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NCT04476797 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Study of SBRT and GC4711 for Centrally Located or Large NSCLC
A Phase 1 study, sponsored by Galera Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT04476797 is a Phase 1 study that was terminated before completion, run by Galera Therapeutics. The registered enrollment target is 47 participants.
The verdict
NCT04476797, a Phase 1 study, was terminated before completion, sponsored by Galera Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study Summary
GTI-4711-101 is a Phase I/II study of the safety of GC4711, its effect on in-field tumor response and its potential to reduce radiation-related pulmonary injury due to SBRT for lymph node negative (T1 to T3N0M0) peripheral or central localized (within 2cm of the proximal bronchial tree) NSCLC. After an open-label, Phase 1, safety cohort of 5 subjects has been completed, a randomized, placebo-controlled Phase 2 portion of 66 subjects will be conducted.
Interventions
- DRUG GC4711 +SBRT
- DRUG Placebo +SBRT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2020-10-18 |
| Est. Completion | 2023-11-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04476797
The ClinicalTrials.gov registry entry for NCT04476797 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 47 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 2 interventions - of which GC4711 +SBRT is the first listed.
NCT04476797 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04476797 about?
NCT04476797 is a clinical study titled "Phase I/II Study of SBRT and GC4711 for Centrally Located or Large NSCLC". GTI-4711-101 is a Phase I/II study of the safety of GC4711, its effect on in-field tumor response and its potential to reduce radiation-related pulmonary injury due to SBRT for lymph node negative (T1 to T3N0M0) peripheral or central localized (within 2cm of the proximal bronchial tree) NSCLC. Afte...
What is the current status of trial NCT04476797?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2020-10-18. Estimated completion is 2023-11-28.
What interventions are being tested in trial NCT04476797?
The interventions under investigation include: GC4711 +SBRT (DRUG), Placebo +SBRT (DRUG).
Who is sponsoring clinical trial NCT04476797?
This trial is sponsored by Galera Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
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