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NCT02508389 · ClinicalTrials.gov registry record · Phase 2
A Study of the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer
A Phase 2 study, sponsored by Galera Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 223
- Enrollment target
NCT02508389: Completed Phase 2 study, sponsored by Galera Therapeutics.
NCT02508389 is a Phase 2 study that has completed, run by Galera Therapeutics. The registered enrollment target is 223 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02508389, a Phase 2 study, has completed, sponsored by Galera Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 223 participants
- Enrollment target
Study Summary
The purpose of the phase 2, GT-201 clinical study is to determine if GC4419 administered prior to intensity-modulated radiation therapy (IMRT) reduces the incidence, duration, and severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.
Primary Outcome
Assessed from the first determination of ≥Grade 3 OM to the first instance of non-severe OM (≤Grade 2), without a subsequent instance of ≥Grade 3
Interventions
- DRUG Placebo
- DRUG Cisplatin
- RADIATION Intensity-Modulated Radiation Therapy
- DRUG Low Dose GC4419: 30mg/day
- DRUG High Dose GC4419: 90mg/day
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 223 participants |
| Start Date | 2015-10-12 |
| Est. Completion | 2019-08-29 |
| Phase | Phase 2 |
What the finished NCT02508389 record still lists
NCT02508389 is an interventional study that assigns participants to a tested intervention. The registered 223 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT02508389 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02508389 about?
NCT02508389 is a clinical study titled "A Study of the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer". The purpose of the phase 2, GT-201 clinical study is to determine if GC4419 administered prior to intensity-modulated radiation therapy (IMRT) reduces the incidence, duration, and severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic s...
What is the current status of trial NCT02508389?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 223 participants. The study started on 2015-10-12. Estimated completion is 2019-08-29.
What interventions are being tested in trial NCT02508389?
The interventions under investigation include: Placebo (DRUG), Cisplatin (DRUG), Intensity-Modulated Radiation Therapy (RADIATION), Low Dose GC4419: 30mg/day (DRUG), High Dose GC4419: 90mg/day (DRUG).
Who is sponsoring clinical trial NCT02508389?
This trial is sponsored by Galera Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02508389's enrollment target sits among peer trials
223 274th of 2000 higher than 1,727 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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