TerminatedPhase 2NCT04225026

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 (NSCLC) or Small Cell Lung Cancer (SCLC) treatable with chemoradiotherapy.

Checked against the public recordLast updated Mar 23, 2023 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 2
U.S. locations12
SponsorGalera Therapeutics, Inc.
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Galera Therapeutics, Inc.
Interventions being studied
Drug: GC4419 (avasopasem manganese)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: 1. 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 2. 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% 3. Age 18 years or older 4. ECOG performance status ≤ 2 5. Adequate hematologic, renal and liver function 6. Use of highly effective contraception Exclusion Criteria: 1. Metastatic disease 2. Prior radiation therapy to the region of the study cancer 3. Subjects not receiving chemotherapy 4. Grade 2 or greater esophagitis at baseline 5. Inability to provide information in the electronic symptom-reporting device 6. Receiving any approved or investigational immunotherapy, targeted therapy, hormone therapy, or biologic therapy 7. Participation in another clinical trial or use of another investigational agent within 30 days of first does of GC4419 8. Malignant tumors other than the current lung cancer within the last 5 years 9. Previous diagnosis of pneumonitis 10. Untreated, active infectious disease requiring systemic anti-infective therapy 11. Untreated HIV or active hepatitis B/C 12. Females who are pregnant or breastfeeding 13. Known allergies or intolerance to chemotherapy and similar platinum-containing compounds 14. Requirement for concurrent treatment with nitrates or other drugs that may create a risk for a precipitous decrease in blood pressure 15. Clinically significant heart disease

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Banner MD Anderson Cancer CenterGilbert, Arizona
  • Tampa General HospitalTampa, Florida
  • IACT HealthColumbus, Georgia
  • University of IowaIowa City, Iowa
  • University of LouisvilleLouisville, Kentucky
  • Cancer Care St. Joseph/Mosaic Life CareSaint Joseph, Missouri
  • Hackensack Meridian HealthMontclair, New Jersey
  • University Hospitals Cleveland Medical CenterCleveland, Ohio
  • St. Francis HospitalGreenville, South Carolina
  • Spartanburg Regional Medical Center - Gibbs Cancer CenterSpartanburg, South Carolina
  • University of Tennessee Medical CenterKnoxville, Tennessee
  • Providence Regional Cancer PartnershipEverett, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 23, 2023. Always confirm current availability with the study team.

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