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Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve progression free survival compared with placebo in patients with metastatic gastric carcinoma who failed two lines of chemotherapy.
Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have been suggested as the first line therapy for A/MGC by FDA, the efficacy of these treatment is still unsatisfied for their toxicity and limitation in prolonging survival. Based on the promising results of apatinib in the phase I study, this clinical trial has been designed to evaluate whether apatinib can improve progression free survival in patients with metastatic gastric carcinoma who failed two lines of chemotherapy compared with placebo. Patients will be randomized to 3 groups, one group patients will receive the treatment of apatinib 850mg qd, one group patients will receive apatinib 425mg bid, and the other group will receive placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A 850 | Experimental | apatinib 850 mg qd, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
|
| B 425 | Experimental | apatinib 425 mg bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
|
| C pla | Placebo Comparator | placebo bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| apatinib tablet | Drug | A850: apatinib 850 mg qd p.o. plus placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent B425: apatinib 425 mg bid p.o. until disease progression or intolerable toxicity or patients withdrawal of consent Cpla: placebo bid p.o. until disease progression or intolerable toxicity or patients withdrawal of consent |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival safety | 8 weeks | |
| DCR (Disease control rate) | 8 weeks | |
| ORR (Objective response rate) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin Li, MD, PHD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Cancer Hospital | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23918952 | Derived | Li J, Qin S, Xu J, Guo W, Xiong J, Bai Y, Sun G, Yang Y, Wang L, Xu N, Cheng Y, Wang Z, Zheng L, Tao M, Zhu X, Ji D, Liu X, Yu H. Apatinib for chemotherapy-refractory advanced metastatic gastric cancer: results from a randomized, placebo-controlled, parallel-arm, phase II trial. J Clin Oncol. 2013 Sep 10;31(26):3219-25. doi: 10.1200/JCO.2013.48.8585. Epub 2013 Aug 5. |
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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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|
| 8 weeks |
| QoL (Quality of life) | 8 weeks |
| Toxicity | 8 weeks |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |