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An open study to evaluate the safety of apatinib mesylate (YN968D1) 1,000mg monotherapy in patients with unresectable locally advanced or metastatic Gastric cancer failed to standard therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib mesylate | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib mesylate | Drug | 1,000mg Apatinib mesylate p.o. qd |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicities (DLTs) of Apatinib mesylate in patients with unresectable locally advanced or metastatic gastric cancer | Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.03 | First 28 days of dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse events (AEs), Serious AEs (SAEs), clinical laboratory abnormalities, and ECG abnormalities | Incidence and severity of treatment-related adverse events reported and their relationship to Apatinib mesylate will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.3) | From date of registration to time of first progressive disease(PD) or death, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoon-Koo Kang, PhD | Seoul Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan medical center | Seoul | Songpa-gu | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38271925 | Derived | Kang YK, Ryu MH, Hong YS, Choi CM, Kim TW, Ryoo BY, Kim JE, Weis JR, Kingsford R, Park CH, Jang S, McGinn A, Werner TL, Sharma S. Phase 1/2a Study of Rivoceranib, a Selective VEGFR-2 Angiogenesis Inhibitor, in Patients with Advanced Solid Tumors. Cancer Res Treat. 2024 Jul;56(3):743-750. doi: 10.4143/crt.2023.980. Epub 2024 Jan 18. |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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| Duration of Response(Stable disease, partial response or Complete response) | Tumor response and progression will be evaluated using RECIST v 1.1. | From date of registration to time of first progressive disease(PD) or death, an average of 1 year |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |