Palifermin

Generic Name
Palifermin
Brand Names
Kepivance
Drug Type
Biotech
Chemical Formula
-
CAS Number
162394-19-6
Unique Ingredient Identifier
QMS40680K6
Background

Palifermin is a recombinant human keratinocyte growth factor (KGF). It is 140 residues long, and is produced using E. coli.

Palifermin was granted FDA approval on 15 December 2004.

Indication

For treatment of oral mucositis associated with chemotherapy and radiation therapy.

Associated Conditions
Oral Mucositis
Associated Therapies
-

Palifermin After Haploidentical PBSCT

First Posted Date
2007-12-11
Last Posted Date
2012-05-10
Lead Sponsor
European Society for Blood and Marrow Transplantation
Registration Number
NCT00570999
Locations
🇩🇪

Dr Ruth Seggewiss, Würzburg, Germany

A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Subjects With Acute Leukemias Undergoing HSCT

First Posted Date
2007-04-16
Last Posted Date
2014-12-05
Lead Sponsor
Swedish Orphan Biovitrum
Target Recruit Count
27
Registration Number
NCT00460421
Locations
🇺🇸

University of Texas, Dallas, Texas, United States

🇺🇸

Arizona Cancer Center, Tucson, Arizona, United States

🇺🇸

Loma Linda University, Loma Linda, California, United States

and more 4 locations

Gemcitabine Plus Busulfan, Melphalan and Hematopoietic Cell Transplant for Advanced Lymphoid Malignancies

First Posted Date
2006-12-13
Last Posted Date
2016-06-03
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
145
Registration Number
NCT00410982
Locations
🇺🇸

UT MD Anderson Cancer Center, Houston, Texas, United States

A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Stage 2B or 3 Locally Advanced, Colon Cancer

Phase 2
Completed
Conditions
Interventions
First Posted Date
2006-10-29
Last Posted Date
2014-07-15
Lead Sponsor
Amgen
Target Recruit Count
100
Registration Number
NCT00393822

Effectiveness of Palifermin in Increasing CD4 Counts in Treatment-Experienced HIV Infected Adults

Phase 2
Completed
Conditions
Interventions
First Posted Date
2006-09-15
Last Posted Date
2021-11-04
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
99
Registration Number
NCT00376935
Locations
🇺🇸

Hosp. of the Univ. of Pennsylvania CRS, Philadelphia, Pennsylvania, United States

🇺🇸

IHV Baltimore Treatment CRS, Baltimore, Maryland, United States

🇺🇸

Bmc Actg Crs, Boston, Massachusetts, United States

and more 19 locations

Palifermin DDI (Drug Drug Interaction)

Phase 1
Completed
Conditions
Interventions
First Posted Date
2006-08-08
Last Posted Date
2014-11-06
Lead Sponsor
Swedish Orphan Biovitrum
Target Recruit Count
45
Registration Number
NCT00361348

Evaluate PKs and Efficacy Assessment of Palifermin in Patients With Sarcoma

First Posted Date
2005-12-20
Last Posted Date
2012-05-16
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
49
Registration Number
NCT00267046
Locations
🇺🇸

U.T.M.D. Anderson Cancer Center, Houston, Texas, United States

A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer

Phase 3
Completed
Conditions
Interventions
First Posted Date
2005-08-19
Last Posted Date
2016-12-16
Lead Sponsor
Amgen
Target Recruit Count
241
Registration Number
NCT00131638
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