Pharmacokinetic Study of Palifermin in Subjects Receiving Radiation Therapy and Chemotherapy Followed by Blood Stem Cell Support

Phase 1 Completed 25 enrolled Swedish Orphan Biovitrum Amgen · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Open label palifermin will be administered to subjects who are at a risk of developing mucositis after radiotherapy and chemotherapy followed by blood stem cell support. The amount of palifermin in the blood following administration will be evaluated. The safety of palifermin administration and its effect on reducing mucositis will also be evaluated.

Timeline

Start: 2001-12
Primary completion: 2005-03
Completion: 2005-03

Publications

Results Zia-Amirhosseini P, Hurd DD, Salfi M, Cheah TC, Aycock J, Cesano A. Pharmacokinetics of palifermin administered as the standard dose and as a collapsed dose in patients with hematologic malignancies. Pharmacotherapy. 2007 Oct;27(10):1353-60. doi: 10.1592/phco.27.10.1353.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Palifermin	Protein / enzyme biologic	60 ug/kg	Intravenous
Subject	Palifermin	Protein / enzyme biologic	180 ug/kg	Intravenous

Pharmacokinetic Study of Palifermin in Subjects Receiving Radiation Therapy and Chemotherapy Followed by Blood Stem Cell Support

Summary

Timeline

Publications

Drugs

Indications