NCT00323518

A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis

A Phase II Randomized Double Blind Placebo Controlled Trial to Assess Safety and Efficacy of Velafermin for Prevention of Oral Mucositis in Hematologic Cancer Patients Receiving Autologous Stem Cell Transplant

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 390 (actual)
• Sponsor: CuraGen Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oral Mucositis
• Stomatitis

Interventions

Type	Name	Description
DRUG	velafermin	administered intravenously as 100mL single dose over 15 minutes on day 1
DRUG	placebo	administered intravenously as 100mL single dose over 15 minutes on day 1

Timeline

• Start date: 2006-05-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2006-05-09
• Last updated: 2016-04-13

Locations

33 sites across 1 country: United States