Trials / Unknown
UnknownNCT04438044
A Study to Evaluate ICP-022 in Patients With R/R PCNSL and SCNSL
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
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 61 (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.
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 .
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ICP-022 | ICP-022 The drug product is a white, round, uncoated tablet |
Timeline
- Start date
- 2019-06-18
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
- First posted
- 2020-06-18
- Last updated
- 2022-10-12
Locations
5 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04438044. Inclusion in this directory is not an endorsement.