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

NCT ID: NCT04438044

Last Updated: 2022-10-12

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-18

Study Completion Date

2023-12-31

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 .

Conditions

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PCNSL Secondary Central Nervous System Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ICP-022

150mg,QD

Group Type EXPERIMENTAL

ICP-022

Intervention Type DRUG

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

Interventions

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ICP-022

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

Intervention Type DRUG

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing InnoCare Pharma Tech Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Huashan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status

Beijing Tiantan Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Capital Medical University Xuanwu Hospital

Beijing, Beijing Municipality, China

Site Status

Guangdong General Hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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ICP-CL-00106

Identifier Type: -

Identifier Source: org_study_id

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