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A Study to Observe the Safety of VYLOY (Zolbetuximab) in People in South Korea With Gastric or Gastroesophageal Junction Cancer.

ConditionsLocally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or CancerLocally Advanced Unresectable Gastric Adenocarcinoma or CancerMetastatic Gastric Adenocarcinoma or CancerMetastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAstellas Pharma Korea, Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

Patients who have locally advanced unresectable or metastatic HER2-negative, and CLDN18.2-positive, gastric or GEJ adenocarcinoma who are prescribed VYLOY injection in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first line treatment in South Korea.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • zolbetuximab

    Drug

    Intravenous

Treatment groups

377 Participants
are divided into 1 treatment group
Group A: Vyloy1 intervention

Trial outcomes

Primary outcomes

1

Number of patients with an adverse event (AE)

Adverse events (AEs) will be coded using MedDRA. An AE is defined as any untoward medical occurrence in a patient administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.

Time frame
Up to 54 Weeks after the first administration of VYLOY
2

Number of patients with an adverse drug reaction (ADR)

An ADR is defined as any noxious and unintended response associated with the use of a drug in humans, at any dose, where a causal relationship is at least a reasonable possibility.

Time frame
Up to 54 Weeks after the first administration of VYLOY
3

Number of patients with a serious AE (SAE)

An AE is considered "serious" if, in the view of either the investigator or sponsor, the event: results in death, is life-threatening, requires hospitalization or prolongation to hospitalization results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect, or other medically important event.

Time frame
Up to 54 Weeks after the first administration of VYLOY
4

Number of patients with a serious ADR (SADR)

An ADR considered "serious" if, in the view of either the investigator or sponsor, the event: results in death, is life-threatening, requires hospitalization or prolongation to hospitalization results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect, or other medically important event.

Time frame
Up to 54 Weeks after the first administration of VYLOY

Secondary outcomes

1

Progression free survival (PFS)

PFS is defined as time from start of VYLOY to progressive disease (PD) or death from any cause, whichever occurs first.

Time frame
Up to 54 Weeks after the first administration of VYLOY

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Astellas Pharma Korea, Inc.

Lead sponsor

Source ClinicalTrials.gov
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