NCT01905813已完成1 期
A Phase 1, Open-label, Dose Escalation, Safety and Tolerability Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 5
- 主要终点
- Safety and tolerability of INCB040093 as monotherapy and when given in combination with itacitinib as determined by clinical laboratory assessments, physical exams, 12-lead ECG and summary of adverse events
研究概览
简要总结
The study will be conducted in three parts. Part 1 is a dose escalation phase to determine the maximum tolerated dose (MTD) of INCB040093, a PI3Kδ inhibitor, or a tolerated, pharmacologically active dose; Part 2 will evaluate the combination of INCB040093 and itacitinib (INCB039110), a JAK1 inhibitor, to determine the MTD of the combination or a tolerated dose that produces substantial pharmacologic inhibition of both targets; Part 3 will further evaluate the chosen doses of INCB040093 alone and in combination with itacitinib (INCB039110) in subjects with relapsed/refractory B-cell malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Aged 18 years or older, with lymphoid malignancies of B-cell origin as follows:
- •*Indolent / aggressive B-cell (NHL) Non- Hodgkin's Lymphoma:
- •EXCLUDING: Burkitt lymphoma and precursor B-lymphoblastic leukemia/lymphoma
- •INCLUDING: any non-Hodgkin's B-cell malignancy such as CLL and rare non-Hodgkin's B-cell subtypes such as Hairy Cell Leukemia, Waldenstrom macroglobulinemia, Mantle cell lymphoma, transformed NHL histologies, etc.
- •*Hodgkin's lymphoma
- •Life expectancy of 12 weeks or longer.
- •Subject must have received ≥ 1 prior treatment regimen.
- •The subject must not be a candidate for potentially curative therapy, including stem cell transplant.
排除标准
- •Received an investigational study drug within 28 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study drug.
- •Received any approved anticancer medications within 21 days or 5 half-lives (whichever is longer) prior to receiving their first dose of study drug (42 days for nitrosoureas) EXCEPT steroids at ≤ 10 mg prednisone daily (or equivalent).
- •Has any unresolved toxicity ≥ Grade 2 from previous anticancer therapy.
- •Has history of brain metastases or spinal cord compression, or lymphoma involving the central nervous system.
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status of ≥
- •Received allogeneic hematopoietic stem cell transplant within the last 6 months, or has active graft versus host disease (GVHD) following allogeneic transplant, or is currently receiving immunosuppressive therapy following allogeneic transplant.
- •Received autologous hematopoietic stem cell transplant within the last 3 months.
- •Laboratory parameters not within the protocol-defined range.
- •Current or recent history (<30 days prior to screening and/or <45 days prior to dosing) of a clinically meaningful bacterial, fungal, parasitic or mycobacterial infection.
- •Current clinically active viral infection.
- •Known history of infection with the human immunodeficiency virus (HIV).
- •History of active hepatitis or positive serology for hepatitis.
研究组 & 干预措施
INCB040093
Experimental
干预措施: INCB040093 (Drug)
INCB040093 in combination with itacitinib (INCB039110)
Experimental
干预措施: INCB040093 + itacitinib (Drug)
结局指标
主要结局
Safety and tolerability of INCB040093 as monotherapy and when given in combination with itacitinib as determined by clinical laboratory assessments, physical exams, 12-lead ECG and summary of adverse events
时间窗: Measured every 3 weeks until progression.
次要结局
- Preliminary efficacy as assessed by Overall Response Rate (ORR) as measured by published criteria for Hodgkin's/non-Hodgkin's lymphoma (Cheson et al 2007 and Owen et al 2013) and Chronic Lymphocytic Leukemia (CLL) (Cheson et el 2012)(Every 12 weeks (4 cycles) until study withdrawal)
- Pharmacokinetic (PK) collections.(Measured for each patient at Cycle 1 Day 1, Cycle 1 Day 8 and Cycle 1 Day 15)
研究者
研究点 (5)
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