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This clinical trial is to evaluate the efficacy and safety of subjects with metastatic gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction. In addition, this clinical trial is performed to analyze the genome-specific response rate and genome analysis to identify predictive markers that respond to investigational drug administration.
4 weeks (28 days) administration is considered as 1 cycle.
[Bactosertib/TEW-7197] A 300mg dose is administered orally as tablets twice a day for 5 days, followed by a 2 day holiday. (5 days medication/2 days off). All doses are taken in the morning/evening, approximately 12 hours apart, regardless of food.
[Ramucirumab (ramucirumab)] A dose of 8 mg/kg (8 mg per kg of body weight) is administered once for 60 minutes at the 1st and 15th days of each cycle. This drug is administered directly into a blood vessel using an infusion pump.
[paclitaxel (paclitaxel)] A dose of 80mg/m2 is administered intravenously for 60 minutes at the 1st, 8th, and 15th days of each cycle and is withdrawn for 1 week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel, Ramucirumab + TEW-7197 | Experimental | Take Baektoseotip (TEW-7197) twice a day for 5 days and take a break for 2 days (5D on/2D off). With this method, progression up to the 28th day is taken as one cycle. Take it with or without food every twelve hours -Paclitaxel, Ramucirumab Intravenous (IV) Ramucirumab injection, provided as a single-use 500-mg/50-mL vial containing 10 mg/mL of product in histidine buffer, with disease progression, toxicity requiring discontinuation, or without interruption for any reason. After diluting to 8 mg/kg every 2 weeks, IV It is administered by infusion. Paclitaxel is administered at a dose of 80 mg/m2 on days 1, 8 and 15 of a 28-day cycle, with disease progression, toxicity requiring discontinuation, or without interruption for any reason. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vactosertib | Drug | Take Baektoseotip (TEW-7197) twice a day for 5 days and take a break for 2 days (5D on/2D off). With this method, progression up to the 28th day is taken as one cycle. Take it with or without food every twelve hours |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | up to 24momths |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate | up to 24momths |
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Inclusion Criteria:
etc
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SeungTae Kim, PhMD | Contact | 82-2-3410-3459 | seungtae1.kim@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| SeungTae Kim, PhMD | Samsung Medical Center | Principal Investigator |
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TEW-7197 300 mg BID 5D on/2D off
+ Ramucirumab IV 8 mg/kg every 2weeks +Paclitaxel 80 mg/m2 day1.8.15 every 28days
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|
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C000590371 | vactosertib |
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