Palifermin

Generic Name: Palifermin
Study IDStudied Indication or DiseasePhaseStudy TitleSynopsis
20010133Oral mucositis (OM) induced by myeloablative therapy1A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Pediatric Subjects with Acute Leukemias Undergoing Myeloablative Therapy and Allogeneic Hematopoietic Stem Cell Transplant (HCST)
20020402Mucositis associated with radiation therapy and concurrent chemotherapy in subjects with HNC3A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduction of Oral Mucositis in Subjects with Advanced Head and Neck Cancer Receiving Radiotherapy with Concurrent Chemotherapy (RT/CT)
20030185Dysphagia caused by radiation therapy (RT) with concurrent chemotherapy2A Phase 2 Study to Evaluate the Efficacy and Safety of Palifermin (Recombinant Human Keratinocyte Growth Factor) in the Reduction of Dysphagia in Patients Receiving Concurrent Chemoradiotherapy followed by Consolidation Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
20040118Mucositis associated with adjuvant radiation and chemotherapy in postoperative HNC setting3

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer Receiving Adjuvant Radiotherapy and Chemotherapy (RT/CT)

20040122Oral mucositis (OM) associated with multi-cycle chemotherapy with fluoropyrimidine containing regimens2/3

A Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Palifermin (Recombinant Human Keratinocyte Growth Factor) for Reduction of Oral Mucositis in Subjects with Stage 2B or 3 Locally Advanced, Colon Cancer Receiving 5-FU and Leucovorin as Adjuvant Therapy

20040124Oral Mucositis associated with adjuvant radiation and concurrent chemotherapy in postoperative HNC setting1/2A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduction of Oral Mucositis in Subjects with Locally Advanced Head and Neck Cancer (HNC) Receiving Postoperative Radiotherapy with Concurrent Chemotherapy
20040212Oral Mucositis induced by radiotherapy and chemotherapy3bPalifermin for the Reduction of Oral Mucositis In Singledose Evaluation (PROMISE): A Randomized, Blinded, Active-control Trial of Palifermin (rHuKGF) to Evaluate Oral Mucositis in Subjects with Hematologic Malignancies Undergoing Fractionated Total Body Irradiation (fTBI) and High Dose Chemotherapy with Autologous Peripheral Blood Progenitor Cell (PBPC) Transplantation
20040213Graft-Versus-Host-Disease in subjects with Hematologic malignancies undergoing Allogeneic Transplantation2A Randomized, Double-blind, Placebo-controlled Trial to Evaluate Palifermin (rHuKGF) in the Reduction of Acute Graft Versus Host Disease in Subjects with Hematologic Malignancies Undergoing Allogeneic Marrow/PBPC Transplantation
20050100Oral mucositis induced by high-dose chemotherapy in subjects with NHL or MM4An Open-label, Single-arm Study of Palifermin for Reduction of Mucositis in Subjects with Non -Hodgkins Lymphoma (NHL) or Multiple Myeloma (MM) Undergoing High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell (PBSC) Transplantation
20050137Oral mucositis1An Open-label, Randomized, 2-Part, Parallel Design Study to Characterize the Effect of Heparin on Palifermin Pharmacokinetics and the Effect of Palifermin on Heparin Pharmacodynamics in Healthy Subjects