NCT01037478已完成2 期
A Phase 2 Proof of Concept Study to Evaluate the Efficacy, Safety and Pharmacokinetics of the HDAC Inhibitor 4SC-201 in Patients With Relapsed or Refractory Hodgkin's Lymphoma
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
- 4SC AG
- 入组人数
- 37
- 试验地点
- 10
- 主要终点
- Determination of the best overall objective response rate (ORR) based on IWG criteria of Resminostat (4SC-201) in patients with refractory or relapsed Hodgkin's Lymphoma.
研究概览
简要总结
The purpose of this study is to determine whether Resminostat (4SC-201) is effective and safe in the treatment of relapsed or refractory Hodgkin's Lymphoma.
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
- •Patients must have histological or cytological evidence of Hodgkin's Lymphoma (all subtypes are acceptable)
- •Patients must have relapsed or refractory Hodgkin's Lymphoma (HL) defined as relapse following initial therapy or lack of response to first line therapy and treatment with second-line (salvage therapy). Patients may have also undergone high-dose chemotherapy with autologous stem cell transplantation at least 12 weeks prior to study entry
- •Patients must have measurable anatomical disease present on CT scan
- •Patients must have an ECOG Performance Score of 0, 1 or 2
排除标准
- •Patients who have received previous treatment with an HDAC inhibitor
- •Patients who have undergone allogeneic hematopoietic stem cell transplantation
- •Patients with known or suspected involvement of the CNS by HL
- •Patients treated with agents known to prolong the QT interval or with a confirmed QTcF > 450 msec
- •Patients with a history of other malignancies unless having undergone definitive treatment more than 5 years prior to entry into the study and without evidence of recurrent malignant disease, excluding patients with basal cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate with a current PSA < 0.1 ng/ml; or cervical intraepithelial neoplasia
- •Patients with a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory or inflammatory illness that could preclude their participation in the trial, pose an undue medical hazard or interfere with the interpretation of the trial results, including, but not limited to, patients with congestive heart failure (NYHA Class 3 or 4); unstable angina; cardiac arrhythmia; recent (within the preceding 6 months) myocardial infarction or stroke; hypertension requiring > 2 medications for adequate control; diabetes mellitus with > 2 episodes of ketoacidosis in the preceding 12 months
研究组 & 干预措施
Resminostat (4SC-201)
Experimental
oral administration
干预措施: Resminostat (4SC-201) (Drug)
结局指标
主要结局
Determination of the best overall objective response rate (ORR) based on IWG criteria of Resminostat (4SC-201) in patients with refractory or relapsed Hodgkin's Lymphoma.
时间窗: 12 weeks
次要结局
- Investigation of the safety and tolerability of repeated oral doses of Resminostat (4SC-201)(12 weeks)
- Assessment of the overall survival (OS)(12 weeks)
- Determination of progression free survival (PFS), including radiological and symptomatic progression(12 weeks)
- Determination of time to progression (TTP), including objective and symptomatic progression(12 weeks)
- Determination of duration of response (DOR)(12 weeks)
- Assessment of the pharmacokinetics of Resminostat (4SC-201) after oral dosing(12 weeks)
研究者
研究点 (10)
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