A study to evaluate the effects of palifermin in reducing mouth ulceration in subjects with locally advanced head and neck cancer
- Registry ID
- EUCTR2004-002016-28
- Source registry
- EUCTR
- Status
- Completed
- Phase
- PHASE3
- Sponsor
- Amgen
- Start date
- 2005-01-04
- Completion date
- 2007-10-17
- Last update
- 2026-08-16
Conditions
- Oral mucositis
- Mucositis associated with adjuvant radiation and chemotherapy in postoperative HNC setting
Summary
To evaluate the efficacy of palifermin administered at the dose of 120 mcg/kg IV in weekly doses (minimum of 7 weekly doses, until RT is complete) in reducing the incidence of severe [World Health Organization Grade 3 or 4] oral mucositis (OM) in locally advanced HNC subjects receiving RT with concurrent CT as adjuvant treatment for their disease (post-operative setting).
Locations
- , , Italy
- , , UK
- , , Germany
- , , Spain
- , , Austria
View on source registry