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There is strong scientific rationale for exploring the role of sorafenib with capecitabine and cisplatin (XP) in AGC. XP is a new standard of care in AGC and sorafenib is a novel signal transduction inhibitor that prevents tumor cell proliferation and angiogenesis through blockade of the Raf/MEK/ERK pathway at the level of Raf kinase and the receptor tyrosine kinases VEGF-R2 and PDGFR-beta.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | XP+sorafenib |
|
| B | Placebo Comparator | XP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine, Cisplatin, Sorafenib | Drug | Capecitabine ( ) mg/m2 bid D1-D15 Cisplatin 80 mg/m2 D1 Sorafenib ( ) mg bid PO daily every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Number of Participants who Experienced Dose Limiting Toxicities (DLTs) | 28weeks |
| Progression-free Survival | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | Tumor response was assessed every two cycles by RECIST(v1.0) using the same imaging techniques and methods used at baseline. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoon-Koo Kang, MD, PhD | Asan Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 138-736 | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | XP Plus Sorafenib | Capecitabine and cisplatin plus sorafenib Level 1 sorafenib 400 mg/d, capecitabine 1,600 mg/m2/d, cisplatin 80 mg/m2 Level 2 sorafenib 800 mg/d, capecitabine 1,600 mg/m2/d, cisplatin 80 mg/m2 Level 3 sorafenib 800 mg/d, capecitabine 2,000 mg/m2/d, cisplatin 80 mg/m2 Level 1A sorafenib 800 mg/d, capecitabine 1,600 mg/m2/d, cisplatin 60 mg/m2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled patients were analyzed for analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | XP Plus Sorafenib | Capecitabine and cisplatin plus sorafenib |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Number of Participants who Experienced Dose Limiting Toxicities (DLTs) | Posted | Number | participants | 28weeks |
|
|
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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 | XP Plus Sorafenib | Capecitabine and cisplatin plus sorafenib |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | NCI_CTCAE_v3.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | NCI_CTCAE_v3.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yoon-Koo Kang | Asan Medical Center | +82-2-3010-3210 | ykkang@amc.seoul.kr |
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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 |
|---|---|
| D000069287 | Capecitabine |
| D002945 | Cisplatin |
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| 6 months |
| Overall Survival | 28 months |
| Toxicity Profile (According to National Cancer Institute Common Terminology Criteria for Adverse Event Version 3.0) | Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of Capecitabine and cisplatin plus sorafenib | 28weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Progression-free Survival | Posted | Median | 95% Confidence Interval | Months | 1 year |
|
|
|
| Secondary | Response Rate | Tumor response was assessed every two cycles by RECIST(v1.0) using the same imaging techniques and methods used at baseline. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate | Patients who had measurable lesions were included for the response rates | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
|
|
|
| Secondary | Overall Survival | Posted | Median | 95% Confidence Interval | Months | 28 months |
|
|
|
| Secondary | Toxicity Profile (According to National Cancer Institute Common Terminology Criteria for Adverse Event Version 3.0) | Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of Capecitabine and cisplatin plus sorafenib | Posted | Number | participants | 28weeks |
|
|
|
| 4 |
| 21 |
| 21 |
| 21 |
| Febrile neutropenia | Blood and lymphatic system disorders | NCI_CTCAE_v3.0 | Systematic Assessment |
|
| Deep vein thrombosis | Blood and lymphatic system disorders | NCI_CTCAE_v3.0 | Systematic Assessment |
|
| Gastric perforation | Gastrointestinal disorders | NCI_CTCAE_v3.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | NCI_CTCAE_v3.0 | Systematic Assessment |
|
| Febrile neutropenia | Infections and infestations | NCI_CTCAE_v3.0 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | NCI_CTCAE_v3.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | NCI_CTCAE_v3.0 | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | NCI_CTCAE_v3.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | NCI_CTCAE_v3.0 | Systematic Assessment |
|
| Asthenia | General disorders | NCI_CTCAE_v3.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | NCI_CTCAE_v3.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | NCI_CTCAE_v3.0 | Systematic Assessment |
|
| Sensory neuropathy | Nervous system disorders | NCI_CTCAE_v3.0 | Systematic Assessment |
|
| Skin rash | Skin and subcutaneous tissue disorders | NCI_CTCAE_v3.0 | Systematic Assessment |
|
| Hand-foot syndrome | Skin and subcutaneous tissue disorders | NCI_CTCAE_v3.0 | Systematic Assessment |
|
| Hypertension | Cardiac disorders | NCI_CTCAE_v3.0 | Systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D011725 | Pyridines |