A Multicenter, Open Clinical Trial to Evaluate the Safety and Efficacy of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia (WM)

Beijing InnoCare Pharma Tech Co., Ltd.16 sites in 1 country47 target enrollmentAugust 10, 2019

ConditionsWaldenstrom's Macroglobulinemia Recurrent Waldenstrom's Macroglobulinemia Refractory

InterventionsICP-022

DrugsICP-022

Overview

Phase: Phase 2
Intervention: ICP-022
Conditions: Waldenstrom's Macroglobulinemia Recurrent
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Enrollment: 47
Locations: 16
Primary Endpoint: Major response rate（MRR）
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 10, 2019

End Date

January 9, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Present or prior history of other malignant neoplasms, unless radical treatment has been performed and there is no evidence of recurrence or metastasis in the last 5 years
•Amyloidosis and central nervous system (CNS) involvement caused by WM
•Demonstrate disease transformation
•Patients who had received autologous stem cell transplantation within the previous 6 months
•A history of organ transplantation or allogeneic bone marrow transplantation
•NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Arms & Interventions

ICP-022

Subjects will take ICP-022 150mg once daily (QD).

Intervention: ICP-022

Outcomes

Primary Outcomes

Major response rate（MRR）

Time Frame: Up to 3 years

Secondary Outcomes

Progression Free Survival (PFS)(Evaluate during the screening period, 1-6 treatment cycle every 2 cycles (8 weeks), 6th-27th cycles every 3 cycles, evaluating every 6 cycles after the 27th cycle. Each cycle is 28 days.)
Duration of Major Mitigation (DOMR)(Evaluate during the screening period, 1-6 treatment cycle every 2 cycles (8 weeks), 6th-27th cycles every 3 cycles, evaluating every 6 cycles after the 27th cycle. Each cycle is 28 days.)
The occurrence of adverse events and serious adverse events(Cycle 1 (every 2 weeks), cycle 2-12 (every 4 weeks); After cycle 12 (every 12 weeks). Each cycle is 28 days.)