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
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Safety and tolerability of ALD518, including incidence of adverse events, serious adverse events and clinically significant laboratory abnormalities
Participants will be followed for the duration of the trial, an expected average of 12 months
Yes
Jeffrey Smith, MD FRCP
Study Director
Alder Biopharmaceuticals, Inc.
United States: Food and Drug Administration
ALD518-CLIN-009
NCT01403064
July 2011
April 2013
Name | Location |
---|---|
Mount Sinai School of Medicine | New York, New York 10029 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Morton Plant Mease Health Care | Clearwater, Florida 33756 |
Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Temple University Hospital | Philadelphia, Pennsylvania 19140 |
SUNY Upstate Medical University | Syracuse, New York 13210 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
University of Texas Southwestern Medical Center | Dallas, Texas |
John Theurer Cancer Center at Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Karmanos Cancer Center | Detroit, Michigan 48201 |
Detroit Clinical Research Center | Farmington Hills, Michigan 48336 |
Cancer Specialists of Southern Texas | Corpus Christi, Texas 78412 |
VA Puget Sound Health Care Syatem | Seattle, Washington 98108 |