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

Primary Purpose

Esophagitis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GC4419 (avasopasem manganese)
Sponsored by
Galera Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophagitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Banner MD Anderson Cancer Center
  • Tampa General Hospital
  • IACT Health
  • University of Iowa
  • University of Louisville
  • Cancer Care St. Joseph/Mosaic Life Care
  • Hackensack Meridian Health
  • University Hospitals Cleveland Medical Center
  • St. Francis Hospital
  • Spartanburg Regional Medical Center - Gibbs Cancer Center
  • University of Tennessee Medical Center
  • Providence Regional Cancer Partnership

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GC4419 (avasopasem manganese)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Subjects With of Acute Radiation Esophagitis (Defined as Grade >/= 2; NCI CTCAE Version 5) Through 4 Weeks After Completion of Chemoradiotherapy
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
Number of Subjects With Acute Severe Radiation Esophagitis (Defined as Grade 3-4; NCI CTCAE Version 5) Through Completion of Chemoradiotherapy.
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.

Full Information

First Posted
January 8, 2020
Last Updated
March 22, 2023
Sponsor
Galera Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04225026
Brief Title
Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis Due to Chemoradiotherapy for Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of study enrollment
Study Start Date
December 19, 2019 (Actual)
Primary Completion Date
December 28, 2021 (Actual)
Study Completion Date
March 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galera Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GC4419 (avasopasem manganese)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GC4419 (avasopasem manganese)
Other Intervention Name(s)
Avasopasem manganese
Intervention Description
90 mg, by 60-minute IV infusion, prior to each fraction of RT
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
From the first radiation therapy fraction through the end of the study treatment period, which is estimated to be 6 weeks.
Secondary Outcome Measure Information:
Title
Number of Subjects With of Acute Radiation Esophagitis (Defined as Grade >/= 2; NCI CTCAE Version 5) Through 4 Weeks After Completion of Chemoradiotherapy
Description
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
Time Frame
From the first radiation therapy fraction through 4 weeks after the completion of chemoradiotherapy, which is estimated to be 10 weeks
Title
Number of Subjects With Acute Severe Radiation Esophagitis (Defined as Grade 3-4; NCI CTCAE Version 5) Through Completion of Chemoradiotherapy.
Description
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.
Time Frame
From the first radiation therapy fraction through the completion of chemoradiotherapy, which is estimated to be 6 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Kennedy, MD
Organizational Affiliation
Chief Medical Officer
Official's Role
Study Chair
Facility Information:
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
IACT Health
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Cancer Care St. Joseph/Mosaic Life Care
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64507
Country
United States
Facility Name
Hackensack Meridian Health
City
Montclair
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
St. Francis Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Spartanburg Regional Medical Center - Gibbs Cancer Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Providence Regional Cancer Partnership
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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