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

NCT00109031 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2014-09-15

Study results available
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Summary

To evaluate whether palifermin (rHuKGF) administered as a single dose is non-inferior to 3 consecutive doses of palifermin in reducing the incidence of severe oral mucositis (World Health Organization \[WHO\] grade 3 and 4).

Conditions

Interventions

DRUG

palifermin

Administered as one daily intravenous bolus.

RADIATION

Total Body Irradiation

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

DRUG

Cyclophosphamide

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

DRUG

Etoposide

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

DRUG

Placebo

Administered as one daily intravenous bolus.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Swedish Orphan Biovitrum

    lead INDUSTRY

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2006-02-28
Completion
2010-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00109031 on ClinicalTrials.gov