A Phase 1 Dose Escalation Study of GC4419 in Combination With Chemoradiation for Squamous Cell Cancer of the Head & Neck
Public ClinicalTrials.gov record NCT01921426. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 Dose Escalation Study of GC4419 in Combination With Radiation and Chemotherapy for Squamous Cell Cancers of the Head and Neck.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01921426
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 30 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2013
- Primary completion
- Jun 30, 2015
- Completion
- Jul 31, 2016
- Last update posted
- Sep 21, 2016
2013 – 2016
United States locations
- U.S. sites
- 10
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Lakeland Regional Cancer Center | Lakeland | Florida | 33805 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | — |
| Summa Health System- Cooper Cancer Center | Akron | Ohio | 44304 | — |
| St. Luke's Cancer Center | Easton | Pennsylvania | 18045 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| Cancer Care Northwest | Spokane | Washington | 99216 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01921426, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 21, 2016 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01921426 live on ClinicalTrials.gov.