EUCTR2014-003212-36-ES进行中（未招募）不适用
An Open-label, Phase 1b/2 Study of ACP-196 in Subjectswith Waldenström Macroglobulinemia - ACE-WM-001
适应症
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 ? 2.
- •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 agent(s).
- •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 disease).
- •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
相似试验
进行中（未招募）
1 期
A trial to see the effects of ACP-196 (the test drug) in Patients who have Waldenstrom MacroglobulinemiaWaldenström MacroglobulinemiaMedDRA version: 21.0Level: PTClassification code 10047804Term: Waldenstrom's macroglobulinaemia recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10047805Term: Waldenstrom's macroglobulinaemia refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-003212-36-NLAcerta Pharma BV88
进行中（未招募）
不适用
A Trial to See the Effects of ACP-196 (the test drug) in Patients who haveWaldenström MacroglobulinemiaEUCTR2014-003212-36-FRAcerta Pharma BV88
已完成
2 期
An Open-label, Phase 2 Study of ACP-196 in Subjects with Waldenström MacroglobulinemiaWaldenström Macroglobulinemiamobus Waldenström10025320NL-OMON53142ACERTA PHARMA, BV7
进行中（未招募）
1 期
A Trial to See the Effects of ACP-196 (the test drug) in Patients who have Mantle Cell LymphomaMedDRA version: 20.0Level: HLTClassification code 10026798Term: Mantle cell lymphomasSystem Organ Class: 100000004851Mantle Cell LymphomaEUCTR2014-002117-28-NLAcerta Pharma BV117
进行中（未招募）
1 期
A Trial to See the Effects of ACP-196 (the test drug) in Patients who have Mantle Cell LymphomaMedDRA version: 20.0Level: HLTClassification code 10026798Term: Mantle cell lymphomasSystem Organ Class: 100000004851Mantle Cell LymphomaEUCTR2014-002117-28-GBAcerta Pharma B.V.117