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| Name | Class |
|---|---|
| Fudan University | OTHER |
| The 81 Hospital of PLA | UNKNOWN |
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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 or overall survival compared with placebo in patients with metastatic gastric carcinoma who failed two lines of chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| apatinib | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| apatinib | Drug | apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival(PFS) | Progression free survival of All the Evaluable Participants.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of diameters of target lesions, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | 30 months |
| Overall Survival(OS) | Overall Survival of the Participants | 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate(DCR) | Disease control is defined as the proportion of patients who had a best response rating of complete response, partial response, or stable disease, and lasted at least 4 weeks. | 30 months |
| Objective Response Rate(ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin Li, MD, PHD | Fudan University | Principal Investigator |
| Shukui Qin, MD | The 81 Hospital of PLA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 81 Hosiptal of PLA | Nanjing | Jiangsu | China | |||
| Fudan University cancer hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Apatinib | apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent |
| FG001 | Placebo | placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
5 participants in the apatinib group and 1 in the placebo group withdrew from the study before receiving the assigned treatments.As a result,267 randomly assigned participants were included in Full Analysis Set （FAS），with 176 assigned to the apatinib group and 91 assigned to the placeo group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Apatinib | apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent |
| BG001 | Placebo | placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival(PFS) | Progression free survival of All the Evaluable Participants.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of diameters of target lesions, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Posted | Median | 95% Confidence Interval | month | 30 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Apatinib | apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| proteinuria | Renal and urinary disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Co-Director of Clinical Trials | Fudan University Shanghai Cancer Center, Shanghai; PLA Cancer Centre, The 81 Hospital of PLA, Nangjing | 021-64433755 | fudanlijin@163.com,qinsk@csco.org.cn |
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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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| placebo | Drug | placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent |
|
Objective Response Rate is defined as the proportion of patients with complete response(CR) or partial response(PR)
| 30 months |
| Percentage of Participants With Adverse Events | 30 months |
| Shanghai |
| Shanghai Municipality |
| China |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Lack of Efficacy |
|
| Protocol Violation |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Overall Survival(OS) | Overall Survival of the Participants | Posted | Median | 95% Confidence Interval | month | 30 months |
|
|
|
| Secondary | Disease Control Rate(DCR) | Disease control is defined as the proportion of patients who had a best response rating of complete response, partial response, or stable disease, and lasted at least 4 weeks. | Posted | Number | percentage of participants | 30 months |
|
|
|
| Secondary | Objective Response Rate(ORR) | Objective Response Rate is defined as the proportion of patients with complete response(CR) or partial response(PR) | Posted | Number | percentage of participants | 30 months |
|
|
|
| Secondary | Percentage of Participants With Adverse Events | Posted | Number | percentage of participants | 30 months |
|
|
|
| 6 |
| 176 |
| 173 |
| 176 |
| EG001 | Placebo | placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent | 6 | 91 | 82 | 91 |
| Gastrointestinal bleeding | Gastrointestinal disorders |
|
| hypertension | Vascular disorders |
|
| hand-foot syndrome | Skin and subcutaneous tissue disorders |
|
| elevated transaminase | Hepatobiliary disorders |
|
| hyperbilirubinemia | Hepatobiliary disorders |
|
| bleeding | Blood and lymphatic system disorders |
|
| fatigue | General disorders |
|
| ALP increased | Hepatobiliary disorders |
|
| elevated GGT | Hepatobiliary disorders |
|
| abdominal pain | Gastrointestinal disorders |
|
| decreased appetite | Metabolism and nutrition disorders |
|
| hypoproteinemia | Metabolism and nutrition disorders |
|
| diarrhea | Gastrointestinal disorders |
|
| elevated LDH | Investigations |
|
| leukopenia | Blood and lymphatic system disorders |
|
| neutropenia | Blood and lymphatic system disorders |
|
| anemia | Blood and lymphatic system disorders |
|
| thrombocytopenia | Blood and lymphatic system disorders |
|
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |