Post-marketing Observational Study of VYLOY (Zolbetuximab) Injection 100 mg for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma in South Korea

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

This study is for people in South Korea who have cancer in or around the stomach (gastric cancer) or cancer where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Their cancer is locally advanced, unresectable, or metastatic. Locally advanced means the cancer has spread to tissue close by. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. In South Korea, VYLOY is approved for the treatment of gastric cancer or GEJ cancer. The people in this study will receive VYLOY as part of their usual treatment for their cancer. In standard clinical practice VYLOY is given to people slowly through a tube into a vein. The main aim of the study is to collect information in a real-world setting about the safety of VYLOY in people with gastric cancer or GEJ cancer in clinics in South Korea. This study will also help researchers learn how long people's gastric cancer or GEJ cancer stays stable. This study is about collecting information only. This is known as an observational study. The individual's doctor decides on treatment, not the sponsor (Astellas). The study will last about 1 year (54 weeks).

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Patients who receive treatment with VYLOY injection, according to the approved local label.

Locations
Other Locations
Republic of Korea
KR82010
RECRUITING
Goyang-si
KR82012
RECRUITING
Hwasun Gun
KR82001
RECRUITING
Seoul
KR82002
RECRUITING
Seoul
KR82003
RECRUITING
Seoul
KR82004
RECRUITING
Seoul
KR82005
RECRUITING
Seoul
KR82011
RECRUITING
Seoul
KR82008
RECRUITING
Suwon
KR82006
RECRUITING
Yangsan
Contact Information
Primary
Astellas Pharma Global Development, Inc.
astellas.registration@astellas.com
800-888-7704
Time Frame
Start Date: 2025-04-03
Estimated Completion Date: 2030-07-31
Participants
Target number of participants: 377
Treatments
Vyloy
Patients who receive treatment with Vyloy injection 100 mg (zolbetuximab), according to the approved local label.
Related Therapeutic Areas
Sponsors
Leads: Astellas Pharma Korea, Inc.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials