An Open-Label, Single-arm, Multicenter Phase I Study of SCH 54031 (Pegylated Interferon Alfa-2b) as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (Protocol No. MK-4031 370 Also Known as SCH 54031, P08556)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 主要终点
- Number of Participants Experiencing Dose-limiting Toxicities (DLTs) - Induction Phase
研究概览
简要总结
This is a study to evaluate the safety and tolerability of peginterferon alfa-2b (PegIFN alfa-2b) as adjuvant treatment in Japanese participants with malignant melanoma after definitive surgical resection including complete lymphadenectomy. Participants on this study will initially receive PegIFN alfa-2b for 8 weeks (Induction Phase) and then may continue to receive PegIFN alfa-2b (Maintenance Phase) as long as they are experiencing clinical benefit (Up to 252 weeks). The primary hypothesis is that peginterferon alfa-2b administered on a weekly basis is safe and tolerated.
详细描述
The study was terminated after 118 weeks from the study start, during the maintenance phase, due to regulatory approval in Japan.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage II or III melanoma
- •Primary melanoma completely excised
- •Full lymphadenectomy within 84 days prior to initiation of study treatment
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
排除标准
- •Ocular melanoma or melanoma of the mucous membranes
- •Evidence of distant or non-regional lymph node metastases
- •In-transit melanoma
- •Previously treated with interferon alpha/beta, chemotherapy, hormonal therapy, radiotherapy or immunotherapy/vaccine for melanoma
研究组 & 干预措施
Participants receiving PegIFN alfa-2b
Participants receive PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
干预措施: PegIFN alfa-2b (Biological)
结局指标
主要结局
Number of Participants Experiencing Dose-limiting Toxicities (DLTs) - Induction Phase
时间窗: From first dose to end of induction phase; up to 8 Weeks
A DLT was an event (clinical or laboratory) that resulted in a change in the given dose.
次要结局
- Number of Participants Discontinuing Study Drug Because of AEs(From first dose to last dose of treatment; up to 260 Weeks)
- Safety: Number of Participants Experiencing Adverse Events (AEs)(From first dose through follow-up; up to 265 Weeks)