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The phase I/II clinical study is to investigate the safety, tolerability and pharmacokinetics/ pharmacodynamics of ICP-022.
Full description
Part I: PK/PD and safety evaluation -Two regimens of ICP-022 (High dose QD and low dose BID) were designed for assessment of safety, as well as PK/PD profiles. 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 MCL will be evaluated in approximately 80 subjects. The recommended Phase 2 dose will be used in the Part II.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Men and women between 18 and 75 years old
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:
Life expectancy ≥ 4 months
Able to provide signed written informed consent
Exclusion criteria
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
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:
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.
Primary purpose
Allocation
Interventional model
Masking
120 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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