Pharmacokinetic Study of Palifermin in Subjects Receiving Radiation Therapy and Chemotherapy Followed by Blood Stem Cell Support
An Open-label Study of the Pharmacokinetics (PK) of Recombinant Human Keratinocyte Growth Factor (Palifermin; rHuKGF) in Subjects With Hematologic Malignancies Undergoing Total Body Irradiation and High-dose Chemotherapy Followed by Peripheral Blood Progenitor Cell (PBPC) Transplantation
1 other identifier
interventional
25
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 leukemia
Started Dec 2001
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2001
CompletedFirst Submitted
Initial submission to the registry
October 6, 2003
CompletedFirst Posted
Study publicly available on registry
October 8, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedOctober 24, 2014
October 1, 2014
3.2 years
October 6, 2003
October 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To characterize the PK profile of 3 daily intravenous (IV) doses of rHuKGF before total body irradiation (TBI) / high-dose chemotherapy conditioning treatment and after PBPC transplantation
Secondary Outcomes (2)
To assess the safety and tolerability of rHuKGF in subjects with hematologic malignancies undergoing TBI and high-dose chemotherapy followed by PBPC transplantation.
To assess oral mucositis in subjects receiving rHuKGF.
Study Arms (2)
Palifermin 6 x 60 μg/kg/day
EXPERIMENTALThe first 3 consecutive daily doses were administered before the initiation of conditioning therapy (study days -11, -10, and -9); 3 additional consecutive daily doses were administered after administration of radiotherapy, chemotherapy and PBPC transplantation (study days 0, 1, and 2).
Palifermin 2 x 180 μg/kg/day
EXPERIMENTALThe first dose was administered on study day -11, 3 days before the initiation of conditioning therapy, and the second dose was given on day 0 after administration of radiotherapy, chemotherapy and the PBPC infusion
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Swedish Orphan Biovitrumlead
- Amgencollaborator
Related Publications (1)
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.
PMID: 17896890RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2003
First Posted
October 8, 2003
Study Start
December 1, 2001
Primary Completion
March 1, 2005
Study Completion
March 1, 2005
Last Updated
October 24, 2014
Record last verified: 2014-10