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NCT03340974 · ClinicalTrials.gov registry record · Phase 1
Pilot Dose Escalation Trial of Stereotactic Body Radiation Therapy (SBRT) in Combination With GC4419 in Pancreatic Cancer
A Phase 1 study, sponsored by Galera Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT03340974: Completed Phase 1 study, sponsored by Galera Therapeutics.
NCT03340974 is a Phase 1 study that has completed, run by Galera Therapeutics. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03340974, a Phase 1 study, has completed, sponsored by Galera Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
The purpose of the phase I/II clinical study is to determine the best dose of fractionated stereotactic radiation therapy (SBRT) given either with Avasopasem manganese (GC4419) or placebo to patients who have been diagnosed with locally advanced pancreatic cancer.
Primary Outcome
Number of Common Terminology Criteria Adverse Events (CTCAE) that are grade 3 or 4 gastro-intestinal (GI) toxicities or deaths. CTCAE grade 3 or 4 gastro-intestinal toxicities are those adverse events that a subject may experience in their gastro-intestinal system that have been graded by the treating investigator to be severe (Grade 3) or life-threatening (Grade 4).
Interventions
- DRUG Placebo
- DRUG GC4419
- RADIATION Stereotactic Radiation Therapy (SBRT) 50 Gy
- RADIATION Stereotactic Radiation Therapy (SBRT) 55 Gy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2018-02-12 |
| Est. Completion | 2021-05-26 |
| Phase | Phase 1 |
What the finished NCT03340974 record still lists
NCT03340974 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03340974 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03340974 about?
NCT03340974 is a clinical study titled "Pilot Dose Escalation Trial of Stereotactic Body Radiation Therapy (SBRT) in Combination With GC4419 in Pancreatic Cancer". The purpose of the phase I/II clinical study is to determine the best dose of fractionated stereotactic radiation therapy (SBRT) given either with Avasopasem manganese (GC4419) or placebo to patients who have been diagnosed with locally advanced pancreatic cancer.
What is the current status of trial NCT03340974?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2018-02-12. Estimated completion is 2021-05-26.
What interventions are being tested in trial NCT03340974?
The interventions under investigation include: Placebo (DRUG), GC4419 (DRUG), Stereotactic Radiation Therapy (SBRT) 50 Gy (RADIATION), Stereotactic Radiation Therapy (SBRT) 55 Gy (RADIATION).
Who is sponsoring clinical trial NCT03340974?
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 NCT03340974's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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