NCT04438044
Active, not recruiting
Phase 2
A Phase II, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of ICP-022 in Patients With Recurrent/Refractory Central Nervous System Lymphoma and Recurrent/Refractory Secondary Central Nervous System Lymphoma
Overview
- Phase
- Phase 2
- Intervention
- ICP-022
- Conditions
- PCNSL
- Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Enrollment
- 61
- Locations
- 5
- Primary Endpoint
- The efficacy measured by overall response rate (ORR)
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
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 .
Investigators
Eligibility Criteria
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
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.
Arms & Interventions
ICP-022
150mg,QD
Intervention: ICP-022
Outcomes
Primary Outcomes
The efficacy measured by overall response rate (ORR)
Time Frame: Cycle 1-6 once every 2 cycles; more than 6 cycles once every 3 cycles. Each cycle is 28 days
Secondary Outcomes
- 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)
- 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 occurrence of adverse events and serious adverse events(every cycle, first cycle every week. Each cycle is 28 days)
Study Sites (5)
Loading locations...
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