Trials / Completed
CompletedNCT04438005
A Study of ICP-022 in Patients With R/R DLBCL
A Multicenter, Open-Label Study to Investigate the Safety and Efficacy of ICP-022 in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma (DLBCL)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
It is a phase II, multicenter, open-label study is to evaluate the safety, efficacy and pharmacokinetics of a novel BTK inhibitor, ICP-022, in approximately 85 subjects with R/R DLBCL. There will be no control group in this study. Each subject will receive treatment orally every day in 28-day cycles. Each cycle starts immediately after the previously completed cycle without a break between cycles.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ICP-022 | ICP-022 is a white, round, uncoated tablet, 50 mg. It is administered 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
- 2020-05-07
- Primary completion
- 2021-11-05
- Completion
- 2021-12-13
- First posted
- 2020-06-18
- Last updated
- 2024-05-13
Locations
7 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04438005. Inclusion in this directory is not an endorsement.