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

NCT04656002 | Unknown Phase 2

• 1 other identifier: 2020-05-175
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  up to 24momths

Secondary Outcomes (1)

• Disease control rate

  up to 24momths

Study Arms (1)

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.

Drug: Vactosertib

Interventions

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

Also known as: TEW-7197

Paclitaxel, Ramucirumab + TEW-7197

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically or cytologically confirmed gastric cancer, including gastric adenocarcinoma or GEJ adenocarcinoma.
• Patients with metastatic or locally recurrent unresectable disease.
• Patients with diseased lesions that can be measured using standard computed tomography (CT) or magnetic resonance imaging (MRI).
• Patients who have experienced disease progression during or after primary therapy for metastatic disease.
• Patients over 19 years of age.
• 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).
• Patients with an Eastern Oncology Cooperative Group Performance Status (ECOG PS) score of 0 or 1.
• 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

You may not qualify if:

• Patients previously receiving treatment targeting the TGF-β signaling pathway
• Patients who previously received Taxane-based chemotherapy
• Patients with recorded and/or symptomatic brain or meningeal metastases.
• Patients who experienced Grade 3-4 GI bleeding within 3 months prior to enrollment.
• 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.
• 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.
• Patients with ongoing or active psychiatric conditions or social situations that may limit adherence to treatment.
• Patients with uncontrolled or poorly controlled hypertension (systolic \>160 mmHg or diastolic \>100 mmHg for \>4 weeks) despite standard medical care.

Sponsors & Collaborators

• Samsung Medical Center: lead

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

vactosertib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• SeungTae Kim, PhMD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SeungTae Kim, PhMD

CONTACT

82-2-3410-3459; seungtae1.kim@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PH,MD

Model Details: 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

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: October 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: June 15, 2022

Record last verified: 2022-06