Clinical trialNCT01921426CompletedPhase 1Interventional

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

SponsorGalera Therapeutics, Inc.Enrollment30Squamous Cell Carcinoma of the Oral CavitySquamous Cell Carcinoma of the Oropharynx

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Aftab Mahmood, MD
Cancer Specialists of South Texas, P.A.
Principal Investigator
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Charles Kunos, MD, PhD
Summa Health System- Cooper Cancer Center
Principal Investigator
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Christopher M Lee, MD
Cancer Care Northwest
Principal Investigator
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Douglas Adkins, MD
Washington University School of Medicine
Principal Investigator
clinicaltrials.gov ↗
John Buatti, MD
University of Iowa
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗
Jon T. Holmlund, MD
Galera Therapeutics, Inc.
Study Director
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Larisa Greenberg, MD
West Penn Allegheny Health System
Principal Investigator
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Madhavi Venigalla, MD
Lakeland Regional Cancer Center
Principal Investigator
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Marcelo Bonomi, MD
Wake Forest University Health Sciences
Principal Investigator
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Pardip Pathare, MD
Norwalk Hospital
Principal Investigator
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Sanjiv Agarwala, MD
St. Luke's Cancer Center
Principal Investigator
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Weining Zhen, MD
University of Nebraska
Principal Investigator
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Yuhchyau Chen, MD, PhD
University of Rochester
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

10 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Lakeland Regional Cancer Center
Lakeland, Florida, United States
University of Iowa
Iowa City, Iowa, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
University of Rochester Medical Center
Rochester, New York, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Summa Health System- Cooper Cancer Center
Akron, Ohio, United States
St. Luke'S Cancer Center
Easton, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Cancer Care Northwest
Spokane, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

GC4419

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Aug 2013
Primary completion: 31 Jul 2015
Completion: 31 Aug 2016
Last update posted: 22 Sept 2016
Registered enrollment: 30
Registry id: NCT01921426

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.