NCT00649584终止1 期
A Phase I Dose Escalation Study of Weekly SGN-35 Monotherapy and in Combination With Gemcitabine in Patients With Relapsed/Refractory CD30-positive Hematologic Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Seagen Inc.
- 入组人数
- 44
- 试验地点
- 5
- 主要终点
- Incidence of adverse events and laboratory abnormalities
研究概览
简要总结
This study will examine the safety profile of SGN-35 alone and in combination with gemcitabine. The study will test increasing doses of SGN-35 given weekly to small groups of patients.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed CD30-positive hematologic malignancy.
- •Patients with HL must have failed systemic chemotherapy.
- •Patients with other CD30-positive malignancies (including ALCL) must be beyond first remission or refractory to front line chemotherapy.
- •Patients must have measurable disease of at least 1.5 cm as documented by radiographic technique.
排除标准
- •Current diagnosis of primary cutaneous ALCL (systemic ALCL eligible).
- •History of allogeneic stem cell transplant.
- •Patients who have had previous treatment with any anti-CD30 antibody.
研究组 & 干预措施
1
Experimental
SGN-35 alone or in combination with gemcitabine
干预措施: SGN-35 (Drug)
1
Experimental
SGN-35 alone or in combination with gemcitabine
干预措施: gemcitabine (Drug)
结局指标
主要结局
Incidence of adverse events and laboratory abnormalities
时间窗: 1 month after last dose
次要结局
- PK profile(2 months after last dose)
- Immunogenicity (anti-SGN-35 antibodies)(1 month after last dose)
- Anti-tumor activity(1 month after last dose)
研究者
研究点 (5)
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