Brief Title
A Study of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia
Official Title
A Multicenter, Open Clinical Trial to Evaluate the Safety and Efficacy of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia (WM)
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Major response rate（MRR）
Secondary Outcome
The occurrence of adverse events and serious adverse events
Condition
Waldenstrom's Macroglobulinemia Recurrent
Intervention
ICP-022
Study Arms / Comparison Groups
ICP-022
Description: Subjects will take ICP-022 150mg once daily (QD).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
47
Start Date
July 11, 2019
Completion Date
December 31, 2023
Primary Completion Date
December 31, 2023
Eligibility Criteria
Key Inclusion criteria:
1. Clinical and histologically confirmed giant globulinemia Fahrenheit (WM Ii
International Working Group Standards, IWWM-2, 2003) (Owen et al., 2003)
2. At least one treatment indication is met (7th WM International Working Group
standards, IWWM-7) (Dimopoulos et al., 2014)
3. With the lowest serum IgM value >2 times ULN as the efficacy evaluation index
4. ECOG physical strength score 0-2
5. Voluntary written informed consent prior to trial screening.
Key Exclusion Criteria:
1. 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
2. Amyloidosis and central nervous system (CNS) involvement caused by WM
3. Demonstrate disease transformation
4. Patients who had received autologous stem cell transplantation within the previous 6
months
5. A history of organ transplantation or allogeneic bone marrow transplantation
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04440059
Organization ID
ICP-CL-00105
Responsible Party
Sponsor
Study Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Study Sponsor
, ,
Verification Date
October 2022