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Palifermin · 6 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. |
| 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 ...
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Palifermin is an investigational small molecule being studied for the reduction of oral mucositis in patients with head and neck cancer, colon cancer, and graft versus host disease. It is also being evaluated in conditions such as dysphagia and other cancers. Palifermin is developed by Amgen Inc. and is currently in Phase 2 clinical development.
Palifermin is a small molecule developed by Amgen Inc. that targets pathways involved in mucositis and graft versus host disease. It is being studied for its potential to reduce oral mucositis in patients with head and neck cancer and colon cancer, as well as to reduce acute graft versus host disease in patients with hematologic malignancies.
Palifermin is developed by Amgen Inc., a biopharmaceutical company listed on NASDAQ under the ticker symbol AMGN. Amgen is conducting clinical trials to evaluate Palifermin for the reduction of oral mucositis in cancer patients and for the reduction of acute graft versus host disease in patients undergoing allogeneic transplantation.
Palifermin is currently in Phase 2 clinical development. It has completed multiple trials, including Phase 3 studies for oral mucositis in head and neck cancer and Phase 2 studies for graft versus host disease and colon cancer. Palifermin is not yet approved and remains an investigational drug.
Palifermin has been studied in several clinical trials, including NCT00101582 and NCT00131638 for oral mucositis in head and neck cancer, NCT00189488 for acute graft versus host disease, and NCT00393822 for oral mucositis in colon cancer. All trials are completed, with enrollment ranging from 100 to 241 participants.
Palifermin is the same as Kepivance, a brand name for the drug. Kepivance is the marketed name for palifermin, which is developed by Amgen Inc. Palifermin is being studied for the reduction of oral mucositis in cancer patients and for graft versus host disease.