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

Esophagitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04225026
• Other study ID #: GTI-4419-203
• Status: Terminated
• Phase: Phase 2
• Start date: December 19, 2019
• Est. completion date: March 27, 2022

Study information

• Verified date: June 2022
• Source: Galera Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: March 27, 2022
• Est. primary completion date: December 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophagitis

Intervention

Drug:
• GC4419 (avasopasem manganese)
90 mg, by 60-minute IV infusion, prior to each fraction of RT

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	IACT Health	Columbus	Georgia
United States	Providence Regional Cancer Partnership	Everett	Washington
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	St. Francis Hospital	Greenville	South Carolina
United States	University of Iowa	Iowa City	Iowa
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	University of Louisville	Louisville	Kentucky
United States	Hackensack Meridian Health	Montclair	New Jersey
United States	Cancer Care St. Joseph/Mosaic Life Care	Saint Joseph	Missouri
United States	Spartanburg Regional Medical Center - Gibbs Cancer Center	Spartanburg	South Carolina
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Galera Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	From the first radiation therapy fraction through 4 weeks after the completion of chemoradiotherapy, which is estimated to be 10 weeks
Secondary	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.	From the first radiation therapy fraction through the completion of chemoradiotherapy, which is estimated to be 6 weeks.