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Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of zolbetuximab plus capecitabine and oxaliplatin (CAPOX) compared with placebo plus CAPOX (as first-line treatment) as measured by Progression Free Survival (PFS). This study will also evaluate efficacy, physical function, safety, and tolerability of zolbetuximab, as well as its effects on quality of life. Pharmacokinetics (PK) of zolbetuximab and the immunogenicity profile of zolbetuximab will be evaluated as well.


Clinical Trial Description

The study consists of the following periods: screening; treatment; post-treatment follow up, safety follow up, long term and survival follow-up. After the marketing approval in Japan on 26 Mar 2024, this study continued as "post marketing clinical study" in Japan. In the rest of the countries which participated in this study, this study continued as clinical study. ;


Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer
  • Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer
  • Metastatic Gastric Adenocarcinoma or Cancer
  • Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

NCT number NCT03653507
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Active, not recruiting
Phase Phase 3
Start date November 28, 2018
Completion date March 31, 2025

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03504397 - A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer Phase 3
Available NCT06048081 - Early Access Program for Zolbetuximab