A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Oral Tomivosertib (eFT-508) in Subjects With Hematological Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 10
- 主要终点
- Maximum Tolerated Dose and/or Recommended Dose within the tested Tomivosertib (eFT-508) dose range
研究概览
简要总结
This clinical trial is a Phase 1-2, open-label, sequential-group, dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of Tomivosertib (eFT-508). The study will evaluate oral daily administration of Tomivosertib (eFT-508). Treatment and study subject evaluation will be performed in 21-day cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Presence of an active hematological malignancy.
- •Presence of measurable disease.
- •Hematological malignancy has been previously treated, has relapsed after or progressed during prior therapy, and has limited potential for benefit from currently available therapy including hematopoietic stem cell transplantation.
- •At least 2 weeks post any treatments/therapies at the time of first dose.
- •Adequate bone marrow function.
- •Adequate hepatic function.
- •Adequate renal function.
- •Normal coagulation panel.
- •Negative antiviral serology.
- •Willingness to use effective contraception.
排除标准
- •Central nervous system malignancy
- •Gastrointestinal disease
- •Significant cardiovascular disease
- •Significant ECG abnormalities.
- •Ongoing risk for bleeding due to active peptic ulcer disease, bleeding diathesis or requirement for systemic anticoagulation
- •Ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections)
- •Pregnancy or breastfeeding.
- •Major surgery within 4 weeks before the start of study therapy.
- •Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids
- •Use of drugs that could prolong the QT interval within 7 days before the start of study therapy.
- •Use of drugs that might pose a risk of a drug-drug interaction within 2-7 days before the start of study therapy.
研究组 & 干预措施
Tomivosertib (eFT-508) Escalation Cohort
This portion of the study will evaluate the safety and pharmacology of a range of Tomivosertib (eFT-508) doses administered daily in subjects with previously treated lymphomas
干预措施: Tomivosertib (eFT-508) (Drug)
Tomivosertib (eFT-508) Expansion Cohort
This portion of the study provides cohort expansion to further explore the safety, pharmacology, and clinical activity of a single dose level of Tomivosertib (eFT-508) monotherapy in subjects with specific previously treated lymphomas
干预措施: Tomivosertib (eFT-508) (Drug)
结局指标
主要结局
Maximum Tolerated Dose and/or Recommended Dose within the tested Tomivosertib (eFT-508) dose range
时间窗: up to one year
Overall Response Rate
时间窗: up to three years
次要结局
未报告次要终点