PCNSL, Secondary Central Nervous System Lymphoma
Conditions
Keywords
Recurrent or refractory
Brief summary
The phase II clinical study is to investigate the safety, tolerability, efficacy and pharmacokinetics of ICP-022.
Detailed description
Safety, tolerability evaluation, and anti-tumor effects of ICP-022 in Chinese patients with Recurrent/Refractory Central Nervous System Lymphoma (PCNSL) and Recurrent/Refractory Secondary Central Nervous System Lymphoma (SCNSL) will be evaluated in approximately 82 subjects. Pharmacokinetics of ICP-022 will be evaluated in approximately 20 subjects .
Interventions
DRUGICP-022
ICP-022 The drug product is a white, round, uncoated tablet
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 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Men and women ≥ 18, and ≤75 years of age 2. Histologically documented PCNSL, or histologically documented systemic diffuse large B-cell lymphoma (DLBCL) for SCNSL. 3. Subjects with refractory or relapsed disease, one prior CNS directed therapy, and ≤ 4 systemic treatments. 4. ECOG performance status of 0-2 5. Able to provide signed written informed consent Key
Exclusion criteria
1. Patients with SCNSL actively receiving treatment for extra-CNS disease are excluded 2. T-cell lymphoma. 3. Patient requires more than 8 mg of dexamethasone daily or the equivalent. 4. Non-hematological toxicity must recover to ≤ Grade 1 from prior anti-cancer therapy (except for alopecia) 5. Known active infection with HBV, HCV or HIV. Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy measured by overall response rate (ORR) | Cycle 1-6 once every 2 cycles; more than 6 cycles once every 3 cycles. Each cycle is 28 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The occurrence of adverse events and serious adverse events | every cycle, first cycle every week. 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 |
| The efficacy measured by progression free survival (PFS) | cycle 1-6 once every 2 cycles; more than 6 cycles once every 3 cycles. Each cycle is 28 days | — |
| The efficacy measured by duration of response (DOR) | cycle 1-6 once every 2 cycles; monre than 6 cycles once every 3 cycles. Each cycle is 28 days | — |
Countries
China
Outcome results
None listed