IRB #

STUDY00015152

Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Trial of the Effects of Intravenous GC4419 on the Incidence and Duration of Severe Oral Mucositis (OM) in Patients Receiving Post-Operative or Definitive Therapy with Single-Agent Cisplatin plus IMRT for Locally Advanced, Non-Metastatic Squamous Cell Carcinoma of the Oral Cavity or Oropharynx

Principal Investigator

John Holland

Study Purpose

To determine the effects of investigational medication GC4419 on oral mucositis in patients being treated with chemotherapy and radiation therapy for squamous cell carcinoma of the oral cavity or oropharynx.

Medical Condition(s)

Squamous cell carcinoma of the head and neck (SCCHN)

Eligibility Criteria

Patients with diagnosis of squamous cell carcinoma of the head and neck who are 18 years of age and older. Patients must not have received prior chemotherapy or radiation therapy but plan to be treated this way.

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

15 months

Minors Included

No

Contact

John Minger
Sr. Research Assistant
Oregon Health & Science University
Department of Radiation Medicine
mingerj@ohsu.edu
503-494-8756

Sponsor

Galera Therapeutics, Inc.

Recruitment End

12/31/2017

Compensation Provided

No


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