EUCTR2010-022939-11-DE进行中（未招募）不适用
Multicenter phase 2 study of Bruton’s tyrosine kinase (Btk) inhibitor, PCI-32765, in relapsed or refractory mantle cell lymphoma
Pharmacyclics, Incorporated0 个研究点目标入组 115 人开始时间: 2011年4月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 115
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. Eastern Cooperative Oncology Group (ECOG) performance status of = 2
- •3. Pathologically confirmed MCL, with documentation of either overexpression of cyclin D1 or t(11;14), and measurable disease on cross sectional imaging that is = 2 cm in the longest diameter and measurable in 2 perpendicular dimensions per CT
- •4. Documented failure to achieve at least PR with, or documented disease progression after, the most recent treatment regimen
- •5. At least 1, but no more than 5, prior treatment regimens for MCL. (Note: Subjects having received =2 cycles of prior treatment with bortezomib, either as a single agent or as part of a combination therapy regimen, will be considered to be bortezomib-exposed.)
- •6. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
- •7. 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: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Prior chemotherapy within 3 weeks, nitrosoureas within 6 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy within 3 weeks, or major surgery within 2 weeks of first dose of study drug
- •2. Concurrent enrollment in another therapeutic investigational clinical study or have previously taken PCI-32765.
- •3. History of other malignancies within the past year except for treated basal cell or squamous cell skin cancer or in situ cervical cancer
- •4. Known central nervous system (CNS) lymphoma
- •5. Any 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 PCI-32765 capsules, or put the study outcomes at undue risk
- •6. Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
- •7. Significant screening electrocardiogram (ECG) abnormalities including left bundle branch block, 2nd degree AV block type II, 3rd degree block, bradycardia, or QTc = 500 msec
- •8. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or symptomatic ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction
- •9. 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
- •10. Lactating or pregnant
- •11. Will not agree to use highly effective contraception (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the study and for 30 days after the last dose of study drug (Note: applies to men and women of child-bearing potential only)
- •12. Any of the following laboratory abnormalities:
- •a. Absolute neutrophil count (ANC) < 750 cells/mm3 (0.75 x 10 9/L) unless there is documented bone marrow involvement
- •b. Platelet count < 50,000 cells/mm3 (50 x 10 9/L) independent of transfusion support unless there is documented bone marrow involvement
- •c. Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) = 3.0 x upper limit of normal (ULN)
- •d. Creatinine > 2.0 x ULN
研究者
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