drugset / Trial / NCT04440059
A Study of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia
NaSingle-groupOpen-labelTreatment
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 WM will be evaluated in approximately 44 subjects. Pharmacokinetics of ICP-022 will be evaluated in approximately 20 subjects.
Timeline
- Start
- 2019-08-10
- Primary completion
- 2024-01-09
- Completion
- 2024-01-09
Publications
- Alfaifi A, Bahashwan S, Alsaadi M, Ageel AH, Ahmed HH, Fatima K, Malhan H, Qadri I, Almehdar H. Advancements in B-Cell Non-Hodgkin's Lymphoma: From Signaling Pathways to Targeted Therapies. Adv Hematol. 2024 Nov 12;2024:5948170. doi: 10.1155/2024/5948170. eCollection 2024.
- Cao XX, Jin J, Fu CC, Yi SH, Zhao WL, Sun ZM, Yang W, Li DJ, Cui GH, Hu JD, Liu T, Song YP, Xu B, Zhu ZM, Xu W, Zhang MZ, Tian YM, Zhang B, Zhao RB, Zhou DB. Evaluation of orelabrutinib monotherapy in patients with relapsed or refractory Waldenstrom's macroglobulinemia in a single-arm, multicenter, open-label, phase 2 study. EClinicalMedicine. 2022 Oct 4;52:101682. doi: 10.1016/j.eclinm.2022.101682. eCollection 2022 Oct.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Orelabrutinib | Small molecule | 150 mg | Oral |