Palifermin
- Generic Name
- Palifermin
- Brand Names
- Kepivance
- Drug Type
- Biotech
- 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
Standard Chemotherapy with or Without Nelarabine or Rituximab in Treating Patients with Newly Diagnosed Acute Lymphoblastic Leukemia
- Conditions
- LeukemiaOral ComplicationsMucositis
- Interventions
- Procedure: allogeneic hematopoietic stem cell transplantationRadiation: total-body irradiation
- First Posted Date
- 2010-03-12
- Last Posted Date
- 2025-03-30
- Lead Sponsor
- University College, London
- Target Recruit Count
- 1033
- Registration Number
- NCT01085617
Allogeneic Stem Cell Transplantation (ALLOSCT) in Recessive Dystrophic Epidermolysis Bullosa (RDEB)
- Conditions
- Epidermolysis Bullosa
- Interventions
- First Posted Date
- 2009-04-15
- Last Posted Date
- 2021-08-17
- Lead Sponsor
- Columbia University
- Target Recruit Count
- 3
- Registration Number
- NCT00881556
- Locations
- 🇺🇸
The Children's Hospital, Aurora, Colorado, United States
🇺🇸Morgan Stanley Children's Hospital of NYP, New York, New York, United States
🇺🇸Children's Memorial Hospital, Chicago, Illinois, United States
Palifermin in Preventing Oral Mucositis Caused by Chemotherapy and/or Radiation Therapy in Young Patients Undergoing Stem Cell Transplant
- Conditions
- Gastrointestinal MucositisMalignant Neoplasm
- Interventions
- Other: Placebo
- First Posted Date
- 2008-08-06
- Last Posted Date
- 2018-08-07
- Lead Sponsor
- Children's Oncology Group
- Registration Number
- NCT00728585
Dose Escalation Study Of Palifermin in Pediatric Research Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
- Conditions
- Oral MucositisHematopoietic Stem Cell Transplantation
- Interventions
- First Posted Date
- 2008-06-19
- Last Posted Date
- 2012-03-23
- Lead Sponsor
- St. Jude Children's Research Hospital
- Target Recruit Count
- 19
- Registration Number
- NCT00701688
- Locations
- 🇺🇸
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
A Study of Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy and Concurrent Chemotherapy
- Conditions
- MucositisHead and Neck Cancer
- Interventions
- First Posted Date
- 2008-02-29
- Last Posted Date
- 2017-06-21
- Lead Sponsor
- Swedish Orphan Biovitrum
- Target Recruit Count
- 5
- Registration Number
- NCT00626639
Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies
- Conditions
- Acute Myeloid LeukemiaAcute Lymphoblastic LeukemiaMyelodysplasiaChronic Myeloid Leukemia
- Interventions
- Radiation: Total Body IrradiationBiological: Rabbit ATG
- First Posted Date
- 2008-01-15
- Last Posted Date
- 2018-04-10
- Lead Sponsor
- Sherif S. Farag
- Target Recruit Count
- 9
- Registration Number
- NCT00593554
- Locations
- 🇺🇸
Indiana University Cancer Center, Indianapolis, Indiana, United States
Palifermin After Haploidentical PBSCT
- Conditions
- Non-Hodgkin's Lymphoma or Hodgkin's DiseaseAcute LeukaemiaMyelodysplastic SyndromeChronic Myeloid LeukemiaOsteomyelofibrosis
- Interventions
- Other: Placebo
- Locations
- 🇩🇪
Dr Ruth Seggewiss, Würzburg, Germany
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy
- First Posted Date
- 2007-10-08
- Last Posted Date
- 2009-03-02
- Lead Sponsor
- Swedish Orphan Biovitrum
- Registration Number
- NCT00540332
A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Subjects With Acute Leukemias Undergoing HSCT
- Conditions
- Leukemia
- Interventions
- 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
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2007-02-12
- Last Posted Date
- 2015-03-30
- Lead Sponsor
- Swedish Orphan Biovitrum
- Target Recruit Count
- 281
- Registration Number
- NCT00434161
- Locations
- 🇩🇪
Universitatsklinikum Leipzig, Leipzig, Germany
Drug Development Updates
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