A Study to Observe the Safety of VYLOY (Zolbetuximab) in People in South Korea With Gastric or Gastroesophageal Junction Cancer.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: zolbetuximab.
- Who it may be relevant to
- Registry conditions: Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Post-marketing Observational Study of VYLOY (Zolbetuximab) Injection 100 mg, 300 mg for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma in South Korea
Overview
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).
Interventions
- Drug zolbetuximab
Intravenous
Primary outcome measures
- Number of patients with an adverse event (AE) [Time frame: Up to 54 Weeks after the first administration of VYLOY]
- Number of patients with an adverse drug reaction (ADR) [Time frame: Up to 54 Weeks after the first administration of VYLOY]
- Number of patients with a serious AE (SAE) [Time frame: Up to 54 Weeks after the first administration of VYLOY]
- Number of patients with a serious ADR (SADR) [Time frame: Up to 54 Weeks after the first administration of VYLOY]
- Number of patients with an unexpected AE (UAE) [Time frame: Up to 54 Weeks after the first administration of VYLOY]
- Number of patients with an unexpected ADR (UADR) [Time frame: Up to 54 Weeks after the first administration of VYLOY]
- Number of patients who died during the study [Time frame: Up to 54 Weeks after the first administration of VYLOY]
- Number patients with an AE leading to death [Time frame: Up to 54 Weeks after the first administration of VYLOY]
- Number of patients with an important risk compared to number of patients evaluated [Time frame: Up to 54 Weeks after the first administration of VYLOY]
Secondary outcome measures (1)
- Progression free survival (PFS) [Time frame: Up to 54 Weeks after the first administration of VYLOY]
Eligibility criteria
Inclusion criteria
- Patients who receive treatment with VYLOY injection, according to the approved local label.
Exclusion criteria
- Patients with any contraindication for VYLOY injection, according to the approved local label.
- Patients who are registered or scheduled to be registered in any clinical trials involving investigational drug administration.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 13 centers
- KR82010 — Goyang-si
- KR82008 — Suwon
- KR82009 — Suwon
- KR82006 — Yangsan
- KR82012 — Hwasun Gun
- KR82001 — Seoul
- KR82002 — Seoul
- KR82003 — Seoul
- … and 5 more centers
Identifiers
NCT: NCT06902545 · 8951-PV-0001