A Phase 2 Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination with Ruxolitinib in Subjects with Myelofibrosis

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 164 人开始时间: 2017年6月27日最近更新: 2020年10月6日

适应症

试验速览

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•- Subjects = 18 years of age
•- Subjects with documented diagnosis of Intermediate or High-risk Primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential 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

•- 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.

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