A Phase I/II Open Label, Multi-Center Study For The Evaluation Of Pf-3512676 (CPG 7909) In Patients With Stage Ib To Iva Cutaneous T-Cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 42
- 主要终点
- Safety: Adverse events, vital signs, clinical and laboratory parameters, physical exams, and ECGs
研究概览
简要总结
To assess the effect of CPG 7909 Injection on Cutaneous T-cell lymphoma and the safety of CPG 7909 Injection in patients with this cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients 18 years or older with biopsy (histopathologically) confirmed cutaneous T-cell lymphoma (limited to mycosis fungoides (MF)) who have had prior therapy with at least one and no more than 3 systemic treatments.
排除标准
- •Patients with visceral involvement, serious infection or illness including human immunodeficiency virus infection, or a Karnofsky Performance Status (KPS) < 60 will be excluded.
研究组 & 干预措施
Phase I: 0.08 mg/kg
Escalating dose groups: 0.08 mg/kg PF-3512676 Injection
干预措施: PF-3512676 (Drug)
Phase I: 0.16 mg/kg
Escalating dose groups: 0.16 mg/kg PF-3512676 Injection
干预措施: PF-3512676 (Drug)
Phase I: 0.24 mg/kg
Escalating dose groups: 0.24 mg/kg PF-3512676 Injection
干预措施: PF-3512676 (Drug)
Phase I: 0.28 mg/kg
Escalating dose groups: 0.28 mg/kg PF-3512676 Injection
干预措施: PF-3512676 (Drug)
Phase I: 0.32 mg/kg
Escalating dose groups: 0.32 mg/kg PF-3512676 Injection
干预措施: PF-3512676 (Drug)
Phase I: 0.36 mg/kg
Escalating dose groups: 0.36 mg/kg PF-3512676 Injection
干预措施: PF-3512676 (Drug)
Phase II: 10 mg
Phase II: 10 mg flat dose (random assignment in Phase II)
干预措施: PF-3512676 (Drug)
Phase II: 25 mg
Weekly subcutaneous injections of 25 mg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
干预措施: PF-3512676 (Drug)
结局指标
主要结局
Safety: Adverse events, vital signs, clinical and laboratory parameters, physical exams, and ECGs
时间窗: 24 weeks
Efficacy: Evaluate tumor response as measured by the Composite Assessment of Index Lesion Disease Severity (CA). The primary endpoint will be the overall tumor response rate as assessed by the CA.
时间窗: 24 weeks
次要结局
- Secondary efficacy endpoints include disease response assessed by the PGA, duration of overall response, duration of CCR, duration of PR, time to response and time to progression of disease.(indeterminate)