A Study to Evaluate ICP-022 in Patients With R/R Mantle Cell Lymphoma (MCL)
NCT ID: NCT03494179
Last Updated: 2023-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
120 participants
INTERVENTIONAL
2018-04-02
2023-12-31
Brief Summary
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Detailed Description
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Part II: Dose expansion -Anti-tumor effects of ICP-022 in Chinese patients with R/R MCL will be evaluated in approximately 80 subjects. The recommended Phase 2 dose will be used in the Part II.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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High Dose of ICP-022
Two regimens of ICP-022 (High dose QD and low dose BID) are designed for study Part I to determine RP2D which will be used in Part II to further evaluate the preliminary anti-tumor effects of ICP-022 in Chinese subjects with R/R MCL.
ICP-022
The drug product is a white, round, uncoated tablet.
Low Dose of ICP-022
Two regimens of ICP-022 (High dose QD and low dose BID) are designed for study Part I to determine RP2D which will be used in Part II to further evaluate the preliminary anti-tumor effects of ICP-022 in Chinese subjects with R/R MCL.
ICP-022
The drug product is a white, round, uncoated tablet.
Interventions
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ICP-022
The drug product is a white, round, uncoated tablet.
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed mantle cell lymphoma (MCL), with either t(11;14) by cytogenetics and/or cyclin D1 overexpression by immunohistochemistry (IHC)
* Subjects with refractory or relapsed mantle cell lymphoma who has received at least 1 but no more than 4 prior therapies for MCL
* At least one measurable tumor 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.
* Subjects who meet the following laboratory parameters:
1. Absolute neutrophil count (ANC) ≥ 1.5×109/L Platelet count ≥ 75×109/L, independent of growth factor support within 7 days of the first dose with study drug, Hemoglobin ≥ 80 g/L; ANC ≥ 1.0×109/L, Platelet count ≥ 50×109/L if bone marrow involvement
2. Total bilirubin ≤ 2× ULN; AST or ALT ≤ 2.5 ULN; Creatinine clearance ≥ 30ml/min; Amylase ≤ ULN and Lipase ≤ ULN
3. 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
Exclusion Criteria
* Current or history of lymphoma involved central nervous system
* 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 recover to ≤ Grade 1 from prior anti-cancer therapy
* 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
* Known active bleeding within 2 months of screening 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
* Allogeneic stem cell transplant within 6 months prior to first dose of study drug or related active infection
* 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，BCR pathway ingibitor(such as PI3K, SYK) or BCL-2 kinase inhibitor
* Suitable and ready for allogeneic stem cell transplant
* Inability to comply with study procedures
* Drug abuser or alcoholics
* Lactating or pregnant women, or women who will not 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.
18 Years
75 Years
ALL
No
Sponsors
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Beijing InnoCare Pharma Tech Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jun Zhu, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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Anhui Province Cancer Hospital
Hefei, Anhui, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Henan Tumor Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Wuhan Union Hospital
Wuhan, Hubei, China
Tongji Hospital
Wuhan, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
The First Hospital of China Medical University
Shenyang, Liaojing, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
Qilu Hosptial of Shandong University
Jinan, Shandong, China
Shandong Provincial Hospital
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Xin Hua Hospital Affiated to Shanghai Jiao Tong University School of Medicin
Shanghai, Shanghai Municipality, China
West China Hospital,Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Zhengjiang University
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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References
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Deng LJ, Zhou KS, Liu LH, Zhang MZ, Li ZM, Ji CY, Xu W, Liu T, Xu B, Wang X, Gao SJ, Zhang HL, Hu Y, Li Y, Cheng Y, Yang HY, Cao JN, Zhu ZM, Hu JD, Zhang W, Jing HM, Ding KY, Zhang XY, Zhao RB, Zhang B, Tian YM, Song YP, Song YQ, Zhu J. Orelabrutinib for the treatment of relapsed or refractory MCL: a phase 1/2, open-label, multicenter, single-arm study. Blood Adv. 2023 Aug 22;7(16):4349-4357. doi: 10.1182/bloodadvances.2022009168.
Other Identifiers
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ICP-CL-00102
Identifier Type: -
Identifier Source: org_study_id
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