NCT01776411已完成1 期
Phase I/II Clinical Study of Forodesine in Japanese Recurrent/Refractory Peripheral T-cell Lymphoma Patients
Mundipharma K.K.21 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 21
- 主要终点
- Objective response rate (ORR) based on evaluation by image assessment committee
研究概览
简要总结
Phase I portion:
To confirm safety and tolerability in recurrent/refractory peripheral T-cell lymphoma patients during repeated oral administration of forodesine 300 mg twice daily (600 mg/day) for 28 days, and determine the recommended dose. Also, to evaluate pharmacokinetics.
Phase II portion:
To evaluate the efficacy, safety, and pharmacokinetics of the recommended dosage regimen determined in the phase I portion. The primary efficacy endpoint shall be objective response rate (ORR).
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese patients at least 20 years of age.
- •Patients histologically diagnosed with peripheral T-cell lymphoma by pathological diagnosis of biopsied lesion. In this study, peripheral T-cell lymphoma is defined as the following mature T-cell/NK-cell neoplasms found in the 4th edition of the WHO Classification.
- •Recurrent/refractory patients with a treatment history of at least one regimen.
- •Patients with an enlarged lymph node or extranodal mass lesion clearly measurable in two perpendicular directions and greater than 1.5 cm in maximum diameter on computed tomography performed.
- •Patients expected to survive for at least 3 months.
- •ECOG PS 0-
- •Patients with adequate hemopoietic efficacy, liver and kidney function.
- •Patients from whom written consent has been obtained prior to study initiation.
排除标准
- •Patients who received a chemotherapy agent or a high dose of a systemic adrenocorticosteroid within 21 days prior to initial administration of the study drug.
- •Patients who received radiation therapy, phototherapy, or electron beam therapy within 21 days prior to initial administration of the study drug.
- •Patients who received another study drug within 28 days prior to initial administration of the study drug.
- •Patients who received antibody therapy within 100 days prior to initial administration of the study drug.
- •Patients with a history of allogeneic hematopoietic stem cell transplantation. Or patients with a history of autologous hematopoietic stem cell transplantation within 100 days prior to initial administration of the study drug.
- •Patients with cerebral metastasis or central nervous system lesion or a past history.
- •Patients with active multiple primary cancer. Or patients with a history of a malignant neoplasm other than peripheral T-cell lymphoma within the past 5 years.
- •Patients with severe cardiovascular disease.
- •Patients with congenital long QT syndrome.
- •Patients with QTcF >0.48 sec.
- •Patients positive for HBs antigen, HCV antibody or HIV antibody on immunological investigation. Or patients positive for either HBc antibody or HBs antibody, and showing DNA more than sensitivity in HBV-DNA assay.
- •Patients positive for CMV antigen on immunological investigation.
- •Patients with infectious disease requiring treatment consisting of intravenous administration of antibacterial agent, fungicide, or antiviral drug.
- •Patients with interstitial pneumonia or pulmonary fibrosis, or patients judged to have insufficient pulmonary function.
研究组 & 干预措施
Single Arm
Experimental
Drug: forodesine hydrochloride 600 mg / body/day (3 x 100 mg capsules twice daily)
干预措施: forodesine hydrochloride (Drug)
结局指标
主要结局
Objective response rate (ORR) based on evaluation by image assessment committee
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (21)
Loading locations...
相似试验
未知
1 期
Phase 1/2 clinical study of forodesine in Japanese recurrent/refractory peripheral T-cell lymphomarecurrent/refractory peripheral T-cell lymphomaJPRN-jRCT2080221940MUNDIPHARMA K.K.49
已完成
1 期
Forodesine Hydrochloride (BCX-1777) for B-Cell Acute Lymphoblastic LeukemiaB-cell Acute Lymphoblastic LeukemiaNCT00289562BioCryst Pharmaceuticals20
已完成
2 期
Phase II Study of Forodesine in Subjects With Chronic Lymphocytic Leukemia (CLL)Chronic Lymphocytic Leukemia (CLL)NCT00640523BioCryst Pharmaceuticals23
终止
2 期
Study of Forodesine Hydrochloride in Patients With Relapsed/Refractory Precursor T-Lymphoblastic Leukemia/Lymphoma Who Have Failed Two or More Prior Treatment RegimensLeukemiaLymphomaNCT00419081BioCryst Pharmaceuticals100
招募中
1 期
Phase 1 Trial of ST-001 nanoFenretinide in Relapsed/Refractory T-cell Non-Hodgkin LymphomaT-cell LymphomaCutaneous/Peripheral T-Cell LymphomaPeripheral T-cell LymphomaPeripheral T-Cell Lymphoma, Not ClassifiedPrimary Cutaneous T-cell LymphomaCutaneous T-Cell Lymphoma, UnspecifiedCutaneous T-cell LymphomaFollicular T-Cell LymphomaAngioimmunoblastic T-cell LymphomaSézary's DiseaseMycosis FungoidesNCT04234048SciTech Development, Inc.46