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Clinical Trials/EUCTR2005-000586-19-DE
EUCTR2005-000586-19-DEActive, not recruitingNot 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 sitesStarted: December 5, 2005Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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
  • •7. Adequate recovery (excluding alopecia) from previous surgery, radiation, and
  • •chemotherapy
  • •8. Adequate function of major organs and systems
  • •Nervous system:
  • •- No Grade 2 or greater peripheral neuropathy
  • •Hematopoietic:
  • •- Hemoglobin: = 10 g/dL
  • •- WBC: = 3,000/mm3
  • •- Absolute neutrophil count: = 1,500/mm3
  • •- Platelet count: = 100,000/mm3
  • •- Total bilirubin: normal
  • •- AST/ALT: = 2.5 times the upper limit of normal
  • •- Creatinine: = 2 mg/dL
  • •Cardiovascular:
  • •- No symptomatic congestive heart failure
  • •- No unstable angina pectoris
  • •- No arrhythmia needing continuous treatment
  • •No other uncontrolled concurrent illness
  • •9. Survival expectation = 3 months
  • •10. Negative pregnancy test at enrollment (females of childbearing potential only)
  • •11. Agreement to use highly effective contraception methods (intra-uterine
  • •contraceptive device IUCD, condoms, oral contraceptives, or other adequate
  • •barrier contraception) in females of child-bearing potential
  • •12. Written informed consent
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

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
  • •9. History of any other primary malignancy with the exceptions of non- melanoma skin cancer and carcinoma in situ of the cervix

Investigators

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