Trials / Terminated
TerminatedNCT04225026
Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis Due to Chemoradiotherapy for Lung Cancer
A Phase 2a Open-Label Trial of the Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis in Subjects Receiving Chemoradiotherapy for Lung Cancer
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Galera Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GC4419 (avasopasem manganese) | 90 mg, by 60-minute IV infusion, prior to each fraction of RT |
Timeline
- Start date
- 2019-12-19
- Primary completion
- 2021-12-28
- Completion
- 2022-03-27
- First posted
- 2020-01-13
- Last updated
- 2023-03-23
- Results posted
- 2023-03-23
Locations
12 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04225026. Inclusion in this directory is not an endorsement.