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This is a multi-center, non-randomized and open-label phase I/IIa clinical study to evaluate the safety, tolerability, and efficacy of ICP-490 in patients with relapsed or refractory non-hodgkin lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICP-490 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICP-490 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, type, and severity of adverse events (AEs) as judged according to NCI-CTCAE V5.0 | Through study completion,an average of 3 years | |
| Incidence, type, and severity of dose-limiting toxicities (DLTs); | Through study completion,an average of 3 years | |
| Recommended Phase 2 Doses(RP2Ds) and/or maximum tolerated doses(MTDs). | Through study completion,an average of 3 years | |
| ORR assessed according to the Lugano criteria (Cheson 2014). | Through study completion,an average of 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters: maximum concentration (Cmax) | Through study completion,an average of 3 years | |
| PK parameters: time to maximum concentration (Tmax) | Through study completion,an average of 3 years | |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexia Lu | Contact | 010-66609745 | CO_HGRAC@innocarepharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Fuzhou | Fujian | 350014 | China |
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| PK parameters: half-life (T1/2) |
| Through study completion,an average of 3 years |
| PK parameters: area under the concentration-time curve (AUC0-∞ and AUC0-t) | Through study completion,an average of 3 years |
| PK parameters: apparent clearance (CL/F) | Through study completion,an average of 3 years |
| PK parameters: apparent volume of distribution during terminal phase (Vz/F) | Through study completion,an average of 3 years |
| PK parameters:Steady-state PK parameters | Through study completion,an average of 3 years |
| The overall response rate (ORR) assessed according to the Lugano criteria (Cheson 2014). | Through study completion,an average of 3 years |
| Complete response rate (CRR) assessed according to the Lugano criteria (Cheson 2014). | Through study completion,an average of 3 years |
| Time to response (TTR) assessed according to the Lugano criteria (Cheson 2014). | Through study completion,an average of 3 years |
| Duration of response (DOR) assessed according to the Lugano criteria (Cheson 2014). | Through study completion,an average of 3 years |
| Progression-free survival (PFS) assessed according to the Lugano criteria (Cheson 2014). | Through study completion,an average of 3 years |
| Overall survival (OS) | Through study completion,an average of 3 years |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510000 | China |
|
| Henan Cancer Hosptital | Zhengzhou | Henan | 450000 | China |
|
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330000 | China |
|
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin Municipality | 300000 | China |
|
| The Second Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | 650000 | China |
|
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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