NCT03797456
Completed
Phase 2
A Multicenter, Open-label Study to Evaluate the Safety and Efficacy of ICP-022 in Patients With Relapsed/Refractory Marginal Zone Lymphoma (MZL)
Overview
- Phase
- Phase 2
- Intervention
- ICP-022
- Conditions
- MZL
- Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Enrollment
- 111
- Locations
- 32
- Primary Endpoint
- Overall Response Rate (ORR)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The phase II clinical study is to investigate the safety, tolerability, efficacy and pharmacokinetics of ICP-022.
Safety, tolerability evaluation, and anti-tumor effects of ICP-022 in Chinese patients with R/R MZL will be evaluated in approximately 110 subjects. Pharmacokinetics of ICP-022 will be evaluated in approximately 20 subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men and women between 18 and 75 years old
- •Histologically confirmed marginal zone lymphoma (MZL), and at least one measurable tumor of greater than 1.5 centimeter outside of the spleen
- •Subjects with refractory or relapsed MZL who has received at least 1 but no more than 4 prior therapies for MZL
- •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 have indications for treatment (threatened end-organ function, bulky disease \>5cm, symptoms, steady progression, wish to treat)
- •Subjects meet the following laboratory parameters:
- •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 ≥ 75 g/L; ANC ≥ 1.0×109/L, Platelet count ≥ 50×109/L, Hemoglobin ≥ 50 g/L; if bone marrow involvement
- •Total bilirubin ≤ 1.5× ULN; AST or ALT ≤ 2× ULN; Creatinine ≤ 1.5× ULN; Amylase ≤ ULN and Lipase ≤ ULN
- •International normalized ratio (INR) ≤ 1.5 ULN
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 (except for 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
- •Known active bleeding within 2 months of screening or currently taking anticoagulant/antiplatelet drugs
Arms & Interventions
ICP-022
Intervention: ICP-022
Outcomes
Primary Outcomes
Overall Response Rate (ORR)
Time Frame: Up to 3 years
The efficacy measured by overall response rate (ORR) in Part II according to the 2014 International Working Group NHL
Secondary Outcomes
- Maximum plasma drug concentrations (Cmax)(up to 4 weeks)
- Duration of Response (DR)(Up to 3 years)
- Time of maximum plasma drug concentrations (Tmax)(up to 4 weeks)
- Progressioin free survival (PFS)(Up to 3 years)
- Area under the concentration time curve up to the time "t" (AUC(0-t))(up to 4 weeks)
- Area under the concentration time curve up to the last data point above LOQ (AUC(last))(up to 4 weeks)
- Overall survival (OS)(Up to 3 years)
- Occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria in Part I(Up to 3 years)
- Apparent half-life for designated elimination phases (t½)(up to 4 weeks)
Study Sites (32)
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