Trials / Completed
CompletedNCT03797456
A Study to Evaluate ICP-022 in Patients With R/R Marginal Zone Lymphoma (MZL)
A Multicenter, Open-label Study to Evaluate the Safety and Efficacy of ICP-022 in Patients With Relapsed/Refractory Marginal Zone Lymphoma (MZL)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 111 (actual)
- Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-04-01
- Primary completion
- 2023-12-27
- Completion
- 2024-02-06
- First posted
- 2019-01-09
- Last updated
- 2024-04-18
Locations
32 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03797456. Inclusion in this directory is not an endorsement.