Carcinoma, Non Small Cell Lung
Conditions
Keywords
Stage IIIB or stage IV non-small-cell lung cancer.
Brief summary
Phase 2 study to investigate the efficacy and tolerability of epothilone ZK 219477 in patients with stage IIIb or stage IV non-small-cell lung cancer.
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.
Interventions
16 mg/m2, 3-hour infusion, every 3 weeks
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Non-small-cell lung cancer * Only one previous chemotherapy with a platinum-containing drug * Use of highly effective birth control methods in females of child-bearing potential
Exclusion criteria
* No more than 1 previous chemotherapy for advanced disease * Previous participation in another trial within the last 4 weeks * Breast feeding * Active infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy variable is defined as Proportion of patients with either CR or PR as 'best overall response'. Tumor assessment is performed according to RECIST criteria. | Tumor evaluation (MRI or scan) every 2 cycles until disease progression. |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives : investigate the safety and tolerability of ZK 219477 | Continuously |
Countries
Germany
Outcome results
None listed