Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis Due to Chemoradiotherapy for Lung Cancer

March 22, 2023 updated by: Galera Therapeutics, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center
    • Florida
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
    • Georgia
      • Columbus, Georgia, United States, 31904
        • IACT Health
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Missouri
      • Saint Joseph, Missouri, United States, 64507
        • Cancer Care St. Joseph/Mosaic Life Care
    • New Jersey
      • Montclair, New Jersey, United States, 07753
        • Hackensack Meridian Health
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
    • South Carolina
      • Greenville, South Carolina, United States, 29601
        • St. Francis Hospital
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Regional Medical Center - Gibbs Cancer Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center
    • Washington
      • Everett, Washington, United States, 98201
        • Providence Regional Cancer Partnership

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GC4419 (avasopasem manganese)
Drug: GC4419 (avasopasem manganese)
90 mg, by 60-minute IV infusion, prior to each fraction of RT
Other Names:
  • Avasopasem manganese

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: From the first radiation therapy fraction through the end of the study treatment period, which is estimated to be 6 weeks.

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With of Acute Radiation Esophagitis (Defined as Grade >/= 2; NCI CTCAE Version 5) Through 4 Weeks After Completion of Chemoradiotherapy
Time Frame: From the first radiation therapy fraction through 4 weeks after the completion of chemoradiotherapy, which is estimated to be 10 weeks

Those subjects in the in the primary efficacy population that experience Grade >/= 2 (NCI CTCAE version 5) acute radiation esophagitis through 4 weeks after completion 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 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.
Time Frame: From the first radiation therapy fraction through the completion of chemoradiotherapy, which is estimated to be 6 weeks.

Those subjects in the per protocol population that experienced Grade 3-4 acute radiation esophagitis through the completion of chemoradiotherapy.

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 completion of chemoradiotherapy, which is estimated to be 6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galera Therapeutics, Inc.

Investigators

  • Study Chair: Eugene Kennedy, MD, Chief Medical Officer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2019

Primary Completion (Actual)

December 28, 2021

Study Completion (Actual)

March 27, 2022

Study Registration Dates

First Submitted

January 8, 2020

First Submitted That Met QC Criteria

January 8, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTI-4419-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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