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

Who is this study for? Adult patients with radiation and chemo-induced esophagitis
What treatments are being studied? GC4419
Status: Terminated
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
Banner MD Anderson Cancer Center
Gilbert
Florida
Tampa General Hospital
Tampa
Georgia
IACT Health
Columbus
Iowa
University of Iowa
Iowa City
Kentucky
University of Louisville
Louisville
Missouri
Cancer Care St. Joseph/Mosaic Life Care
Saint Joseph
New Jersey
Hackensack Meridian Health
Montclair
Ohio
University Hospitals Cleveland Medical Center
Cleveland
South Carolina
St. Francis Hospital
Greenville
Spartanburg Regional Medical Center - Gibbs Cancer Center
Spartanburg
Tennessee
University of Tennessee Medical Center
Knoxville
Washington
Providence Regional Cancer Partnership
Everett
Time Frame
Start Date: 2019-12-19
Completion Date: 2022-03-27
Participants
Target number of participants: 39
Treatments
Experimental: GC4419 (avasopasem manganese)
Sponsors
Leads: Galera Therapeutics, Inc.

This content was sourced from clinicaltrials.gov