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This is an open-label study, to evaluated epitinib, which is a selective epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), to treat glioblastoma patients with EGFR gene amplification. As epitinib could cross blood-brain barrier (BBB), inhibition of EGFR may provide a novel mechanism in treating glioblastoma.
Epitinib could cross BBB and show its efficacy in brain metastasis tumors. Patients with histologically confirmed glioblastoma; standard treatment failed or no standard treatment as well as EGFR gene amplication are eligible. Patients will receive epitinib 120mg or 160mg epitinib daily. Epitinib is orally administered qd until patients reach intolerance or progression of disease. Tumor assessment takes place every 4 weeks. Simon two stage design was used, estimated making sample size of 35 cases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental | This is a single arm study. It is an open-label study. The intervention is eptinib succinate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| epitinib succinate | Drug | This is a single-arm open label study. A subject would take 160 mg of the study medication (epitinib succinate) every day on a 28-day cycle, until he or she reaches disease progression or intolerability. |
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate (ORR) | the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rongjun Liu, M.D. | Contact | 86-21-2067-3203 | rongjunl@hmplglobal.com | |
| Yan Wu, M.D. | Contact | 86-21-2067-3000 | 5830 | yanwu@hmplglobal.com |
| Name | Affiliation | Role |
|---|---|---|
| Rongjun Liu, M.D. | Hutchison Medipharma Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200031 | China |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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This is a single arm, open label study with fixed dose.
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| The second hospital affiliated to Zhejiang University Medical School | Recruiting | Hanzhou | Zhejiang | 310009 | China |
|
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |