drugset / Trial / NCT00323518
A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis
RandomizedParallel-groupQuadruple-blindPrevention
Summary
CG53135-05 (velafermin), a recombinant human fibroblast growth factor-20 (rhFGF-20) protein, is under investigation for the prevention of oral mucositis. Oral mucositis is a commonly occurring side effect of high-dose chemotherapy in patients undergoing autologous hematopoietic stem cell transplant. The objective of this Phase II trial is to confirm the safety and efficacy of CG53135-05 (velafermin) when administered as a single dose to patients at risk for developing oral mucositis.
Timeline
- Start
- 2006-05
- Primary completion
- 2008-08
- Completion
- 2008-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | velafermin | Protein / enzyme biologic | 10 ug/kg | Intravenous |
| Subject | velafermin | Protein / enzyme biologic | 30 ug/kg | Intravenous |
| Subject | velafermin | Protein / enzyme biologic | 60 ug/kg | Intravenous |