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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: Vactosertib

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A dose of 80mg/m2 is administered intravenously for 60 minutes at the 1st, 8th, and 15th days of each cycle and is withdrawn for 1 week.

• Study Type: Interventional
• Enrollment (Anticipated): 43
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: SeungTae Kim, PhMD; Phone Number: 82-2-3410-3459; Email: seungtae1.kim@samsung.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with histologically or cytologically confirmed gastric cancer, including gastric adenocarcinoma or GEJ adenocarcinoma.
2. Patients with metastatic or locally recurrent unresectable disease.
3. Patients with diseased lesions that can be measured using standard computed tomography (CT) or magnetic resonance imaging (MRI).
4. Patients who have experienced disease progression during or after primary therapy for metastatic disease.
5. Patients over 19 years of age.
6. All clinically significant toxic effects of previous chemotherapy, surgery, radiation therapy, or hormone therapy are rated ≤1 (or neuropathic Cases ≤2 grade) (excluding hair loss).
7. Patients with an Eastern Oncology Cooperative Group Performance Status (ECOG PS) score of 0 or 1.
8. Total bilirubin ≤1.5 mg/dL (25.65 µmol/L), and aspartic acid aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x upper limit of normal (ULN; or 5.0 x with liver metastasis) Patients with adequate liver function as defined by ULN).

etc

Exclusion Criteria:

1. Patients previously receiving treatment targeting the TGF-β signaling pathway
2. Patients who previously received Taxane-based chemotherapy
3. Patients with recorded and/or symptomatic brain or meningeal metastases.
4. Patients who experienced Grade 3-4 GI bleeding within 3 months prior to enrollment.
5. Patients who have experienced arterial thromboembolic events including, but not limited to, myocardial infarction, transient ischemic attack, cerebrovascular attack, or unstable angina within 6 months prior to enrollment.
6. Ongoing or active infection, symptomatic congestive heart failure, unstable angina, symptomatic or poorly controlled cardiac arrhythmias, uncontrolled thrombotic or hemorrhagic disease, interstitial pneumonia or pulmonary fibrosis, or in the judgment of the treating physician. Patients with other serious medical conditions that are not controlled.
7. Patients with ongoing or active psychiatric conditions or social situations that may limit adherence to treatment.
8. Patients with uncontrolled or poorly controlled hypertension (systolic >160 mmHg or diastolic >100 mmHg for >4 weeks) despite standard medical care.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Paclitaxel, Ramucirumab + TEW-7197; 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.

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; Other Names: TEW-7197

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective response rate	up to 24momths

Secondary Outcome Measures

Outcome Measure	Time Frame
Disease control rate	up to 24momths

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: SeungTae Kim, PhMD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2022
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (ACTUAL): December 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: 2020-05-175

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No