Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis Due to Chemoradiotherapy for Lung Cancer
NCT ID: NCT04225026
Last Updated: 2023-03-23
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
39 participants
INTERVENTIONAL
2019-12-19
2022-03-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GC4419 (avasopasem manganese)
GC4419 (avasopasem manganese)
90 mg, by 60-minute IV infusion, prior to each fraction of RT
Interventions
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GC4419 (avasopasem manganese)
90 mg, by 60-minute IV infusion, prior to each fraction of RT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Galera Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eugene Kennedy, MD
Role: STUDY_CHAIR
Chief Medical Officer
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Tampa General Hospital
Tampa, Florida, United States
IACT Health
Columbus, Georgia, United States
University of Iowa
Iowa City, Iowa, United States
University of Louisville
Louisville, Kentucky, United States
Cancer Care St. Joseph/Mosaic Life Care
Saint Joseph, Missouri, United States
Hackensack Meridian Health
Montclair, New Jersey, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
St. Francis Hospital
Greenville, South Carolina, United States
Spartanburg Regional Medical Center - Gibbs Cancer Center
Spartanburg, South Carolina, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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GTI-4419-203
Identifier Type: -
Identifier Source: org_study_id
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