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| Name | Class |
|---|---|
| Sun Yat-sen University | OTHER |
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RATIONALE: Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study has shown that the drug's toxicity is manageable.
PURPOSE: This phase II trial is studying how well famitinib works in treating patients with recurrent and/or metastatic NPC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: Famitinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Famitinib | Drug | 25 mg qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
|
| Measure | Description | Time Frame |
|---|---|---|
| CBR(Clinical Benefit Rate) | To evaluate the efficacy (clinical benefit rate) of single-agent famitinib in patients with recurrent or metastatic NPC | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ORR (Objective Response Rate) | 12 weeks | |
| PFS(Progress Free Survival) | 3 years | |
| DCR(Disease Control Rate) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medical Oncology, Cancer Center, Sun Yet-sen University | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C584390 | famitinib |
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| 12 weeks |
| OS(Sverall Survival) | 3 years |
| To evaluate the safety and tolerability | Number of participants with adverse events and serious adverse events.In addition,estimating their relationship with Famitinib. | 3 years |
| QoL(Quality of Life) | 3 years |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |