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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 is a Phase 2 study that has completed, run by Galera Therapeutics. The registered enrollment target is 223 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG Cisplatin
  • RADIATION Intensity-Modulated Radiation Therapy
  • DRUG Low Dose GC4419: 30mg/day
  • DRUG High Dose GC4419: 90mg/day

Trial Details

FieldValue
Enrollment Target 223 participants
Start Date 2015-10-12
Est. Completion 2019-08-29
Phase Phase 2

Sponsor

Galera Therapeutics

11 total trials

What the Registry Record Tells You About NCT02508389

The ClinicalTrials.gov registry entry for NCT02508389 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 223 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Galera Therapeutics, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.

NCT02508389 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.