NCT03493217Unknown1 期
A Multicenter, Open-label Study to Evaluate the Safety and Efficacy of ICP-022 in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 100
- 试验地点
- 25
- 主要终点
- 1.Objective response rate (ORR)
研究概览
简要总结
The phase I/II clinical study is to investigate the safety, tolerability and efficacy of ICP-022 in R/R CLL/SLL patients.
详细描述
Part I: Safety evaluation -2 regimens of ICP-022 (High and low dose QD) are designed for safety assessment. The recommended dose of phase II clinical study will be determined according to the Part I results.
Part II: Dose expansion -Anti-tumor effects of ICP-022 in Chinese patients with R/R CLL/SLL will be evaluated in approximately 80 subjects. The recommended Phase 2 dose will be used in the Part II.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women with the age more than 18 years
- •Subjects with confirmed diagnosis of CLL/SLL following IWCLL2008 criteria
- •Refractory or relapsed CLL/SLL who have received at least one prior therapy
- •At least two measurable tumors of greater than 1.5 centimeter in long axis by contrast-enhanced CT/MRI
- •ECOG performance status of 0-2
- •Documented failure to achieve at least partial response (PR) or documented disease progression after response to, the most recent treatment regimen.There are medicalrecords confirming that the disease has not responded to the mostrecent treatment (complete and partial remission) or that thedisease has progressed after remission
- •Subjects who meet the following laboratory parameters:
- •Absolute neutrophil count (ANC) ≥ 0.75×109/L, Platelet count ≥ 50×109/L independent of growth factor support within 7 days of the first dose of study drug
- •Total bilirubin ≤ 2× ULN (unless due to Gilbert's syndrome); AST or ALT ≤ 2.5 ULN; Creatinine ≤ 1.5 ULN; Amylase ≤ 1.5 ULN
- •International normalized ratio (INR) ≤ 1.5 ULN and activated partial thromboplastin time (APTT) ≤ 1.5 ULN
- •Life expectancy ≥ 4 months
- •Able to provide signed written informed consent
排除标准
- •History of other active malignancies within 5 years of study entry, unless cured without evidence of relapse or metastasis
- •Current or history of lymphoma involved central nervous system
- •Any history of Richter's transformation
- •Prior corticosteroids (at dosages equivalent to prednisone > 20 mg/day) given with anti-neoplastic intent within 7 days, prior chemotherapy, targeted therapy, radiation therapy, or antibody based therapies or anti-cancer TCM within 4 weeks of the start of study drug.
- •Non-hematological toxicity must be recovered to ≤ Grade 1 from prior anti-cancer therapy (except alopecia)
- •Current Clinically significant cardiovascular disease including:
- •Any class 3 or 4 cardiac disease such as arrhythmia, congestive heart failure or myocardial infarction defined by the New York Heart Association Functional Classification, or left ventricular ejection fraction (LVEF) < 50%
- •Primary cardiomyopathy
- •Clinical significant QTc prolong history or QTc>470ms (female) QTc>450ms (male)
- •Uncontrolled hypertension
- •Subjects with active bleeding within 2 months of study start or currently taking anticoagulant/antiplatelet drugs
- •Urine protein ≥ 2+ and quantitation ≥ 2g/24hours
- •History of deep vein thrombosis or pulmonary embolism
- •Disease significantly affecting gastrointestinal function such as dysphagia, chronic diarrhea, intestinal obstruction, or resection of the stomach
- •Prior allogeneic stem cell transplant within 6 months prior to first dose of study drug or related active infection
- •Prior organ or allogeneic hematopoietic stem cell transplant within 6 months prior to first dose of study drug
- •Major surgery within 6 weeks of screening, except for diagnostic test or vascular access setup
- •Known active infection with HBV, HCV or HIV or any uncontrolled active systemic infection
- •Any history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe lung function impairment
- •Prior exposure to a BTK inhibitor or PI3K, SYK, bcl-2 inhibitors
- •History of stroke or intracranial hemorrhage within 6 months prior to enrollment
- •Any mental or cognitive disorder, unable to understand and comply with the requirements of the study
- •Drug abuser or alcoholics
- •Lactating or pregnant women, or women who will not agree to use contraception during the study and for 180 days after the last dose of study drug if sexually active and able to bear children
- •Requires treatment with moderate or strong cytochrome P450 family 3, subfamily A (CYP3A) inhibitors or strong CYP3A inducers.
研究组 & 干预措施
ICP-022
Experimental
Two regimens of ICP-022 (High and low dose QD) are designed for study Part I to determine RP2D. The RP2D determined will be used in Part II to further evaluate the preliminary efficacy of ICP-022 in Chinese subjects with R/R CLL/SLL.
干预措施: ICP-022 (Drug)
结局指标
主要结局
1.Objective response rate (ORR)
时间窗: Up to 3 years
The efficacy measured by overall response rate (ORR) in Part II. Efficacy was evaluated by researchers according to IWCLL2008standard and update standard (Hallek, 2012), which was defined as complete remission (CR) of CLLsubjects, complete remission with incomplete bone marrow recovery (CRi), or partial remission (PR),including nodular partial remission (nPR) and partial remission with lymphocytosis (pr-l).SLL subjectsachieved complete response (CR) or partial response (PR).
次要结局
- TTR(Up to 3 years)
- TTP(Up to 3 years)
- Occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria(Up to 3 years)
- PFS(Up to 3 years)
- DOR(Up to 3 years)
- OS(Up to 3 years)
研究者
研究点 (25)
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