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Also known as Recombinant Human Keratinocyte Growth Factor, rHuKGF, Kepivance, Recombinant Human Keratinocyte Growth Factor (rHuKGF), KGF
palifermin · 7 trials · 14 indications
Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until severe OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.
Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) 2 times weekly throughout radio/chemotherapy, and 2 times weekly thereafter until severe OM returned to grade ≤ 2 or until Week 15. During each evaluation, the following anatomical areas were assessed: upper lip; lower lip; right cheek; left cheek; right ventral \& lateral tongue; left ventral \& lateral tongue; floor of the mouth; hard palate; soft palate. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.
Participants underwent acute dysphagia assessments twice weekly during Weeks 1 through 7, and twice weekly thereafter (Weeks 8 through 12) and once weekly after Week 12 until dysphagia resolved to grade ≤ 1 but not beyond Week 16. Dysphagia (difficulty swallowing) was graded using the Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE v3.0) dysphagia scale according to the following: Grade 1: Symptomatic, able to eat regular diet; Grade 2: Symptomatic and altered eating/swallowing (e.g., altered dietary habits, oral supplements), IV fluids indicated \<24 hours; Grade 3: Symptomatic and severely altered eating/swallowing (e.g., inadequate oral caloric or fluid intake), IV fluids, tube feedings, or total parenteral nutrition (TPN) indicated ≥24 hours; Grade 4: Life-threatening consequences (e.g., obstruction, perforation).
GVHD was graded using the modified Keystone Criteria weekly during the first 2 months after stem cell infusion, then every other week until Day 100. Severity was determined clinically (based on physical exam and laboratory serum values) and from biopsies of affected organs whenever possible. The degree of GVHD in individual organs was scored by at least 2 assessors. Grade 3 GVHD = total bilirubin 3.1 - 15.0 mg/dL or ≥ 1000 mL/day diarrhea or severe abdominal pain with/without ileus. Grade 4 GVHD = skin involvement with bullous formation or total bilirubin \> 15.0 mg/dL.
| Arm | Type | Description |
|---|---|---|
| Palifermin 60 µg/kg for 3 days | ACTIVE_COMPARATOR | Palifermin 60 µg/kg plus placebo to match the total volume equivalent to a 180 µg/kg dose on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC). Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0. |
| Palifermin 180 μg/kg on Day -1 | EXPERIMENTAL | Palifermin 180 μg/kg on Day -1 and matched placebo on Days -2 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0. |
| Palifermin 180 μg/kg on Day -2 | EXPERIMENTAL | Palifermin 180 μg/kg on Day -2 and placebo on Days -1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0. |
| Palifermin 180 μg/kg on Day -3 | EXPERIMENTAL | Palifermin 180 μg/kg on Day -3 and placebo on Days -1 and -2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0. |
| Palifermin | EXPERIMENTAL | Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course. |
| Placebo | PLACEBO_COMPARATOR | Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course. |
| Control Group | PLACEBO_COMPARATOR | 50 subjects to receive matched placebo 3 days prior to the first day (day 1) of each cycle of 5-FU/ LV chemotherapy. |
| Name | Type | Description |
|---|---|---|
| palifermin | DRUG | Administered as one daily intravenous bolus. |
| Total Body Irradiation | RADIATION | To be delivered before the administration of chemotherapy in 6, 8, or 10 fractions over 3 or 4 days. |
| Cyclophosphamide | DRUG | Cyclophosphamide is administered at a total dose of 100 mg/kg given in 1 dose on Day -2 |
| Etoposide | DRUG | Etoposide may be administered (optional) as a single intravenous infusion over 4 hours on the day after the last fTBI fraction. |
| Placebo | DRUG | Administered as one daily intravenous bolus. |
| cisplatin chemotherapy | DRUG | Commercially available cisplatin was administered as an intravenous infusion at a dose of 100 mg/m\^2 on Days 1, 22, and 43. |
| Radiotherapy | RADIATION | Radiotherapy was delivered in 200 cGy daily fractions, 5 days a week. |
| Recombinant Human Keratinocyte Growth Factor | DRUG | - |
| Paclitaxel | DRUG | - |
| Carboplatin | DRUG | - |
| Conditioning Regimen | OTHER | Each participant received 1 of the following conditioning regimens: * Cyclophosphamide (Cy) / total body irradiation (TBI) with and without etoposide (VP-16) * TBI/VP-16 * Melphalan (Mel)/TBI (TBI regimens must include fully ablative doses ie \> 1100 cGy; sequence of chemotherapy/radiation (CT/RT) flexible) * Busulfan (Bu)/Cy * Bu/Mel (non-TBI but fully ablative regimens/doses \[Mel dose \> 140 mg/m\^2\]) * Fludarabine (Flu)/Mel (non-TBI but fully ablative regimens/doses \[Mel dose \> 140 mg/m\^2\]) |
| Allogeneic stem cell transplant | PROCEDURE | Allogeneic marrow/peripheral blood progenitor cell transplantation |
| Methotrexate | DRUG | - |
Inclusion Criteria: * Written informed consent * Subjects with: non-Hodgkin's lymphoma, Hodgkin's disease, acute myelogenous leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, chronic lymphocytic leukemia, or multiple myeloma * Minimum of 1.5 x 10\^6 CD34+ cells/kg cryopreserved ...
Top 2 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/GEH200521 |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
Palifermin is studied for the reduction of oral mucositis, a painful mouth condition, in patients with cancer. Research indications include head and neck cancer, colon cancer, hematologic malignancies, graft versus host disease, and dysphagia. It is given to lessen mucosal damage associated with cancer treatment.
Palifermin targets FGFR2, the fibroblast growth factor receptor 2, and acts as an agonist at this receptor. By activating FGFR2 signaling, it is designed to stimulate epithelial cell growth and repair in the mouth and gastrointestinal lining, which is the proposed basis for reducing oral mucositis.
Palifermin is developed by Amgen Inc., which trades on Nasdaq under the ticker AMGN. Amgen is the sponsor behind the clinical program evaluating palifermin across oncology supportive care indications, including oral mucositis and graft versus host disease.
Palifermin has been evaluated in Phase 3 clinical development. A Phase 3 trial in advanced head and neck cancer enrolled 241 patients, and a Phase 3 single-dose study called PROMISE enrolled 47 patients. Both of those trials are completed, and no palifermin trials are currently active.
Palifermin has been studied in completed trials including NCT00131638, a Phase 3 study in advanced head and neck cancer with 241 patients, and NCT00109031, the Phase 3 PROMISE study in cancer, lymphoma, and leukemia. Phase 2 trials include NCT00393822 in colon cancer and NCT00189488 in graft versus host disease.
Palifermin is also known by the brand name Kepivance. Both names refer to the same Amgen compound, a recombinant human keratinocyte growth factor studied for oral mucositis and related conditions in cancer patients. Searches for either name point to the same drug asset.