A Phase 1, Open-Label Safety, Pharmacokinetic and Efficacy Study of TAS4464 in Patients With Multiple Myeloma or Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 7
- 主要终点
- Efficacy of TAS4464, defined as Objective Response Rate (ORR) per IWG criteria (NHL) and IMWG criteria (MM). This will take into consideration routine assessments including: imaging scans, physical exams, blood tests, urine tests and biopsy results
研究概览
简要总结
The Phase 1 portion of this study will determine the safety of TAS4464 and the most appropriate dose for patients with Multiple Myeloma or Lymphoma.
详细描述
The trial was put on Clinical Hold prior to Phase 2 due to cases of drug induced liver injury meeting the criteria for Hy's Law.
Background and Rationale:
• TAS4464 is an investigational NEDD8 activating enzyme (NAE) inhibitor, a compound which may affect cancer cell growth and survival. Thus, TAS4464 may help in the treatment of cancer.
Phase 1:
Primary:
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
- •Provide written informed consent
- •Women of child-bearing potential must have a negative pregnancy test
- •Multiple Myeloma:
- •Confirmed diagnosis of Multiple Myeloma with measurable disease, having been treated with at least two prior lines of therapy.
- •Confirmed diagnosis of Non-Hodgkin Lymphoma with measurable disease, having been treated with at least one anthracycline-based therapy, with relapse or progression since the last treatment received.
排除标准
- •Any of the following treatments, within the specified time frame, prior to the first dose of TAS4464:
- •Major surgery within 28 days
- •Radiation/chemotherapy within 21 days
- •Monoclonal antibodies within 28 days
- •Corticosteroid administration >20 mg/day of prednisone or equivalent within 14 days
- •Proteasome inhibitors within 14 days
- •Immunomodulatory agents within 7 days
- •Stem cell transplant within 3 months
- •Current immunosuppressive treatment for graft versus host disease
- •Current use of an investigational agent
- •Active graft versus host disease
- •Known serious illness or medical condition
- •Prior treatment with TAS4464 or known hypersensitivity to any of its inactive ingredients or drugs similar in class
- •Pregnant or breast-feeding female
研究组 & 干预措施
TAS4464
干预措施: TAS4464 (Drug)
结局指标
主要结局
Efficacy of TAS4464, defined as Objective Response Rate (ORR) per IWG criteria (NHL) and IMWG criteria (MM). This will take into consideration routine assessments including: imaging scans, physical exams, blood tests, urine tests and biopsy results
时间窗: Up to 5 years
Number of patients experiencing any dose-limiting toxicities, during dose escalation period, to determine maximum tolerated dose of TAS4464, using NCI CTCAE criteria, laboratory testing, performance status assessments, and other routine visit procedures
时间窗: Completion of Cycle 1 (28 days)
次要结局
未报告次要终点