Overview
The phase II clinical study is to investigate the safety, tolerability, efficacy and pharmacokinetics of ICP-022.
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 39 subjects. Pharmacokinetics of ICP-022 will be evaluated in approximately 20 subjects .
Eligibility
Key Inclusion Criteria:
- Men and women 18, and 75 years of age
- Histologically documented PCNSL, or histologically documented systemic diffuse large B-cell lymphoma (DLBCL) for SCNSL.
- Subjects with refractory or relapsed disease, one prior CNS directed therapy, and 4 systemic treatments.
- ECOG performance status of 0-2
- Able to provide signed written informed consent
Key Exclusion Criteria:
- Patients with SCNSL actively receiving treatment for extra-CNS disease are excluded
- T-cell lymphoma.
- Patient requires more than 8 mg of dexamethasone daily or the equivalent.
- Non-hematological toxicity must recover to Grade 1 from prior anti-cancer therapy (except for alopecia)
- Known active infection with HBV, HCV or HIV.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.