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This is a randomized, controlled, open-label, multicenter, Phase III clinical study designed to compare the efficacy and safety of SYHA1813 versus treatment of investigators' choice in patients with recurrent or progressive high-grade meningioma not amenable to local therapy.
Approximately136 participants with recurrent or progressive high-grade meningioma who have received surgical resection and radiotherapy will be enrolled and randomized 1:1 to receive either SYHA1813 (experimental group) or investigators' choice (control group) treatment. The primary endpoint is progression-free survival (PFS) assessed by blinded Independent Review Committee (BIRC) using the Response Assessment in Neuro-Oncology Working Group (RANO criteria) for meningioma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | SYHA1813 |
|
| Control group | Active Comparator | Investigator's Choice Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYHA1813 | Drug | SYHA1813 20mg QD |
| |
| Investigator's Choice Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) as Assessed by RANO Criteria and Evaluated by BIRC | Up to approximately 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| PFS as Assessed by RANO Criteria and Evaluated by investigators | Up to approximately 4 years | |
| Overall Survival (OS) | Up to approximately 4 years | |
| Overall Survival Rate at 12 Months (OS-12) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information Group officer | Contact | 86-0311-69085587 | ctr-contact@cspc.cn |
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This is a randomized, controlled, open-label, multicenter, Phase III clinical trial. Participants with recurrent or progressive high-grade meningioma (WHO Grade II and III) who have received surgical resection and radiotherapy and are not eligible for local therapy judged by investigator will be randomized 1:1 to receive either SYHA1813 (experimental group) or investigators' choice (control group) treatment.
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| Drug |
Investigator's Choice Treatment:bevacizumab, temozolomide or hydroxyurea |
|
| Up to approximately 4 years |
| Progression Free Survival Rate at 6 Months (PFS-6) as Assessed by RANO Criteria | Up to approximately 4 years |
| Objective Response Rate (ORR) as Assessed by RANO Criteria | Up to approximately 4 years |
| Disease Control Rate (DCR) as Assessed by RANO Criteria | Up to approximately 4 years |
| Frequency and severity of TEAEs and SAEs | Up to approximately 4 years |
| Cmax of SYHA1813 | Cycles 1, 2, 3 |
| Tmax of SYHA1813 | Cycles 1, 2, 3 |
| AUClast of SYHA1813 | Cycles 1, 2, 3 |
| AUCinf of SYHA1813 | Cycles 1, 2, 3 |
| t1/2 of SYHA1813 | Cycles 1, 2, 3 |