An Open Label Multi-Center Study of the Effects of GC4419 When Administered to Reduce the Incidence and Severity of Severe Oral Mucositis Associated With Chemo RT for Locally Advanced, Non-Metastatic Head and Neck Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 24
- 主要终点
- Incidence of Treatment Emergent AE's
研究概览
简要总结
GTI-4419-202 is a Phase 2 open-label study of the effects of GC4419 (IV) when administered in combination with IMRT and cisplatin to up to subjects with head and neck cancer, who are at high risk for Severe Oral Mucositis (SOM)
详细描述
Subjects will receive 90 mg GC4419 per day (60 min IV infusion to complete within 60 minutes prior to IMRT), concurrent with daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks, plus cisplatin administered 100 mg/m2 once every three weeks for 3 doses or 40 mg/m2 once weekly for 6-7 doses (Investigator's choice).
All subjects will be assessed twice weekly for Oral Mucositis (OM) per WHO grading criteria until 28 days post end of study treatment period (last day of IMRT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Pathologically-confirmed diagnosis of locally advanced squamous cell carcinoma of the head and neck that will be treated with cisplatin plus concurrent IMRT.
- •Treatment plan to receive a continuous course of IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy.
- •Patients who have had prior surgery may be eligible,
- •Treatment plan to receive standard cisplatin monotherapy administered either every three weeks (100 mg/m2 for 3 doses) or weekly (40 mg/m2 for 6-7 doses).
- •Age 18 years or older
- •ECOG performance status ≤ 2
- •Adequate hematologic function
- •Adequate renal and liver function Alkaline phosphatase ≤ 2.5 ULN
排除标准
- •Metastatic disease
- •Prior radiotherapy to the region of the study cancer or adjacent anatomical sites
- •Prior induction chemotherapy or plans for chemotherapy to be administered only sequentially with IMRT
- •Planned concurrent chemotherapy other than single agent cisplatin
- •Receiving any approved or investigational anti-cancer agent
- •Concurrent participation in another interventional clinical study
- •Inability to eat soft solid food at baseline for reasons other than mouth soreness after surgery or dental procedures
- •Complete reliance on parenteral or gastrointestinal tube-delivered nutrition at baseline
- •Malignant tumors other than head and neck cancer (HNC) within the last 5 years
- •Active infectious disease excluding oral candidiasis
- •Presence of oral mucositis at baseline.
- •Known history of human immunodeficiency virus (HIV) or active hepatitis B/C
- •Female patients who are pregnant or breastfeeding
- •Known allergies or intolerance to cisplatin and similar platinum-containing compounds
- •Requirement for concurrent treatment with nitrates or other drugs that may, in the judgment of the treating Investigator, create a risk for a precipitous decrease in blood pressure.
研究组 & 干预措施
Open Label Active Arm
90mg GC4419 by IV
干预措施: Intensity-modulated radiation therapy (IMRT) (Radiation)
Open Label Active Arm
90mg GC4419 by IV
干预措施: Cisplatin (Drug)
结局指标
主要结局
Incidence of Treatment Emergent AE's
时间窗: First dose of study medication through the 30 days following the last dose of IMRT, GC4419, or cisplatin (whichever occurs last) which is estimated to be 11 weeks
Number of Subjects with at Least One Treatment Emergent Adverse Event (TEAE)
次要结局
- Cumulative Incidence of Severe OM(From start of Intensity-modulated radiation therapy (IMRT) through approximately 30 fractions which is estimated to be 6-7 weeks.)