EUCTR2014-002117-28-IT进行中（未招募）1 期
An Open-label, Phase 2 Study of ACP-196 in Subjectswith Mantle Cell Lymphoma - NA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 117
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
- •Men and women aged 18 years.
- •Pathologically confirmed MCL, with documentation of monoclonal B cells
- •die have a chromosomal translocation t (11; 14) (q13; q32) and / or one
- •overexpression of cyclin Dl.
- •Relapsing disease after, or refractory to, 1 previous therapy for [V1CL and now
- •requesting further treatment.
- •Failure to document at least one RP with the regime of
- •recent pki treatment or progression of the disease documented after the regimen
- •of more recent treatment.
- •Presence of lymphadenopathy or extranodal lymphoid malignancy
- •radiologically measurable (defined as the presence of 1 lesion that measures
- •2.0 cm in the longest dimension and 1.0 cm in the perpendicular dimension
- •long standing evaluated by computerized tomography [TC]).
- •At least 1, but no more than 5, previous treatment regimens for MCL. (Note: I
- •subjects who received 2 dcli of previous treatment with bortezomib or
- •any other commercially available proteasome inhibitor, either as an agent
- •in monotherapy or as part of a combination therapeutic regimen, they will come
- •considered exposed to proteasome inhibitor).
- •Status of validity according to the Eastern Group of Cooperative Oncology (Eastern
- •Cooperative Oncology Group, ECOG) <2.
- •Sexually active women who are able to conceive children must accept
- •use highly effective forms of contraception during the study and for 2 days
- •after the last dose of the study drug
- •This criterion is removed as per protocol version 8Volontà and possibility of
- •participate in all assessments and procedures required by this protocol
- •study, including the ability to swallow the capsules without difficulty.
- •Ability to understand the purpose and risks of the study and to provide a consensus
- •informed signed and dated and authorization to use health information
- •protected (in compliance with national and local regulations concerning the privacy of the
- •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 59
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 58
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 or corrected QT interval (QTc)> 480 msec.
- •4. Malabsorption syndrome, disease significantly affecting
- •gastrointestinal function, or resection of the stomach or small bowel, gastric bypass, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
- •5. Any immunotherapy within 4 weeks of first dose of study drug.
- •6. The time from the last dose of the most recent chemotherapy or experimental therapy to the first dose of study drug is < 5 times the half-life of the previously administered agent(s).
- •7. Prior exposure to a BCR inhibitor (eg, Btk, phosphoinositide- 3 kinase (PI3K), or Syk inhibitors) or BCL-2 inhibitor (eg, ABT-199).
- •8. Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids for treatment of MCL 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. Known 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 antagonist (eg, phenprocoumon) within 7 days of first dose
- •of study drug.
- •16. Requires treatment with proton pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, exlansoprazole, rabeprazole,or pantoprazole).
- •17. 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 ; and aspartate aminotransferase (AST) or alanine
- •aminotransferase (ALT) > 3.0 x ULN.
- •19. Breastfeeding or pregnant.
- •20. Concurrent participation in another therapeutic clinical trial.
- •21. Known central nervous system (CNS) lymphoma or leptomeningeal
- •22. Requires treatment with a strong CYP3A4 inhibitor/inducer.
- •23. Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3
研究者
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