CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 5 enrolled
Drug / intervention
Placebo +3 moredrug
Likely dose
Cisplatin 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00626639
NCT00626639Phase 2Completed
CompareCT.gov

A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Weekly Doses of Palifermin (rHuKGF) for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer (HNC) Receiving Postoperative Radiotherapy With Concurrent Chemotherapy

Swedish Orphan Biovitrum·interventional·Posted Feb 29, 2008·Updated Jun 21, 2017

In Brief

A Phase 2 clinical trial evaluating Placebo, palifermin, and 2 other interventions for Mucositis and Head and Neck Cancer. Completed, enrolled 5 participants.

Detailed Summary

Oral Mucositis associated with adjuvant radiation and concurrent chemotherapy in postoperative Head and Neck setting

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMucositis, Head and Neck Cancer
Countries--
CollaboratorsAmgen

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 29, 2008
Enrollment StartJul 1, 2005
Primary CompletionMay 1, 2007
Study CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.3 years ago

Interventions

Placebodrug

Administered by intravenous (IV) bolus injection

palifermindrug

Administered by intravenous (IV) bolus injection

Radiotherapyradiation

Once daily irradiation of 20 centigray (cGy)/day x 33 fractions for a total target dose of 6600 cGy (conventional radiation therapy using standard fractionation \[one fraction per day\])

Cisplatindrug

100 mg/m\^2 intravenously (IV) on days 1, 22 and 43.