Clinical trial NCT04225026: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Esophagitis
Lead sponsor: Galera Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-13
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: From the first radiation therapy fraction through the end of the study treatment period, which is estimated to be 6 weeks.
Secondary outcomes:
measure: Number of Subjects With of Acute Radiation Esophagitis (Defined as Grade >/= 2; NCI CTCAE Version 5) Through 4 Weeks After Completion of Chemoradiotherapy
timeFrame: From the first radiation therapy fraction through 4 weeks after the completion of chemoradiotherapy, which is estimated to be 10 weeks
measure: Number of Subjects With Acute Severe Radiation Esophagitis (Defined as Grade 3-4; NCI CTCAE Version 5) Through Completion of Chemoradiotherapy.
timeFrame: From the first radiation therapy fraction through the completion of chemoradiotherapy, which is estimated to be 6 weeks.
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Columbus
country: United States
facility: IACT Health
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Saint Joseph
country: United States
facility: Cancer Care St. Joseph/Mosaic Life Care
state: Missouri
city: Montclair
country: United States
facility: Hackensack Meridian Health
state: New Jersey
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Greenville
country: United States
facility: St. Francis Hospital
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center - Gibbs Cancer Center
state: South Carolina
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Everett
country: United States
facility: Providence Regional Cancer Partnership
state: Washington
Study officials:
affiliation: Chief Medical Officer
name: Eugene Kennedy, MD
role: STUDY_CHAIR
References: