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

Beijing InnoCare Pharma Tech Co., Ltd.61 enrolled

Overview

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 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 .

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

PCNSL Secondary Central Nervous System Lymphoma

Interventions

ICP-022DRUG

ICP-022 The drug product is a white, round, uncoated tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: 1. Men and women ≥ 18, and ≤75 years of age 2. Histologically documented PCNSL, or histologically documented systemic diffuse large B-cell lymphoma (DLBCL) for SCNSL. 3. Subjects with refractory or relapsed disease, one prior CNS directed therapy, and ≤ 4 systemic treatments. 4. ECOG performance status of 0-2 5. Able to provide signed written informed consent Key Exclusion Criteria: 1. Patients with SCNSL actively receiving treatment for extra-CNS disease are excluded 2. T-cell lymphoma. 3. Patient requires more than 8 mg of dexamethasone daily or the equivalent. 4. Non-hematological toxicity must recover to ≤ Grade 1 from prior anti-cancer therapy (except for alopecia) 5. Known active infection with HBV, HCV or HIV. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (5)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing Tiantan Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Capital Medical University Xuanwu Hospital

Beijing, Beijing Municipality, China

Guangdong General Hospital

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

The efficacy measured by overall response rate (ORR)

Time frame: Cycle 1-6 once every 2 cycles; more than 6 cycles once every 3 cycles. Each cycle is 28 days

Secondary Outcomes

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

Time frame: every cycle, first cycle every week. Each cycle is 28 days

The efficacy measured by progression free survival (PFS)

Time frame: 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)

Time frame: cycle 1-6 once every 2 cycles; monre than 6 cycles once every 3 cycles. Each cycle is 28 days

Data from ClinicalTrials.gov

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