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A Study of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia

NCT04440059 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2024-04-18

No results posted yet for this study

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.

Conditions

  • Waldenstrom's Macroglobulinemia Recurrent
  • Waldenstrom's Macroglobulinemia Refractory

Interventions

DRUG

ICP-022

ICP-022 at a dose of 150mg PO QD

Sponsors & Collaborators

  • Beijing InnoCare Pharma Tech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-10
Primary Completion
2024-01-09
Completion
2024-01-09

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04440059 on ClinicalTrials.gov