Trials / Unknown
UnknownNCT03493217
A Study to Evaluate ICP-022 in Patients With CLL/ SLL
A Multicenter, Open-label Study to Evaluate the Safety and Efficacy of ICP-022 in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The phase I/II clinical study is to investigate the safety, tolerability and efficacy of ICP-022 in R/R CLL/SLL patients.
Detailed description
Part I: Safety evaluation -2 regimens of ICP-022 (High and low dose QD) are designed for safety assessment. 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 CLL/SLL 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
- 2018-04-17
- Primary completion
- 2022-12-31
- Completion
- 2022-12-31
- First posted
- 2018-04-10
- Last updated
- 2022-07-06
Locations
25 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03493217. Inclusion in this directory is not an endorsement.