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

Study Overview
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Brief Summary
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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.

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

Conditions
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Waldenstrom's Macroglobulinemia Recurrent, Waldenstrom's Macroglobulinemia Refractory

Intervention / Treatment
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* Drug: ICP-022


Participation Criteria
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Eligibility Criteria
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Key Inclusion criteria: Clinical and histologically confirmed giant globulinemia Fahrenheit (WM Ii International Working Group Standards, IWWM-2, 2003) (Owen et al., 2003) At least one treatment indication is met (7th WM International Working Group standards, IWWM-7) (Dimopoulos et al., 2014) With the lowest serum IgM value >2 times ULN as the efficacy evaluation index ECOG physical strength score 0-2 Voluntary written informed consent prior to trial screening. Key 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICP-022<br>Subjects will take ICP-022 150mg once daily (QD). | Drug: ICP-022<br>* ICP-022 at a dose of 150mg PO QD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major response rate（MRR） |  | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of adverse events and serious adverse events | The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria | Cycle 1 (every 2 weeks), cycle 2-12 (every 4 weeks); After cycle 12 (every 12 weeks). 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. | 
| 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. |