A Phase 1 Dose Escalation Study of GC4419 in Combination With Chemoradiation for Squamous Cell Cancer of the Head & Neck

Summary

The purpose of this study is to determine the safety, tolerability, and the highest dose of GC4419 that can be given to patients with squamous cell cancer of the head and neck who are receiving standard radiation therapy and chemotherapy. This study will also evaluate GC4419 for the following:

* Effect on the incidence and severity of radiation induced oral mucositis;
* Effect on the response rate of squamous cell cancer of the head and neck who are receiving radiation therapy and chemotherapy;
* Total concentrations of GC4419 that can be achieved in the blood;
* Changes in proteins and genetics associated with oral mucositis;
* Impact on delayed toxicities of radiation (dry mouth and reduced ability to fully open the mouth);
* Observe changes in genetic and molecular markers of oral mucositis;
* Observe the usage of extra health resources (e.g., unplanned ER visits, feeding tube use, etc.) of study patients;
* Assess the overall quality of life in study patients with oral mucositis.

Conditions

• Squamous Cell Carcinoma of the Oral Cavity
• Squamous Cell Carcinoma of the Oropharynx

Interventions

DRUG

GC4419

GC4419 is a novel, highly stable manganese-containing macrocyclic ligand complex with a molecular weight of 483, whose activity mimics that of naturally occurring superoxide dismutase (SOD) enzymes. It is therefore a prototype of a new class of drugs termed selective SOD mimetics. GC4419 selectively removes superoxide anions without reacting with other reactive oxygen species, including nitric oxide, hydrogen peroxide, and peroxynitrite.

Sponsors & Collaborators

• Galera Therapeutics, Inc.

  lead INDUSTRY

Principal Investigators

• Jon T. Holmlund, MD · Galera Therapeutics, Inc.

• Madhavi Venigalla, MD · Lakeland Regional Cancer Center

• Weining Zhen, MD · University of Nebraska

• Douglas Adkins, MD · Washington University School of Medicine

• Pardip Pathare, MD · Norwalk Hospital

• Sanjiv Agarwala, MD · St. Luke's Cancer Center

• Charles Kunos, MD, PhD · Summa Health System- Cooper Cancer Center

• Yuhchyau Chen, MD, PhD · University of Rochester

• John Buatti, MD · University of Iowa

• Aftab Mahmood, MD · Cancer Specialists of South Texas, P.A.

• Larisa Greenberg, MD · West Penn Allegheny Health System

• Marcelo Bonomi, MD · Wake Forest University Health Sciences

• Christopher M Lee, MD · Cancer Care Northwest

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-08-31

Primary Completion

2015-07-31

Completion

2016-08-31

Countries

• United States

Study Locations