EUCTR2017-001398-17-IT进行中（未招募）1 期
A Phase 2 Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination with Ruxolitinib in Subjects with Myelofibrosis - na
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 164
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Subjects = 18 years of age
- •- Subjects with documented diagnosis of Intermediate or High-risk
- •Primary myelofibrosis, post-polycythemia vera myelofibrosis or postessential
- •thrombocythemia myelofibrosis
- •- Subjects classified as intermediate-2 or high-risk myelofibrosis, as
- •defined by the Dynamic International Prognostic Scoring System
- •- Subject must be ineligible or unwilling to undergo stem cell
- •transplantation at time of study entry
- •- Subject must have either received prior treatment with ruxolitinib OR
- •another JAK-2 inhibitor therapy OR must not have received any prior treatment with JAK-2 inhibitor or BET inhibitor.
- •- Subject has palpable splenomegaly.
- •- Subject must meet the laboratory parameters (adequate bone marrow,
- •renal and hepatic function) as defined in the protocol.
- •- Cohorts 1b and 3 only: Subject has at least 2 symptoms each with a
- •score = 3 or a total score of = 12, as measured by the MFSAF v4.0.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •- Splenic irradiation within 6 months prior to screening, or prior
- •splenectomy.
- •- Leukemic transformation (> 10% blasts in peripheral blood or bone
- •marrow biopsy).
- •- Subject is currently on medications that interfere with coagulation
- •(including warfarin) or platelet function with the exception of low dose
- •aspirin (up to 100 mg) and Low-molecular-weight heparin.
- •- Prior therapy with a BH3 mimetic compound.
- •- Cohort 1b only: Subject has received strong or moderate CYP3A
- •inhibitors within 14 days prior to the administration of the first dose of
- •navitoclax.
研究者
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