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

Sponsor
Beijing InnoCare Pharma Tech Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04438044
Collaborator
(none)
39
Enrollment
5
Locations
1
Arm
42.4
Anticipated Duration (Months)
7.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 39 subjects. Pharmacokinetics of ICP-022 will be evaluated in approximately 20 subjects .

Study Design

Study Type:
Interventional
Anticipated Enrollment :
39 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 18, 2019
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: ICP-022

150mg,QD

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. The occurrence of adverse events and serious adverse events [every cycle, first cycle every week. Each cycle is 28 days]

    The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria

  2. 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]

  3. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Cancer Hospital Beijing Beijing China
2 Beijing Tiantan Hospital affiliated to Capital Medical University Beijing Beijing China
3 Capital Medical University Xuanwu Hospital Beijing Beijing China
4 Guangdong General Hospital Guangzhou Guangdong China
5 Huashan Hospital affiliated to Fudan University Shanghai Shanghai China

Sponsors and Collaborators

  • Beijing InnoCare Pharma Tech Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beijing InnoCare Pharma Tech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04438044
Other Study ID Numbers:
  • ICP-CL-00106
First Posted:
Jun 18, 2020
Last Update Posted:
Jul 29, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Beijing InnoCare Pharma Tech Co., Ltd.
Recurrent or refractory
Additional relevant MeSH terms:
Lymphoma
Neoplasm Metastasis

Study Results

No Results Posted as of Jul 29, 2021