NCT04656002

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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A dose of 80mg/m2 is administered intravenously for 60 minutes at the 1st, 8th, and 15th days of each cycle and is withdrawn for 1 week.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Vactosertib	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

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2020-12-07
• Last updated: 2022-06-15