Columbus, Georgia 31904

  • 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


NCT ID:

NCT04225026


Primary Contact:

Study Chair
Jon T Holmlund, MD
Chief Medical Officer

Amanda Sanders
Phone: 484-870-9622
Email: asanders@galeratx.com


Backup Contact:

N/A


Location Contact:

Columbus, Georgia 31904
United States

Grayson Scott
Phone: 706-321-0495

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.