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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04225026
Recruitment Status : Terminated (Lack of study enrollment)
First Posted : January 13, 2020
Results First Posted : March 23, 2023
Last Update Posted : March 23, 2023
Sponsor:
Information provided by (Responsible Party):
Galera Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Esophagitis Drug: GC4419 (avasopasem manganese) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 19, 2019
Actual Primary Completion Date : December 28, 2021
Actual Study Completion Date : March 27, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Manganese

Arms and Interventions
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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 Name: Avasopasem manganese


Outcome Measures
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Primary Outcome Measures :
  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. [ 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



Secondary Outcome Measures :
  1. 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


  2. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04225026


Locations
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United States, Arizona
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Georgia
IACT Health
Columbus, Georgia, United States, 31904
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Missouri
Cancer Care St. Joseph/Mosaic Life Care
Saint Joseph, Missouri, United States, 64507
United States, New Jersey
Hackensack Meridian Health
Montclair, New Jersey, United States, 07753
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
United States, South Carolina
St. Francis Hospital
Greenville, South Carolina, United States, 29601
Spartanburg Regional Medical Center - Gibbs Cancer Center
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
United States, Washington
Providence Regional Cancer Partnership
Everett, Washington, United States, 98201
Sponsors and Collaborators
Galera Therapeutics, Inc.
Investigators
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Study Chair: Eugene Kennedy, MD Chief Medical Officer
  Study Documents (Full-Text)

Documents provided by Galera Therapeutics, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] February 24, 2021

More Information
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Responsible Party: Galera Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04225026    
Other Study ID Numbers: GTI-4419-203
First Posted: January 13, 2020    Key Record Dates
Results First Posted: March 23, 2023
Last Update Posted: March 23, 2023
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Manganese
Avasopasem manganese
 Trace Elements
Micronutrients
Physiological Effects of Drugs
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents