Afatinib, Paclitaxel, 2nd Line, Advanced Gastric Cancer

NCT02501603 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2023-01-27

No results posted yet for this study

Summary

For the gastric cancer, paclitaxel is recommended as salvage standard treatment. Afatinib is a novel, potent, small ErbB family blocker that covalently binds and irreversibly blocks signaling through activated EGFR, HER2 and ErbB4 receptors, as well as the transphosphorylation of ErbB3. The investigators suggest a randomized phase II trial of afatinib plus weekly taxol(paclitaxel) for previously treated EGFR positive gastric cancer patients. The aim of current trial is to evaluate the antitumor efficacy of afatinib for target enriched patients in gastric cancer.

Conditions

Interventions

DRUG

afatinib

Afatinib 40mg daily oral administration

DRUG

paclitaxel

Paclitaxel 80mg/m2 IV weekly (day 1,8,15)

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Sun Young Rha · Severance Hospital, Yonsei University Health System, Yonsei Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2021-12-31
Completion
2022-12-20

Countries

  • South Korea

Study Locations

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Entities

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 NCT02501603 on ClinicalTrials.gov