Completed PHASE3 INTERVENTIONAL 2-arm NCT00101582

Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer

Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (rHuKGF) for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer Receiving Radiotherapy With Concurrent Chemotherapy (RT/CT)

Sponsor: Amgen

Conditions Head and Neck Cancer Mucositis Solid Tumors Squamous Cell Carcinoma Stomatitis

Interventions Placebo Radiotherapy cisplatin chemotherapy palifermin

Updated 7 times since 2017 Last updated: Aug 19, 2016 Started: Aug 31, 2005 Primary completion: Sep 30, 2007 Completion: Aug 31, 2016

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00101582, this PHASE3 trial focuses on Head and Neck Cancer and Mucositis and remains completed. Sponsored by Amgen, it has been updated 7 times since 2005, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

Change History

7 versions recorded

Jan 2026 — Present [monthly]

Completed PHASE3
Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Aug 2005

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Amgen
Swedish Orphan Biovitrum

Data source: Swedish Orphan Biovitrum

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.