EUCTR2014-003212-36-FR进行中（未招募）不适用
An Open-label, Phase 1b/2 Study of ACP-196 in Subjectswith Waldenström Macroglobulinemia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 88
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
- •1. Men and women = 18 years of age.
- •2. Previously treated cohort only: A confirmed diagnosis of WM, which
- •has relapsed after, or been refractory to = 1 prior therapy for WM and
- •which requires treatment
- •3. Previously untreated cohort only: A confirmed diagnosis of previously
- •untreated WM in subjects who require treatment and do not want to
- •receive chemoimmunotherapy or have comorbidities that would preclude chemoimmunotherapy such as:
- •Symptomatic hyperviscosity with an IgM = 5,000 mg/dL
- •Disease-related neuropathy
- •4. Serum concentration of IgM, as measured by serum protein
- •electrophoresis (SPEP) and immunofixation electrophoresis (IFE), that
- •exceeds the upper limits of normal or measurable nodal WM (defined as
- •the presence of =1 lymph node that measures = 2.0 cm in the longest
- •diameter and = 1.0 cm in the longest perpendicular diameter).
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of =
- •6. Agreement to use acceptable methods of contraception during the
- •study and for 30 days after the last dose of study drug if sexually active
- •and able to bear or beget children.
- •7. Agreement to refrain from sperm donation during the study and for 30 days after the last dose of study drug.
- •8. Willing and able to participate in all required evaluations and
- •procedures in this study protocol including swallowing capsules without
- •difficulty.
- •9. Ability to understand the purpose and risks of the study and provide
- •signed and dated informed consent and authorization to use protected
- •health information (in accordance with national and local subject privacy regulations).
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •1. Prior malignancy, except for adequately treated basal cell or
- •squamous cell skin cancer, in situ cervical cancer, or other cancer from
- •which the subject has been disease free for = 2 years or which will not
- •limit survival to < 2 years. Note: these cases must be discussed with the
- •Medical Monitor.
- •2. A life-threatening illness, medical condition or organ system
- •dysfunction which, in the investigator's opinion, could compromise the
- •subject's safety, interfere with the absorption or metabolism of ACP-196, or put the study outcomes at undue risk.
- •3. Significant cardiovascular disease such as uncontrolled or
- •symptomatic arrhythmias, congestive heart failure, or myocardial
- •infarction within 6 months of screening, or any Class 3 or 4 cardiac
- •disease as defined by the New York Heart Association Functional
- •Classification, or left ventricular ejection fraction (LVEF) = 40%, or QTc
- •> 480 msec.
- •4. Malabsorption syndrome, disease significantly affecting
- •gastrointestinal function, or resection of the stomach or small bowel or
- •ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
- •5. Any immunotherapy within 4 weeks of first dose of study drug.
- •6. For subjects with recent chemotherapy or experimental therapy the
- •first dose of study drug must occur after 5 times the half-life of the
- •7. Prior exposure to a BCR inhibitor (eg, Btk, phosphoinositide-3 kinase
- •[PI3K]]], or Syk inhibitors) or BCL-2 inhibitors (eg, ABT-199).
- •8. Ongoing immunosuppressive therapy, including systemic or enteric
- •corticosteroids for treatment of WM or other conditions. Note: Subjects
- •may use topical or inhaled corticosteroids or low-dose steroids (= 10 mg
- •of prednisone or equivalent per day) as therapy for comorbid conditions. During study participation, subjects may also receive systemic or enteric corticosteroids as needed for treatment-emergent comorbid conditions.
- •9. Grade = 2 toxicity (other than alopecia) continuing from prior
- •anticancer therapy including radiation.
- •10. Known history of human immunodeficiency virus (HIV) or active
- •infection with hepatitis C virus (HCV) or hepatitis B virus (HBV) or any
- •uncontrolled active systemic infection.
- •11. Major surgery within 4 weeks before first dose of study drug.
- •12. Uncontrolled autoimmune hemolytic anemia or idiopathic
- •thrombocytopenia purpura.
- •13. History of a bleeding diathesis (eg, hemophilia, von Willebrand
- •14. History of stroke or intracranial hemorrhage within 6 months before
- •the first dose of study drug.
- •15. Requires or receiving anticoagulation with warfarin or equivalent
- •vitamin K antagonists (eg, phenprocoumon) within 28 days of first dose
- •of study drug.
- •16. Requires treatment with long-acting proton pump inhibitors (eg,
- •omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole).
- •17. Absolute neutrophil count (ANC) < 0.75 x 109/L or platelet count
- •<50 x 109/L. For subjects with disease involvement in the bone marrow,
- •ANC < 0.50 x 109/L or platelet count < 30 x 109/L.
- •18. Creatinine > 2.5 x institutional upper limit of normal (ULN); total
- •bilirubin > 2.5 x ULN; or aspartate aminotransferase (AST) or alanine
- •aminotransferase (ALT) > 3.0 x ULN
- •19. Lactating or pregnant.
- •20. Concurrent participation in another therapeutic clinical trial.
研究者
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