A Phase II Study of IL-18 in Melanoma Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 21
- 主要终点
- Overall response rate of tumor
研究概览
简要总结
This Phase II study is designed to evaluate the anti-tumor activity of three dose groups of SB-485232 (0.01, 0.1, and 1.0 mg/kg/day) administered intravenously as a single agent in subjects with previously untreated metastatic melanoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients must have melanoma that has spread beyond the original location and has not yet been treated.
- •Tissue from the spreading melanoma should have been tested to confirm it is melanoma.
排除标准
- •Patients having hepatitis or HIV infection.
- •Taking corticosteroids.
- •Patients with the primary site being occular melanoma or patients with melanoma of the brain.
结局指标
主要结局
Overall response rate of tumor
时间窗: Up to 12 months
Tumor response rate (RR) is defined as the percentage of participants achieving either a complete or partial response. Response was at least one measurable lesion as defined by response evaluation criteria for solid tumors (RECIST) criteria or a cutaneous or subcutaneous lesion of at least 1 centimeter (cm) in diameter in one dimension. A distinction was drawn between responses that are confirmed at a repeat assessment and those that are not. If there were unconfirmed responses, then a sensitivity analysis was performed excluding participants with unconfirmed responses. Analysis was performed by both Investigator and independent review committee (IRC). The results were compared and a confirmatory analysis has been presented.
次要结局
- Number of participants with progression free survival(Up to 12 months)
- Response duration of SB-485232 for tumor treatment(Up to 12 months)
- Time to response(Up to 12 months)
- Number of participants with adverse events (AEs), serious adverse events (SAEs), and death.(Up to 12 months)
- Change from Baseline In vital signs [systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and body temperature(BT)](Baseline (Day 1) to Day 15 and Day 28 of each cycle)
- Number of participants with toxicity grade shift of clinical laboratory parameters over period.(Baselie (Cycle1,Day 1), Day 2, Day 15 and Follow up (28 days after last dose of Cycle 13) of each cycle)
- Number of participants with immune response to SB485232 over period.(Day 15 of each cycle)