NCT00511082已完成1 期
Phase 1 Study of OPB-31121 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
- To investigate the safety and tolerability of OPB-31121 following repeated oral administration of OPB-31121 in patients Non-Hodgkin's Lymphoma(NHL) or Multiple Myeloma(MM)
- To determine the potential dose-limiting toxicities and maximum-tolerated dose in patients treated with OPB-31121
- To determine the pharmacokinetics and anti-tumor efficacy of OPB-31121 in patients
详细描述
The study is designed as a single-center,open-label,phase 1 dose-escalation study to assess the safety,tolerability,pharmacokinetics, and anti-tumor efficacy of OPB-31121 in patients with relapsed or refractory NHL or MM.
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 relapsed or refractory NHL histologically confirmed.
- •Relapsed or refractory NHL or MM patients must have experienced treatment failure.
- •Chinese patients aged 18 years or older at the time of giving informed consent.
- •Performance status score of 0-2 according to the incriteria of he Eastern Cooperative Oncology Group(ECOG)
- •Life expectancy of longer than 3 months.
- •Patients must have adequate vital organ function.
- •Patients are willing to comply with the visit schedules of the hospitalization and outpatient clinic.
- •Patients with prior chemotherapy, immunotherapy, cytokines therapy, major surgery, and radiotherapy to the index lesion must have been completed for a minimum period of 4 weeks and recovered from the related toxicity (NCI CTCAE grade 0 or 1) before registration.
- •Patients with systemic corticosteroid therapy (>10 mg prednisone or equivalent) must have been completed for a minimum of 1 weeks and recovered from the related toxicity (NCI CTCAE grade 0 or 1) before registration.
- •Patients with prior stem cell transplantation must be at least 8 weeks and have recovered from the related toxicity (NCI CTCAE grade 0 or 1) before registration.
排除标准
- •Patients are receiving another investigational agent or who have received another investigational agent within 6 months.
- •Patients are receiving concurrent chemotherapy, biologic agents, or radiotherapy.
- •Patients are receiving concurrent administration of warfarin.
- •NHL or MM patients who are candidates for autologous stem cell transplantation are excluded from the study.
- •Patients with other primary malignancy except squamous or basal cell skin cancer or cervical cancer in situ.
- •Patients with acute lymphoblastic lymphoma/leukaemia, POEMS syndrome or plasma cell leukaemia.
- •Lymphoma patients with symptomatic CNS involvement.
- •Patients with uncontrolled intercurrent illness.
- •Known HIV-positive/AIDS patients.
- •Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the study period.
- •Patients will not or are unable to use appropriate contraceptive methods during the study period and for at least 6 months after completion of the study
- •Patients need to receive any of the following treatments or therapeutic agents during the study period:
- •Anti-cancer drugs other than the study drug
- •Systemic corticosteroid therapy (>10 mg prednisone or equivalent)
- •Radiotherapy as primary therapy
- •Immunotherapy
- •Surgical therapy
- •CYP3A4 and CYP2C9 enzyme inducers or inhibitors,or substrates, and CYP2B6, CYP2C8, and CYP2D6 substrates.
研究组 & 干预措施
Treatment group
Experimental
Investigational Medicinal Product: OPB-31121 25-mg tablet, 100-mg tablet Dose: OPB-31121 50, 100, 200, 400, 600, 800, and 1000 mg Dosage regimen: ingestion with water after breakfast Treatment period: 4 weeks Mode of Administration: oral administration of OPB-31121 once daily
干预措施: OPB-31121 (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: 4 weeks
次要结局
- 1.Pharmacokinetic Endpoints 2.Efficacy Endpoints & Response Criteria(4 weeks)
研究者
研究点 (1)
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