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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vyloy | Patients who receive treatment with Vyloy injection 100 mg or 300 mg (zolbetuximab), according to the approved local label. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zolbetuximab | Drug | Intravenous |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 54 Weeks after the first administration of VYLOY |
| 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. | Up to 54 Weeks after the first administration of VYLOY |
| 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. | Up to 54 Weeks after the first administration of VYLOY |
| 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. | Up to 54 Weeks after the first administration of VYLOY |
| Number of patients with an unexpected AE (UAE) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 54 Weeks after the first administration of VYLOY |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Astellas Pharma Global Development, Inc. | Contact | 800-888-7704 | astellas.registration@astellas.com |
| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Korea, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KR82010 | Recruiting | Goyang-si | Gyeonggi-do | South Korea | ||
| KR82008 |
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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An UAE is an AE that the nature or severity of which is not consistent with the information in the Precautions in Use Section of approved Korean label. |
| Up to 54 Weeks after the first administration of VYLOY |
| Number of patients with an unexpected ADR (UADR) | An UADR is defined as an unexpected adverse drug reaction. | Up to 54 Weeks after the first administration of VYLOY |
| Number of patients who died during the study | Up to 54 Weeks after the first administration of VYLOY |
| Number patients with an AE leading to death | Up to 54 Weeks after the first administration of VYLOY |
| Number of patients with an important risk compared to number of patients evaluated | An important risk is classified as an important identified risk and an important potential risk. An identified risk is defined as the risk that correspond to undesirable clinical outcomes, with sufficient scientific evidence that the undesirable clinical outcome is caused by the drug. "Important Identified Risks" are identified risks that have the potential to affect the risk-benefit balance of a product. An potential risk is defined as the risk that correspond to undesirable clinical outcomes, with some, but not sufficient, evidence to estimate that the undesirable clinical outcome is caused by the drug. "Important Potential Risks" are potential risks that have the potential to affect the risk-benefit balance of a product. | Up to 54 Weeks after the first administration of VYLOY |
| Recruiting |
| Suwon |
| Gyeonggi-do |
| South Korea |
| KR82009 | Recruiting | Suwon | Gyeonggi-do | South Korea |
| KR82006 | Recruiting | Yangsan | Gyeongsangnam-do | South Korea |
| KR82012 | Recruiting | Hwasun Gun | Jeollanam-do | South Korea |
| KR82001 | Recruiting | Seoul | South Korea |
| KR82002 | Recruiting | Seoul | South Korea |
| KR82003 | Recruiting | Seoul | South Korea |
| KR82004 | Recruiting | Seoul | South Korea |
| KR82005 | Recruiting | Seoul | South Korea |
| KR82007 | Recruiting | Seoul | South Korea |
| KR82011 | Recruiting | Seoul | South Korea |
| KR82013 | Recruiting | Seoul | South Korea |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C585662 | zolbetuximab |
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