Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT04656002
Status:
UNKNOWN
Last Update Posted:
2022-06-15
First Post:
2020-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
As a Second-line Treatment for Metastatic Gastric Adenocarcinoma Patients, the Safety and Effective of Vactosertib Administration in Combination With Paclitaxel+Ramucirumab is Evaluated, and a Phase 2a Clinical Trial to Biomarkers
Sponsor:
Samsung Medical Center
Organization:
Study Overview
Official Title:
As a Second-line Treatment for Metastatic Gastric Adenocarcinoma Patients, the Safety and Effective of Vactosertib Administration in Combination With Paclitaxel+Ramucirumab is Evaluated, and a Phase 2a Clinical Trial to Biomarkers
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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A dose of 80mg/m2 is administered intravenously for 60 minutes at the 1st, 8th, and 15th days of each cycle and is withdrawn for 1 week.
\[Bactosertib／TEW-7197\] 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: