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An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for refractory primary brain tumors with BRAF mutation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HLX208 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLX208 | Drug | 450mg bid po |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate(assessed by independent radiological review committee (IRRC) based on the RANO | from first dose to the last patient was followed up for 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression-free survival(PFS):assessed by IRRC and the investigator based on the RANO | from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),an average of about 1 year |
| DOR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinming Yu | Contact | 0531-67626819 | sdyujinming@126.com | |
| Zhehai Wang | Contact | 0531-67626073 | ywb234@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jinming Yu | Shandong Cancer Hospital and Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Affiliated to Shandong first medical University | Recruiting | Jinan | Shandong | 250117 | China |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Duration of response
| from the first occurrence of a documented CR or PR (whichever recorded earlier) to the time of first documented disease progression or death (whichever occurs first),an average of about 1 year |
| OS | Overall survival | from the first dose to the time of death due to any cause,an average of about 2 year |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |