Safety and Efficacy of ALD518 for Reducing Oral Mucositis in Head and Neck Cancer Subjects

ClinicalTrials.gov ID: NCT01403064

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Official title

A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of ALD518 in the Reduction of Oral Mucositis in Subjects With Head and Neck Cancer Receiving Concomitant Chemotherapy and Radiotherapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to evaluate the safety and efficacy of ALD518 in modifying the course of oral mucositis in subjects with head and neck cancer receiving concomitant chemotherapy and radiotherapy

Study identification

NCT ID: NCT01403064
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 2
Lead sponsor: CSL Behring; Industry
Enrollment: 76 participants

Conditions and interventions

Conditions

Oral Mucositis

Interventions

ALD518 Biological
0.9% saline Drug

Biological · Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 2011 (Type not available)
Primary completion: Apr 2013 (Actual)
Completion: Mar 2014 (Actual)
Last update posted: May 11, 2021

2011 – 2014

United States locations

U.S. sites: 13
U.S. states: 10
U.S. cities: 13

Facility	City	State	ZIP	Site status
Morton Plant Mease Health Care	Clearwater	Florida	33756	—
Dana Farber Cancer Institute	Boston	Massachusetts	02215	—
Karmanos Cancer Center	Detroit	Michigan	48201	—
Detroit Clinical Research Center	Farmington Hills	Michigan	48336	—
John Theurer Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey	07601	—
University of New Mexico Cancer Center	Albuquerque	New Mexico	87106	—
Mount Sinai School of Medicine	New York	New York	10029	—
SUNY Upstate Medical University	Syracuse	New York	13210	—
Temple University Hospital	Philadelphia	Pennsylvania	19140	—
Spartanburg Regional Medical Center	Spartanburg	South Carolina	29303	—
Cancer Specialists of Southern Texas	Corpus Christi	Texas	78412	—
University of Texas Southwestern Medical Center	Dallas	Texas	75390	—
VA Puget Sound Health Care Syatem	Seattle	Washington	98108	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 18 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01403064, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 11, 2021 · Synced Nov 15, 2026