Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
GTI-4419-203
- NCT ID:
NCT04225026
Conditions
Interventions
Drug | Synonyms | Arms |
---|
GC4419 | | GC4419 |
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.
Trial Arms
Name | Type | Description | Interventions |
---|
GC4419 | Experimental | | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
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 weeks |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Galera Therapeutics, Inc. |
Last Updated
March 29, 2021