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

Primary Purpose

PCNSL, Secondary Central Nervous System Lymphoma

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
ICP-022
Sponsored by
Beijing InnoCare Pharma Tech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PCNSL focused on measuring Recurrent or refractory

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Cancer Hospital
  • Beijing Tiantan Hospital affiliated to Capital Medical University
  • Capital Medical University Xuanwu Hospital
  • Guangdong General Hospital
  • Huashan Hospital affiliated to Fudan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ICP-022

Arm Description

150mg,QD

Outcomes

Primary Outcome Measures

The efficacy measured by overall response rate (ORR)

Secondary Outcome Measures

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
The efficacy measured by progression free survival (PFS)
The efficacy measured by duration of response (DOR)

Full Information

First Posted
June 16, 2020
Last Updated
October 10, 2022
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04438044
Brief Title
A Study to Evaluate ICP-022 in Patients With R/R PCNSL and SCNSL
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 18, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCNSL, Secondary Central Nervous System Lymphoma
Keywords
Recurrent or refractory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICP-022
Arm Type
Experimental
Arm Description
150mg,QD
Intervention Type
Drug
Intervention Name(s)
ICP-022
Intervention Description
ICP-022 The drug product is a white, round, uncoated tablet
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
The occurrence of adverse events and serious adverse events
Description
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Tiantan Hospital affiliated to Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Capital Medical University Xuanwu Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Huashan Hospital affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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