Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE)

Browse trials for

• Mucositis 488
• Stomatitis 400

Keywords

• Cancer
• Oncology

Mucositis

488 studies on the registry are indexed under Mucositis; 70 are open to participants now.

This study's enrollment of 47 is close to the median of 50 across 394 interventional studies indexed under Mucositis.

Lead sponsor

Swedish Orphan Biovitrum is the lead sponsor of 78 studies on the registry; 4 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.

Study arms

• Active comparator
  Palifermin 60 µg/kg for 3 days

  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.

  Drug: palifermin · Radiation: Total Body Irradiation · Drug: Cyclophosphamide · Drug: Etoposide · Drug: Placebo

• Experimental
  Palifermin 180 μg/kg on Day -1

  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.

  Drug: palifermin · Radiation: Total Body Irradiation · Drug: Cyclophosphamide · Drug: Etoposide · Drug: Placebo

• Experimental
  Palifermin 180 μg/kg on Day -2

  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.

  Drug: palifermin · Radiation: Total Body Irradiation · Drug: Cyclophosphamide · Drug: Etoposide · Drug: Placebo

• Experimental
  Palifermin 180 μg/kg on Day -3

  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.

  Drug: palifermin · Radiation: Total Body Irradiation · Drug: Cyclophosphamide · Drug: Etoposide · Drug: Placebo

Interventions

• Drugpalifermin

  Administered as one daily intravenous bolus.

  Also known as: Kepivance, Recombinant Human Keratinocyte Growth Factor (rHuKGF)

• RadiationTotal Body Irradiation

  To be delivered before the administration of chemotherapy in 6, 8, or 10 fractions over 3 or 4 days.

• DrugCyclophosphamide

  Cyclophosphamide is administered at a total dose of 100 mg/kg given in 1 dose on Day -2

• DrugEtoposide

  Etoposide may be administered (optional) as a single intravenous infusion over 4 hours on the day after the last fTBI fraction.

  Also known as: VP-16

• DrugPlacebo

  Administered as one daily intravenous bolus.

Primary outcomes

1. Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4)

   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.

   Time frame: Up to Day 28

Secondary outcomes

1. Duration of Severe Oral Mucositis (WHO Grade 3 and 4)

   The duration of severe oral mucositis (OM) was calculated as the number of days from the onset of severe OM (first time a WHO grade 3 or 4 was observed) to the day when severe OM was resolved (first time WHO grade 2 or less was observed after last WHO grade 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 3 or 4 during the study.

   Time frame: Up to Day 28

2. Area Under the Curve (AUC) of Mouth and Throat Soreness Score

   The Oral Mucositis Daily Questionnaire (OMDQ) is a self-reported tool that evaluates overall health, mouth and throat soreness (MTS) and activity limitations due to MTS. The OMDQ was completed once daily beginning with the first day of study drug administration through Day 28. The area under the curve of mouth and throat soreness score was assessed from the question "How much mouth and throat soreness did you experience in the past 24 hours?" Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness). A higher value in MTS AUC indicates worse self-assessed MTS.

   Time frame: From the first day of study drug administration through Day 28

3. Number of Participants With Parenteral or Transdermal Opioid Analgesic Use

   Includes nonprophylactic intravenous opioid analgesics (fentanyl, morphine, morphine sulphate, hydromorphone, meperidine) and transdermal opioid analgesics (fentanyl patch) for the indication of oral mucositis and dysphagia.

   Time frame: Up to Day 28

4. Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis

   Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until 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.

   Time frame: Up to Day 28

5. Duration of WHO Grade 2, 3 or 4 Oral Mucositis

   The duration of grade 2, 3 or 4 oral mucositis (OM) was calculated as the number of days from the onset of grade 2, 3 or 4 OM (first time a WHO grade 2, 3 or 4 was observed) to the day when WHO grade 2 - 4 OM was resolved (first time WHO grade less than 2 was observed after last WHO grade 2, 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 2, 3 or 4 during the study. OM was evaluated 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.

   Time frame: Up to Day 28

6. Number of Participants With WHO Grade 4 Oral Mucositis

   Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until 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.

   Time frame: Up to Day 28

Baseline characteristics