Waldenstrom's Macroglobulinemia Recurrent, Waldenstrom's Macroglobulinemia Refractory
Conditions
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.
Interventions
DRUGICP-022
ICP-022 at a dose of 150mg PO QD
Sponsors
Beijing InnoCare Pharma Tech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major response rate（MRR） | Up to 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria |
| 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. | — |
Countries
China
Outcome results
None listed