Woman and Man
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Extract
To evaluate the pharmacokinetic profile and biological activity on buccal mucosae of palifermin administered at the dose of 120 μg/kg IV in a cohort of at least 16 (3 palifermin : 1 placebo) locally advanced HNC subjects receiving RT with concurrent CT as adjuvant treatment for their disease (post-operative setting). To evaluate the safety and tolerability of palifermin when administered at the dose of 120 μg/kg weekly for up to 8 consecutive weeks to patients with locally advanced HNC receiving RT with concurrent CT as adjuvant treatment for their disease (post-operative setting).
Inclusion criteria
- Oral mucositis