A Study to Evaluate ICP-022 in Patients With R/R Marginal Zone Lymphoma (MZL)
NCT03797456 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 111
Last updated 2024-04-18
Summary
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 R/R MZL will be evaluated in approximately 110 subjects. Pharmacokinetics of ICP-022 will be evaluated in approximately 20 subjects.
Conditions
Interventions
- DRUG
-
ICP-022
ICP-022 (tablets, 50 mg) is given orally at the dose of 150 mg/day from day 1 to day 28 of each cycle for up to a total of 6 cycles or until progression.
Sponsors & Collaborators
-
Beijing InnoCare Pharma Tech Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jun Zhu, PhD · Peking University Cancer Hospital & Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-04-01
- Primary Completion
- 2023-12-27
- Completion
- 2024-02-06
Countries
- China
Study Locations
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