Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis Due to Chemoradiotherapy for Lung Cancer
Stopped early · Phase 2
Conditions studied: Esophagitis
In brief
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.
Key facts
- Study ID
- NCT04225026
- Run by
- Galera Therapeutics, Inc.
- People needed
- 39
- Starts
- 2019-12-19
- Expected to finish
- 2022-03-27
- Last updated by the study team
- 2023-03-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects scheduled to be treated with (definitive or adjuvant) radiation therapy in combination with chemotherapy once daily for Stage 3A/3B or post-operative Stage 2B NSCLC or limited stage SCLC
- Treatment plan for subjects show that 5 cm of the esophagus for at least one surface, is included in the 60 Gy isodose volume. Dose volume histograms show esophagus dose exposure meet V38>30% and/or V60>20%
- Age 18 years or older
- ECOG performance status ≤ 2
- Adequate hematologic, renal and liver function
- Use of highly effective contraception
You may not qualify if…
- Metastatic disease
- Prior radiation therapy to the region of the study cancer
- Subjects not receiving chemotherapy
- Grade 2 or greater esophagitis at baseline
- Inability to provide information in the electronic symptom-reporting device
- Receiving any approved or investigational immunotherapy, targeted therapy, hormone therapy, or biologic therapy
- Participation in another clinical trial or use of another investigational agent within 30 days of first does of GC4419
- Malignant tumors other than the current lung cancer within the last 5 years
- Previous diagnosis of pneumonitis
- Untreated, active infectious disease requiring systemic anti-infective therapy
- Untreated HIV or active hepatitis B/C
- Females who are pregnant or breastfeeding
- Known allergies or intolerance to chemotherapy and similar platinum-containing compounds
- Requirement for concurrent treatment with nitrates or other drugs that may create a risk for a precipitous decrease in blood pressure
- Clinically significant heart disease
Where it is running
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
- Tampa General Hospital — Tampa, Florida, United States
- IACT Health — Columbus, Georgia, United States
- University of Iowa — Iowa City, Iowa, United States
- University of Louisville — Louisville, Kentucky, United States
- Cancer Care St. Joseph/Mosaic Life Care — Saint Joseph, Missouri, United States
- Hackensack Meridian Health — Montclair, New Jersey, United States
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
- St. Francis Hospital — Greenville, South Carolina, United States
- Spartanburg Regional Medical Center - Gibbs Cancer Center — Spartanburg, South Carolina, United States
- University of Tennessee Medical Center — Knoxville, Tennessee, United States
- Providence Regional Cancer Partnership — Everett, Washington, United States
Full record on ClinicalTrials.gov
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