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Trastuzumab Beyond Progression in HER2 Positive Metastatic Gastric Cancer

NCT03766607 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-09-19

No results posted yet for this study

Summary

The aim of this study is to evaluate the efficacy and safety of combination therapy with ramucirumab, paclitaxel, and trastuzumab biosimilar as second line treatment of HER2 positive metastatic gastric cancer after failure of first line chemotherapy including trastuzumab. This study is a phase II, single-arm, open label, multi-center study.

Conditions

Interventions

DRUG

Trastuzumab

Trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) administered intravenously every 21 days

DRUG

Ramucirumab

Ramucirumab 8 mg/kg administered intravenously on days 1 and 15 every 28 days

DRUG

Paclitaxel

Paclitaxel 80 mg/m2 administered intravenously on days 1, 8, and 15 every 28 days

Sponsors & Collaborators

  • Korean South West Oncology Group

    lead NETWORK

Principal Investigators

  • Eun-Kee Song · Korean Southwest Oncology Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2021-12-31
Completion
2022-06-30

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03766607 on ClinicalTrials.gov