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Also known as Palifermin, rHuKGF, Kepivance
Recombinant Human Keratinocyte Growth Factor · 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 ...
Recombinant Human Keratinocyte Growth Factor is an investigational biologic developed by Amgen Inc. (ticker AMGN) for stomatitis, a painful inflammation of the mouth and throat. It is being studied in patients with hematologic malignancies who receive radiation and high-dose chemotherapy before peripheral blood stem cell transplantation.
Recombinant Human Keratinocyte Growth Factor is being developed to reduce oral mucositis, or stomatitis, in patients with hematologic malignancies undergoing peripheral blood stem cell transplantation after radiation and high-dose chemotherapy. It is in Phase 3 development and is not approved for this use.
Recombinant Human Keratinocyte Growth Factor targets F9, an exogenous protein target. It is a recombinant form of human keratinocyte growth factor designed to act on this target. The drug is being studied for its potential to reduce oral mucositis in patients receiving intensive cancer treatment.
Amgen Inc., which trades under the ticker AMGN, is the developer of Recombinant Human Keratinocyte Growth Factor. The company is studying the drug in a Phase 3 clinical trial for stomatitis in patients with hematologic malignancies undergoing stem cell transplantation.
Recombinant Human Keratinocyte Growth Factor is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The Phase 3 trial for stomatitis has been completed, and no active trials are currently listed for this drug.
Recombinant Human Keratinocyte Growth Factor has been studied in one completed Phase 3 trial, NCT00041665. The trial evaluated the drug to reduce oral mucositis in hematologic malignancy patients undergoing peripheral blood stem cell transplantation after radiation and high-dose chemotherapy. It was randomized and double-blind, with participants aged 18 years and older.