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
Conditions
Keywords
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma Cancer, Metastatic Gastric Adenocarcinoma Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma, Claudin 18.2, Human epidermal growth factor receptor 2 (HER2) Negative, zolbetuximab, Pharmcovigilence
Brief 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).
Interventions
DRUGzolbetuximab
Intravenous
Sponsors
Astellas Pharma Korea, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with an adverse event (AE) | Up to 54 Weeks after the first administration of VYLOY | 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. |
| Number of patients with an adverse drug reaction (ADR) | Up to 54 Weeks after the first administration of VYLOY | 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. |
| Number of patients with a serious AE (SAE) | Up to 54 Weeks after the first administration of VYLOY | 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. |
| Number of patients with a serious ADR (SADR) | Up to 54 Weeks after the first administration of VYLOY | 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. |
| Number of patients with an unexpected AE (UAE) | Up to 54 Weeks after the first administration of VYLOY | 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. |
| Number of patients with an unexpected ADR (UADR) | Up to 54 Weeks after the first administration of VYLOY | An UADR is defined as an unexpected adverse drug reaction. |
| 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 | Up to 54 Weeks after the first administration of VYLOY | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | Up to 54 Weeks after the first administration of VYLOY | PFS is defined as time from start of VYLOY to progressive disease (PD) or death from any cause, whichever occurs first. |
Countries
South Korea
Contacts
CONTACTAstellas Pharma Global Development, Inc.
STUDY_DIRECTORCentral Contact
Astellas Pharma Korea, Inc.
Outcome results
None listed