Saint Joseph, Missouri 64507

  • Esophagitis

Purpose:

GTI-4419-203 will be an open-label, multi-center study to evaluate GC4419 administered intravenous (IV) for the reduction of radiation induced esophagitis in subjects receiving chemoradiotherapy for unresectable Stage 3A/3B or post-operative Stage 2B NSCLC, SCLC treatable with chemoradiotherapy.


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


Study is Available At:


Original ID:

GTI-4419-203


NCT ID:

NCT04225026


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Galera Therapeutics, Inc.


Oversight Authority:

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Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

39


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jon T Holmlund, MD
Study Chair
Chief Medical Officer

Study Dates

Start Date:December 19, 2019
Completion Date:March 27, 2022
Completion Type:Actual
Primary Completion Date:December 28, 2021
Primary Completion Type:Actual
Verification Date:June 2022
Last Changed Date:June 7, 2022
First Received Date:January 8, 2020

Study Outcomes

Outcome Type:Primary Outcome
Measure:Cumulative incidence of acute radiation esophagitis
Time Frame:From the first RT fraction through the end of the study treatment period, which is estimated to be 6
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:GC4419
Description:90 mg, by 60-minute IV infusion, prior to each fraction of RT
Arm Name:GC4419

Study Arms

Study Arm Type:Experimental
Arm Name:GC4419

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Galera Therapeutics, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: February 01, 2023

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