Trials / Unknown
UnknownNCT03494179
A Study to Evaluate ICP-022 in Patients With R/R Mantle Cell Lymphoma (MCL)
A Multicenter, Open-label Study to Evaluate the Safety and Efficacy of ICP-022 in Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL)
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The phase I/II clinical study is to investigate the safety, tolerability and pharmacokinetics/ pharmacodynamics of ICP-022.
Detailed description
Part I: PK/PD and safety evaluation -Two regimens of ICP-022 (High dose QD and low dose BID) were designed for assessment of safety, as well as PK/PD profiles. The recommended dose of phase II clinical study will be determined according to the Part I results. Part II: Dose expansion -Anti-tumor effects of ICP-022 in Chinese patients with R/R MCL will be evaluated in approximately 80 subjects. The recommended Phase 2 dose will be used in the Part II.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ICP-022 | The drug product is a white, round, uncoated tablet. |
Timeline
- Start date
- 2018-04-02
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
- First posted
- 2018-04-11
- Last updated
- 2023-06-05
Locations
31 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03494179. Inclusion in this directory is not an endorsement.