A Study to Evaluate ICP-022 in Patients With R/R PCNSL and SCNSL

Study Overview
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Brief Summary
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The phase II clinical study is to investigate the safety, tolerability, efficacy and pharmacokinetics of ICP-022.

Detailed Description
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Safety, tolerability evaluation, and anti-tumor effects of ICP-022 in Chinese patients with Recurrent/Refractory Central Nervous System Lymphoma (PCNSL) and Recurrent/Refractory Secondary Central Nervous System Lymphoma (SCNSL) will be evaluated in approximately 82 subjects. Pharmacokinetics of ICP-022 will be evaluated in approximately 20 subjects .

Official Title
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A Phase II, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of ICP-022 in Patients With Recurrent/Refractory Central Nervous System Lymphoma and Recurrent/Refractory Secondary Central Nervous System Lymphoma

Conditions
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PCNSL, Secondary Central Nervous System Lymphoma

Intervention / Treatment
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* Drug: ICP-022


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Men and women ≥ 18, and ≤75 years of age Histologically documented PCNSL, or histologically documented systemic diffuse large B-cell lymphoma (DLBCL) for SCNSL. Subjects with refractory or relapsed disease, one prior CNS directed therapy, and ≤ 4 systemic treatments. ECOG performance status of 0-2 Able to provide signed written informed consent Key Exclusion Criteria: Patients with SCNSL actively receiving treatment for extra-CNS disease are excluded T-cell lymphoma. Patient requires more than 8 mg of dexamethasone daily or the equivalent. Non-hematological toxicity must recover to ≤ Grade 1 from prior anti-cancer therapy (except for alopecia) Known active infection with HBV, HCV or HIV. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICP-022<br>150mg,QD | Drug: ICP-022<br>* ICP-022 The drug product is a white, round, uncoated tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy measured by overall response rate (ORR) |  | Cycle 1-6 once every 2 cycles; more than 6 cycles once every 3 cycles. Each cycle is 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of adverse events and serious adverse events | The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria | every cycle, first cycle every week. Each cycle is 28 days | 
| The efficacy measured by progression free survival (PFS) |  | cycle 1-6 once every 2 cycles; more than 6 cycles once every 3 cycles. Each cycle is 28 days | 
| The efficacy measured by duration of response (DOR) |  | cycle 1-6 once every 2 cycles; monre than 6 cycles once every 3 cycles. Each cycle is 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent or refractory