NCT02378038终止2 期
A Phase II Study of PNT2258 in Patients With Richter's Transformation (RT)
Sierra Oncology LLC - a GSK company9 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 9
- 主要终点
- Overall Response Rate
研究概览
简要总结
This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It is a multi-center, single-arm, 2-stage, open-label phase II investigation of PNT2258 to characterize anti-tumor activity and collect safety data on patients with Richter's Transformation.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed Richter's transformation (RT) from chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
- •Availability of fresh or archived tumor tissue.
- •FDG PET-CT (disease) positive baseline scan with measurable disease.
- •ECOG performance status of 0-
- •Evidence of disease progression at study entry.
- •Discontinuation of prior anticancer therapy for ≥ 7 days prior to C1D1 and recovered to ≤ CTCAE grade 2 (or baseline) from any acute or chronic toxicity associated with prior therapy.
- •Must have previously received at least one prior chemotherapeutic regimen for RT.
- •Previously untreated RT patients deemed ineligible for, or that refuse, intensive chemotherapy are eligible.
- •Adequate bone marrow, renal, and hepatic function.
- •Normal Coagulation profile.
- •Agreement to use acceptable methods of contraception during the study and for ≥ 120 days after the last dose of PNT2258 if sexually active and able to bear or beget children.
- •Ability to participate in the clinical study for a minimum of at least 2 cycles (6 weeks).
排除标准
- •Concurrent non-hematologic malignancies requiring treatment.
- •No more than 2 prior regimens for DLBCL.
- •Hodgkin's variant of Richter's lymphoma, accelerated CLL, composite lymphoma, interdigitating dendritic cell sarcoma, sarcoma, EBV-associated lymphoma or prolymphocytic transformation.
- •Ongoing risk of bleeding.
- •CNS or leptomeningeal involvement of lymphoma
- •Concurrent clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram or laboratory finding that, in the opinion of the investigator, could adversely affect the safety of the subject or impair the assessment of the study results.
- •Pregnancy or breast-feeding.
- •Previous exposure to PNT2258.
研究组 & 干预措施
PNT2258
Experimental
PNT2258 will be administered at 120 mg/m2 on days 1-5 of a 21-day cycle for 8 induction cycles followed by continuation phase therapy at a dose of 100 mg/m2 on days 1-4 of a 28-day cycle.
干预措施: PNT2258 (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: 2 months
Proportion of subjects with complete response (CR/CMR) or partial response (PR/PMR)
次要结局
- Disease Control Rate(2 months)
- Duration of Overall Response(2 months)
- Time to Response(2 months)
- Progression Free Survival(2 months)
- Overall Survival(2 months)
- Safety - Assessment of Adverse Events(2 months)
研究者
研究点 (9)
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