EUCTR2015-003386-28-FR进行中（未招募）1 期
A phase Ib/II multi-arm study with venetoclax in combination with cobimetinib, and venetoclax in combination with idasanutlin in patients = 60 years with relapsed or refractory acute myeloid leukemia who are not eligible for cytotoxic therapy
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
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
- •- Age >= 60 years
- •- Histological confirmation of relapsed or refractory AML after prior anti-leukemic therapy by WHO Classification
- •- Not eligible for cytotoxic therapies
- •- Ineligible for allogeneic stem cell transplant
- •- Life expectancy of at least 12 weeks
- •- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2
- •- Adequate liver and renal function
- •- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods
- •- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •- Patients with acute promyelocytic leukemia (French-American-British [FAB] class M3 AML)
- •- Known active central nervous system (CNS) involvement with AML at study entry
- •- Prior exposure to Bcl-2 inhibitors, murine double minute 2 (MDM2) antagonists or prior exposure to experimental treatment targeting Raf, mitogen-activated protein kinase (MEK), or the mitogen-activated protein kinase (MAPK) RAS/RAF/MEK/ERK MAPK pathway
- •- Positive for hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg) and known history of HIV, malignancy, active infection and cardiovascular diseases (CVs)
- •- Received strong cytochrome (CYP) 3A inhibitors, moderate CYP3A inhibitors, strong CYP3A inducers and moderate CYP3A inducers within 7 days prior to initiation of study treatment
- •- History of symptomatic Clostridium difficile infection within 1 month prior to dosing
- •Additional phase specific exclusion criteria:
- •Phase Ib Dose Escalation Arm A (Venetoclax and Cobimetinib)
- •- History or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment/central serous chorioretinopathy (CSCR), retinal vein occlusion (RVO), or neovascular macular degeneration
- •- Left ventricular ejection fraction (LVEF) below institutional lower limit of normal (LLN) or below 50%, whichever is lower
- •Phase Ib Dose-Escalation Arm B (Venetoclax and Idasanutlin):
- •Received the following within 7 days prior to the initiation of study treatment:
- •Strong CYP2C8 inhibitors or CYP2C8 substrates
- •OATP1B1/3 substrates
- •Received the following within 14 days prior to the initiation of study treatment:
- •Strong CYP2C8 inducers
- •- Received hormonal therapy (apart from luteinizing hormone releasing hormone agonist/antagonist for prostate cancer and hormone replacement therapy) within 2 weeks prior to the first dose of study treatment
- •- History of liver cirrhosis by radiologic, clinical or laboratory data, or biopsy despite normal liver function tests
- •Phase II Expansion Arm A and Arm B:
- •- Received the following within 7 days prior to the initiation of study treatment:
- •Strong CYP2C8 inhibitors or CYP2C8 substrates
- •OATP1B1/3 substrates
- •- Received the following within 14 days prior to the initiation of study treatment:
- •Strong CYP2C8 inducers
- •- History or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment/CSCR, RVO, or neovascular macular degeneration
- •- LVEF below institutional LLN or below 50%, whichever is lower
- •- Received hormonal therapy (apart from luteinizing hormone releasing hormone agonist/antagonist for prostate cancer and hormone replacement therapy) within 2 weeks prior to the first dose of study treatment
- •- History of liver cirrhosis by radiologic, clinical or laboratory data, or biopsy despite normal liver function tests
研究者
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