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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 377
- 试验地点
- 24
- 主要终点
- Number of patients with an unexpected ADR (UADR)
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who receive treatment with VYLOY injection, according to the approved local label.
排除标准
- •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.
研究组 & 干预措施
Vyloy
Patients who receive treatment with Vyloy injection 100 mg or 300 mg (zolbetuximab), according to the approved local label.
干预措施: zolbetuximab (Drug)
结局指标
主要结局
Number of patients with an unexpected ADR (UADR)
时间窗: Up to 54 Weeks after the first administration of VYLOY
An UADR is defined as an unexpected adverse drug reaction.
Number of patients with a serious ADR (SADR)
时间窗: 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)
时间窗: 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 who died during the study
时间窗: Up to 54 Weeks after the first administration of VYLOY
Number patients with an AE leading to death
时间窗: Up to 54 Weeks after the first administration of VYLOY
Number of patients with a serious AE (SAE)
时间窗: 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 an adverse drug reaction (ADR)
时间窗: 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 an adverse event (AE)
时间窗: 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 important risk compared to number of patients evaluated
时间窗: 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.
次要结局
- Progression free survival (PFS)(Up to 54 Weeks after the first administration of VYLOY)