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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 12
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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%
- •Age 18 years or older
- •ECOG performance status ≤ 2
- •Adequate hematologic, renal and liver function
- •Use of highly effective contraception
排除标准
- •Metastatic disease
- •Prior radiation therapy to the region of the study cancer
- •Subjects not receiving chemotherapy
- •Grade 2 or greater esophagitis at baseline
- •Inability to provide information in the electronic symptom-reporting device
- •Receiving any approved or investigational immunotherapy, targeted therapy, hormone therapy, or biologic therapy
- •Participation in another clinical trial or use of another investigational agent within 30 days of first does of GC4419
- •Malignant tumors other than the current lung cancer within the last 5 years
- •Previous diagnosis of pneumonitis
- •Untreated, active infectious disease requiring systemic anti-infective therapy
- •Untreated HIV or active hepatitis B/C
- •Females who are pregnant or breastfeeding
- •Known allergies or intolerance to chemotherapy and similar platinum-containing compounds
- •Requirement for concurrent treatment with nitrates or other drugs that may create a risk for a precipitous decrease in blood pressure
- •Clinically significant heart disease
研究组 & 干预措施
GC4419 (avasopasem manganese)
干预措施: GC4419 (avasopasem manganese) (Drug)
结局指标
主要结局
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.
时间窗: From the first radiation therapy fraction through the end of the study treatment period, which is estimated to be 6 weeks.
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
次要结局
- Number of Subjects With of Acute Radiation Esophagitis (Defined as Grade >/= 2; NCI CTCAE Version 5) Through 4 Weeks After Completion of Chemoradiotherapy(From the first radiation therapy fraction through 4 weeks after the completion of chemoradiotherapy, which is estimated to be 10 weeks)
- Number of Subjects With Acute Severe Radiation Esophagitis (Defined as Grade 3-4; NCI CTCAE Version 5) Through Completion of Chemoradiotherapy.(From the first radiation therapy fraction through the completion of chemoradiotherapy, which is estimated to be 6 weeks.)