NCT01733238已完成2 期
PNT2258-02: A Pilot Phase II Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
Sierra Oncology LLC - a GSK company3 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2012年11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
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 3
- 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 study is a multi-center, nonrandomized, open-label, pilot Phase II investigation of PNT2258 to characterize anti-tumor activity and collect safety data on patients with relapsed or refractory lymphoma.
详细描述
PNT2258 will be administered at a dose of 120 mg/m2, as a 3-hour intravenous (IV) infusion on days 1-5 of a 21-day cycle. Treatment may continue (unless there is disease progression or the occurrence of unacceptable toxicity) for a total of 6 cycles of therapy.
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
- •Written informed consent must be obtained from the patient.
- •Participants must be ≥18 years of age.
- •Morphologically confirmed diagnosis of non-Hodgkin's lymphoma (NHL).
- •At least a single measureable tumor mass (long axis > 1.5 cm).
- •An FDG-PET positive baseline scan.
- •a. A positive scan is defined per revised Cheson criteria as "focal or diffuse FDG uptake above background in a location incompatible with normal anatomy or physiology, without a specific standardized uptake value cutoff".
- •Disease that has relapsed after administration of primary therapy that included:
- •Rituximab and
- •CHOP, EPOCH, bendamustine or similar chemotherapy or subsequent salvage regimen.
- •Note: Relapse is defined as progression after a complete response to therapy or radiographic evidence of active disease after a partial response or stable disease.
- •Have received three or fewer complete courses of systemic cytotoxic regimens. Note: Rituximab (alone or in combination with cytotoxic chemotherapy) is not considered a cytotoxic regimen.
- •No previous exposure to PNT
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Have discontinued all prior anti-cancer therapies for at least 21 days; biologic therapy for at least 4 half-lives of the drug(s); radio-immunotherapy (10 weeks); autologous stem cell transplantation (SCT) (3 months) and must be at a stable baseline regarding any acute toxicity associated with prior therapy.
- •Adequate organ function including:
- •Hematologic Function: absolute neutrophil count (ANC) ≥ 1.5 x 109/L prior to treatment. Platelets ≥ 100 x 109/L.
- •Hepatic: Total Bilirubin ≤ 1.5 x ULN and serum transaminase levels ≤ 2.5 x upper limits of normal (ULN).
- •Renal: Serum creatinine ≤2 x ULN or creatinine clearance ≥ 60 mL/min/1.73 m2 for subjects with serum creatinine levels above 2x ULN.
排除标准
- •Candidates for HDT and autologous SCT. Note: Patients who progressed > 3 months after high-dose therapy (HDT)/SCT are eligible.
- •Concurrent malignancies requiring treatment.
- •Symptomatic central nervous system (CNS) or leptomeningeal involvement of lymphoma.
- •Concurrent serious medical conditions (as determined by the Principal Investigator) including, but not limited to, HIV-associated lymphoma; active bacterial, fungal or viral infections.
- •Signs and symptoms of heart failure characterized as greater than New York Heart Association (NYHA) Class I.
- •History of myocardial infarct or prolonged corrected QT (QTc) interval (>450 milliseconds (msecs) for males or >470 msecs for females) or other significant cardiac abnormalities.
- •Women who are pregnant or breast-feeding.
研究组 & 干预措施
PNT2258
Experimental
PNT2258 120 mg/m2 will be administered as a 2-hour intravenous infusion on days 1-5 of a 21-day cycle. Treatment may continue (unless there is disease progression or the occurrence of unacceptable toxicity) for a total of 6 cycles of therapy.
干预措施: PNT2258 (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: 39 months
Subjects who had a best response of complete response or partial response as assessed by the investigator
次要结局
- Progression-free Survival(39 months)
研究者
研究点 (3)
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