JPRN-jRCT2080224824已完成1 期
A Phase 1 Open-Label Study Evaluating the Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination with Ruxolitinib in Myeloproliferative Neoplasm Subjects[M19-753]
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AbbVie GK
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Navitoclax Monotherapy (Part 1):
- •- Documented diagnosis of myelofibrosis (MF), polycythemia vera (PV) or essential thrombocythemia (ET) as defined by the World Health Organization classification.
- •- MF subjects must have received and failed or are intolerant to ruxolitinib therapy.
- •- ET or PV subjects must be requiring cytoreduction who have failed or are intolerant to at least one prior therapy, or who refuse standard therapy.
- •Navitoclax + ruxolitinib Combination Therapy (Part 2):
- •- Has documented diagnosis of primary MF, post-polycythemia vera MF (PPV-MF), or post-essential thrombocythemia (PET-MF) as defined by the World Health Organization classification.
- •- Is ineligible or unwilling to undergo stem cell transplantation at time of study entry.
- •- Has splenomegaly as defined by a spleen palpable >= 5 cm below costal margin or spleen volume >= 450 cm^3 as assessed by magnetic resonance imaging (MRI) or computed topography (CT) scan.
- •- Must have received ruxolitinib therapy for at least 12 weeks and be currently on a stable dose (as described in the protocol).
- •- Must have adequate bone marrow, kidney, liver and hematology blood values as detailed in the study protocol.
- •- Part 1 only: Cytoreduction therapy within 14 days prior to the first dose of navitoclax may be allowed pending additional discussion with study doctor. Ruxolitinib for MF subjects will not be allowed within 7 days prior to the first dose of study drug and during navitoclax administration.
排除标准
- •- Shows leukemic transformation (> 10% blasts in peripheral blood or bone marrow biopsy).
- •- Has a history of an active malignancy other than MPN within the past 2 years prior to study entry (exceptions detailed in the protocol).
- •- Has a positive test result for HIV at screening.
- •- Has chronic active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection requiring treatment.
- •- Has evidence of other clinically significant uncontrolled condition(s).
- •- Has previously taken a BH3 mimetic compound.
- •- Currently on medications that interfere with coagulation or platelet function with the exception of low dose aspirin (up to 100 mg) and low-molecular-weight heparin.
- •- Has received strong or moderate CYP3A inhibitors (e.g., ketoconazole, clarithromycin) within 14 days prior to the administration of the first dose of navitoclax.
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