A Study to Survey Adults in South Korea With Cancer Who Receive PADCEV Injection
- Conditions
- Urothelial Cancer
- Interventions
- Drug: Enfortumab Vedotin
- Registration Number
- NCT06011954
- Lead Sponsor
- Astellas Pharma Korea, Inc.
- Brief Summary
Enfortumab vedotin (or PADCEV Injection) is a treatment for cancer in the bladder lining (urothelial cancer). PADCEV Injection is now available to treat this cancer.
People in this study will be adults in South Korea with locally advanced or metastatic urothelial cancer. Metastatic means the cancer has spread to other parts of the body. During their care, the person's doctor will have prescribed PADCEV Injection and other medicines to treat their cancer. People in the study will be treated according to their clinic's standard practice. This study is about collecting information only.
This study will survey people who know they are receiving PADCEV Injection. The aims of the study are to check outcomes of treatment with PADCEV and record any medical problems during the study.
Once a doctor has prescribed PADCEV Injection, a person in the study will be observed for up to 48 weeks (about 1 year) after their first dose. During this time, a person's medical records will be reviewed to check for any medical problems and to follow the condition of their cancer. If a person in the study stops taking PADCEV Injection sooner than 48 weeks, records will be reviewed until 30 days (1 month) after each person's last dose of PADCEV Injection or until they start a different medicine for their cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 235
- Patients who receive treatment with PADCEV Injection, according to the approved local label.
- Patients with any contraindication for PADCEV Injection, according to the approved local label.
- Patients who receive or are going to receive any investigational medicine during the observation period.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PADCEV Enfortumab Vedotin Patients who receive PADCEV Injection 20 mg and 30 mg (enfortumab vedotin) in routine clinical practice according to the drug label approved at the time of marketing authorization.
- Primary Outcome Measures
Name Time Method Number of patients with an Adverse Event Up to 48 weeks after the first administration of PADCEV Adverse events (AEs) will be summarized using MedDRA. An AE is defined as any untoward medical occurrence in a subject 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 48 weeks after the first administration of PADCEV 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 48 weeks after the first administration of PADCEV An AE is considered "serious" if it results in death or is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a medically important event or reaction.
Number of patients with a serious ADR (SADR) Up to 48 weeks after the first administration of PADCEV An ADR is considered "serious" if it results in death or is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a medically important event or reaction.
Number of patients with an unexpected AE (UAE) Up to 48 weeks after the first administration of PADCEV An UAE is an AE that the nature or severity of which is not consistent with the information in the approved Korean label.
Number of patients with an unexpected ADR (UADR) Up to 48 weeks after the first administration of PADCEV An UADR is defined as an unexpected adverse drug reaction.
Number of patients with an important risk Up to 48 weeks after the first administration of PADCEV 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 Outcome Measures
Name Time Method Overall survival Up to 48 weeks after the first administration of PADCEV Overall survival (OS) is defined as time from start of PADCEV to death.
Progression free survival Up to 48 weeks after the first administration of PADCEV Progression free survival (PFS) is defined as time from start of PADCEV to progressive disease (PD) or death from any cause, whichever occurs first.
Trial Locations
- Locations (17)
Site KR82006
🇰🇷Seoul, Korea, Republic of
Site KR82011
🇰🇷Seoul, Korea, Republic of
Site KR82001
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Site KR82012
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of
Site KR82008
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of
Site KR82013
🇰🇷Jeonju-si, Jeonbuk-do, Korea, Republic of
Site KR82015
🇰🇷Busan, Korea, Republic of
Site KR82010
🇰🇷Busan, Korea, Republic of
Site KR82009
🇰🇷Busan, Korea, Republic of
Site KR82016
🇰🇷Busan, Korea, Republic of
Site KR82014
🇰🇷Daegu, Korea, Republic of
Site KR82004
🇰🇷Incheon, Korea, Republic of
Site KR82007
🇰🇷Jeollanam-do, Korea, Republic of
Site KR82002
🇰🇷Seoul, Korea, Republic of
Site KR82005
🇰🇷Seoul, Korea, Republic of
Site KR82003
🇰🇷Seoul, Korea, Republic of
Site KR82017
🇰🇷Seoul, Korea, Republic of