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

Beijing InnoCare Pharma Tech Co., Ltd.47 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Waldenstrom's Macroglobulinemia Recurrent Waldenstrom's Macroglobulinemia Refractory

Interventions

ICP-022DRUG

ICP-022 at a dose of 150mg PO QD

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (16)

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

Hefei, Anhui, China

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Major response rate（MRR）

Time frame: Up to 3 years

Secondary Outcomes

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

Time frame: 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)

Time frame: 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)

Time frame: 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.

Data from ClinicalTrials.gov

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