Evaluate PKs and Efficacy Assessment of Palifermin in Patients With Sarcoma
Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
Participant gender:
Summary
Primary:
1. To evaluate the preliminary efficacy of palifermin in reducing the incidence and
severity of oral mucositis (OM) in patients with sarcoma receiving multicycle
chemotherapy.
2. To evaluate the pharmacokinetics (PK) of palifermin when given pre chemotherapy.
3. To evaluate the safety profile of palifermin when combined with multicycle chemotherapy.
Exploratory:
1. To evaluate the biologic effect of palifermin on oral mucosa.
2. To investigate potential biomarker development by biochemical analysis in blood cells,
serum, and plasma.
3. To investigate the effects of genetic variation in mucositis genes, drug metabolism
genes, and drug target genes on patient response to the treatment regimen.