drugset / Trial / NCT00094861
Study to Evaluate Palifermin in the Reduction of Dysphagia in Patients With Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to determine if palifermin will reduce the incidence of dysphagia in patients receiving concurrent chemoradiotherapy followed by consolidation chemotherapy for treatment of unresectable stage III Non-Small Cell Lung Cancer (NSCLC).
Timeline
- Start
- 2005-01
- Primary completion
- 2007-12
- Completion
- 2014-01
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Placebo vs Palifermin; p = 0.3550; Chi-Square Statistic 0.8553 NCT00094861 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Palifermin | Protein / enzyme biologic | 180 ug/kg | Intravenous |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Paclitaxel | Small molecule | 225 mg/m2 | Intravenous |