Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04225026 · ClinicalTrials.gov registry record · Phase 2
Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis Due to Chemoradiotherapy for Lung Cancer
A Phase 2 study, sponsored by Galera Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
NCT04225026: Clinical Trial Phase 2 study, sponsored by Galera Therapeutics.
NCT04225026 is a Phase 2 study that was terminated before completion, run by Galera Therapeutics. The registered enrollment target is 39 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04225026, a Phase 2 study, was terminated before completion, sponsored by Galera Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
Study Summary
GTI-4419-203 will be an open-label, multi-center study to evaluate GC4419 (avasopasem manganese) administered intravenous (IV) for the reduction of radiation induced esophagitis in subjects receiving chemoradiotherapy for unresectable Stage 3A/3B or post-operative Stage 2B Non-Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC) treatable with chemoradiotherapy.
Primary Outcome
Those subjects in the primary efficacy population that experience acute radiation esophagitis (Grade \>/=2; NCI CTCAE version 5) through the end of chemoradiotherapy for NSCLC or SCLC when treated with avasopasem. NCI CTCAE Grading: Grade 1: asymptomatic; clinical or diagnostic observations only; intervention not indicated Grade 2: symptomatic; altered eating/swallowing; oral supplements indicated Grade 3: severely altered eating/swallowing; tube feeding, total parental nutrition (TPN) or hosp
Interventions
- DRUG GC4419 (avasopasem manganese)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2019-12-19 |
| Est. Completion | 2022-03-27 |
| Phase | Phase 2 |
Why NCT04225026 stopped before completion
NCT04225026 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 1 intervention - of which GC4419 (avasopasem manganese) is the first listed.
NCT04225026 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04225026 about?
NCT04225026 is a clinical study titled "Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis Due to Chemoradiotherapy for Lung Cancer". GTI-4419-203 will be an open-label, multi-center study to evaluate GC4419 (avasopasem manganese) administered intravenous (IV) for the reduction of radiation induced esophagitis in subjects receiving chemoradiotherapy for unresectable Stage 3A/3B or post-operative Stage 2B Non-Small Cell Lung Cancer...
What is the current status of trial NCT04225026?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2019-12-19. Estimated completion is 2022-03-27.
What interventions are being tested in trial NCT04225026?
The interventions under investigation include: GC4419 (avasopasem manganese) (DRUG).
Who is sponsoring clinical trial NCT04225026?
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 NCT04225026's enrollment target sits among peer trials
39 1459th of 2000 higher than 534 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03465592 · 39 participants · Phase 1
Trial of Nivolumab Following Partially Human Leukocyte Antigen (HLA) Mismatched BMT in Children & Adults With Sarcoma
- NCT03961776 · 39 participants
Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems
- NCT04050280 · 39 participants · Phase 2
CLAG-GO for Patients With Persistent, Relapsed or Refractory AML
- NCT04190862 · 39 participants · Phase 1
E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI