stage IIIB or stage IV

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
on small cell lung cancer (NSCLC) stage IIIB or stage IV
Sponsor
Bayer Schering Pharma AG
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 5, 2005
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Males or females aged \= 18 years
  • •2\. Histologically or cytologically proven NSCLC, Stage IIIB or Stage IV
  • •3\. At least 1 unidimensionally measurable lesion (suitable for modRECIST
  • •evaluation)
  • •4\. WHO performance status 0 to 1
  • •5\. Treatment failure of one previous platinum\-based chemotherapy regimen
  • •6\. Time period since prior therapy:
  • •\- Prior radiotherapy: \= 3 weeks
  • •\- Prior chemotherapy: \= 3 weeks
  • •\- Prior immunotherapy: \= 3 weeks

Exclusion Criteria

  • •1\. More than one previous chemotherapy regimen for advanced disease
  • •2\. Prior treatment with epothilones
  • •3\. Use of any investigational drug within 4 weeks before start of study treatment
  • •or inadequate recovery from any toxic effects of such therapy
  • •4\. Candidacy for curative resection
  • •5\. Symptomatic brain metastases requiring whole\-brain irradiation
  • •6\. Active infection
  • •7\. Breast feeding
  • •8\. Any condition that in the opinion of the investigator could hamper the
  • •compliance with the study protocol

Outcomes

Primary Outcomes

Not specified

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