Study Stopped
Lack of study enrollment
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
1 other identifier
interventional
39
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2019
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 19, 2019
CompletedFirst Submitted
Initial submission to the registry
January 8, 2020
CompletedFirst Posted
Study publicly available on registry
January 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2022
CompletedResults Posted
Study results publicly available
March 23, 2023
CompletedMarch 23, 2023
June 1, 2022
2 years
January 8, 2020
November 17, 2022
March 22, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Subjects With of Acute Radiation Esophagitis (Defined as Grade >/= 2; NCI CTCAE Version 5) Through the End of Chemoradiotherapy for Non-Small Cell Lung (NSCLC) or Small Cell Lung Cancer (SCLC) When Avasopasem Was Added.
Those subjects in the primary efficacy population that experience acute radiation esophagitis (Grade \>/=2; NCI CTCAE version 5) through the end of chemoradiotherapy for NSCLC or SCLC when treated with avasopasem. NCI CTCAE Grading: Grade 1: asymptomatic; clinical or diagnostic observations only; intervention not indicated Grade 2: symptomatic; altered eating/swallowing; oral supplements indicated Grade 3: severely altered eating/swallowing; tube feeding, total parental nutrition (TPN) or hospitalization Grade 4: life-threatening consequences; urgent operative intervention indicated Grade 5: death
From the first radiation therapy fraction through the end of the study treatment period, which is estimated to be 6 weeks.
Secondary Outcomes (2)
Number of Subjects With of Acute Radiation Esophagitis (Defined as Grade >/= 2; NCI CTCAE Version 5) Through 4 Weeks After Completion of Chemoradiotherapy
From the first radiation therapy fraction through 4 weeks after the completion of chemoradiotherapy, which is estimated to be 10 weeks
Number of Subjects With Acute Severe Radiation Esophagitis (Defined as Grade 3-4; NCI CTCAE Version 5) Through Completion of Chemoradiotherapy.
From the first radiation therapy fraction through the completion of chemoradiotherapy, which is estimated to be 6 weeks.
Study Arms (1)
GC4419 (avasopasem manganese)
EXPERIMENTALInterventions
90 mg, by 60-minute IV infusion, prior to each fraction of RT
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
IACT Health
Columbus, Georgia, 31904, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Cancer Care St. Joseph/Mosaic Life Care
Saint Joseph, Missouri, 64507, United States
Hackensack Meridian Health
Montclair, New Jersey, 07753, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
St. Francis Hospital
Greenville, South Carolina, 29601, United States
Spartanburg Regional Medical Center - Gibbs Cancer Center
Spartanburg, South Carolina, 29303, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Providence Regional Cancer Partnership
Everett, Washington, 98201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Judy Schnyder, Sr. Vice President, Clinical Operations
- Organization
- Galera Therapeutics
Study Officials
- STUDY CHAIR
Eugene Kennedy, MD
Chief Medical Officer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2020
First Posted
January 13, 2020
Study Start
December 19, 2019
Primary Completion
December 28, 2021
Study Completion
March 27, 2022
Last Updated
March 23, 2023
Results First Posted
March 23, 2023
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share