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NCT01921426 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Dose Escalation Study of GC4419 in Combination With Chemoradiation for Squamous Cell Cancer of the Head & Neck
A Phase 1 study of Squamous Cell Carcinoma of the Oropharynx and Squamous Cell Carcinoma of the Oral Cavity, sponsored by Galera Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 10
- Study locations
NCT01921426: Completed Phase 1 study of Squamous Cell Carcinoma of the Oropharynx and Squamous Cell Carcinoma of the Oral Cavity, sponsored by Galera Therapeutics.
NCT01921426 is a Phase 1 study of Squamous Cell Carcinoma of the Oropharynx and Squamous Cell Carcinoma of the Oral Cavity that has completed, run by Galera Therapeutics. The registered enrollment target is 30 participants, below the 74-participant average among 6 other Squamous Cell Carcinoma of the Oropharynx trials with a reported enrollment target (59% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01921426, a Phase 1 study of Squamous Cell Carcinoma of the Oropharynx and Squamous Cell Carcinoma of the Oral Cavity, has completed, sponsored by Galera Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 10
- Study locations
Study 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.
Primary Outcome
GC4419 will be evaluated to determine safety, tolerability, and the maximum tolerated dose of GC4419 that can be administered to patients with squamous cell cancer of the head and neck who are receiving concurrent radiation (50-70 Gy, administered daily x 5 \[M-F\], in 2.0-2.2 Gy fractions) and chemotherapy (cisplatin, 80-100mg/m2, q3 weeks or weekly cisplatin 30-40mg/m2 x 6 weeks). Patients will receive 14 - 35 doses of GC4419 in serially ascending cohorts for dose and duration, which correspon
Conditions Studied
Interventions
- DRUG GC4419
Study Locations (10)
Pennsylvania
- St. Luke's Cancer Center - Easton
- Allegheny General Hospital - Pittsburgh
Florida
- Lakeland Regional Cancer Center - Lakeland
Iowa
- University of Iowa - Iowa City
Missouri
- Washington University School of Medicine - St Louis
Nebraska
- University of Nebraska Medical Center - Omaha
New York
- University of Rochester Medical Center - Rochester
North Carolina
- Wake Forest Baptist Health - Winston-Salem
Ohio
- Summa Health System- Cooper Cancer Center - Akron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2013-08 |
| Est. Completion | 2016-08 |
| Phase | Phase 1 |
What the finished NCT01921426 record still lists
NCT01921426 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 74-participant average among 6 other Squamous Cell Carcinoma of the Oropharynx trials with a reported enrollment target (59% lower).
The record links to 2 conditions, with Squamous Cell Carcinoma of the Oropharynx appearing as the primary indexed condition, and to 1 intervention - of which GC4419 is the first listed.
NCT01921426 lists 10 locations in 9 states (Pennsylvania, Florida, Iowa).
Frequently Asked Questions
What is clinical trial NCT01921426 about?
NCT01921426 is a clinical study titled "A Phase 1 Dose Escalation Study of GC4419 in Combination With Chemoradiation for Squamous Cell Cancer of the Head & Neck". 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: * Ef...
What is the current status of trial NCT01921426?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2013-08. Estimated completion is 2016-08.
What conditions does trial NCT01921426 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma of the Oropharynx, Squamous Cell Carcinoma of the Oral Cavity.
What interventions are being tested in trial NCT01921426?
The interventions under investigation include: GC4419 (DRUG).
Who is sponsoring clinical trial NCT01921426?
This trial is sponsored by Galera Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01921426 being conducted?
This trial has 10 study locations across Florida, Iowa, Missouri, Nebraska, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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