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

NCT01403064 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2021-05-11

Study results available
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Summary

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

Conditions

  • Oral Mucositis

Interventions

BIOLOGICAL

ALD518

IV

DRUG

0.9% saline

IV Infusion

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Jeffrey Smith, MD FRCP · Alder Biopharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-04-30
Completion
2014-03-31

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • Germany
  • Italy

Study Locations

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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 NCT01403064 on ClinicalTrials.gov