drugset / Trial / NCT00109031
Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE)
RandomizedParallel-groupDouble-blindSupportive care
Summary
To evaluate whether palifermin (rHuKGF) administered as a single dose is non-inferior to 3 consecutive doses of palifermin in reducing the incidence of severe oral mucositis (World Health Organization \[WHO\] grade 3 and 4).
Timeline
- Start
- 2005-01
- Primary completion
- 2006-02
- Completion
- 2010-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Palifermin | Protein / enzyme biologic | 60 ug/kg | Intravenous |
| Subject | Palifermin | Protein / enzyme biologic | 180 ug/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 100 mg/kg | — |
| Background | Etoposide | Small molecule | — | Intravenous |