A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- response rate in overall skin disease
研究概览
简要总结
This is an open label, randomized phase II study designed to evaluate the tolerability and response rate of high-dose and low-dose regimens in patients with advanced cutaneous T-cell lymphoma (CTCL).
详细描述
This is an open label, randomized phase II study designed to evaluate the tolerability and response rate of high-dose and low-dose regimens in patients with advanced cutaneous T-cell lymphoma (CTCL) who have had progressive, recurrent, or persistent disease on or following 2 systemic therapies.
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
- •Adult patients with advanced CTCL
- •Have had at least 2 systemic therapies
- •Must have evaluable disease
- •Eastern Cooperative Oncology Group performance status 0-2
- •Adequate bone marrow, hepatic and renal function
- •At least 3 weeks from prior therapies
- •Not receiving topical steroids or have been on a stable dose of topical steroids for at least 2 weeks
- •Able to swallow capsules
- •At least 3 weeks from major surgery
- •Agree to practice effective contraception
- •Able to understand and willing to sign the informed consent form
排除标准
- •Receiving systemic steroids
- •Receiving topical or systemic retinoids or vitamin A
- •Receiving radiotherapy, biological therapy,or any other investigational agents
- •Uncontrolled intercurrent illness
- •Pregnant or lactating women
- •Known to be HIV-positive
- •Active hepatitis B and/or hepatitis C infection
研究组 & 干预措施
Arm A: High dose
High-dose (Arm A): 200 mg b.i.d. x 3 consecutive days per week for 2 weeks followed by 1-week rest
干预措施: Sapacitabine (Drug)
Arm B: High dose
Low-dose (Arm B): 100 mg b.i.d. x 3 consecutive days per week for 2 weeks followed by 1-week rest
干预措施: Sapacitabine (Drug)
结局指标
主要结局
response rate in overall skin disease
时间窗: over the course of study
Decrease of lesion from baseline
次要结局
未报告次要终点