Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Seagen Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PADCEV | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enfortumab Vedotin | Drug | Intravenous |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with an Adverse Event | 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. | Up to 48 weeks after the first administration of PADCEV |
| 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 48 weeks after the first administration of PADCEV |
| Number of patients with a serious AE (SAE) | 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. | Up to 48 weeks after the first administration of PADCEV |
| Number of patients with a serious ADR (SADR) | 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. | Up to 48 weeks after the first administration of PADCEV |
| Number of patients with an unexpected AE (UAE) | An UAE is an AE that the nature or severity of which is not consistent with the information in the approved Korean label. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival (OS) is defined as time from start of PADCEV to death. | Up to 48 weeks after the first administration of PADCEV |
| Progression free survival | Progression free survival (PFS) is defined as time from start of PADCEV to progressive disease (PD) or death from any cause, whichever occurs first. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|---|---|---|
| Site KR82001 | Recruiting | Goyang-si | Gyeonggi-do | 10408 | South Korea | |
| Site KR82012 |
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/.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 48 weeks after the first administration of PADCEV |
| Number of patients with an unexpected ADR (UADR) | An UADR is defined as an unexpected adverse drug reaction. | Up to 48 weeks after the first administration of PADCEV |
| Number of patients with an important risk | 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 48 weeks after the first administration of PADCEV |
| Up to 48 weeks after the first administration of PADCEV |
| Recruiting |
| Suwon |
| Gyeonggi-do |
| 16247 |
| South Korea |
| Site KR82008 | Recruiting | Suwon | Gyeonggi-do | 16500 | South Korea |
| Site KR82007 | Completed | Jeollanam-do | Jeollanam-do | 58128 | South Korea |
| Site KR82013 | Recruiting | Jeonju | Jeonbuk-do | 54907 | South Korea |
| Site KR82015 | Active, not recruiting | Busan | 47392 | South Korea |
| Site KR82010 | Completed | Busan | 48108 | South Korea |
| Site KR82009 | Active, not recruiting | Busan | 49201 | South Korea |
| Site KR82016 | Completed | Busan | 50612 | South Korea |
| Site KR82014 | Recruiting | Daegu | 42415 | South Korea |
| Site KR82018 | Recruiting | Daejeon | 35365 | South Korea |
| Site KR82004 | Active, not recruiting | Incheon | 21565 | South Korea |
| Site KR82002 | Recruiting | Seoul | 02841 | South Korea |
| Site KR82005 | Recruiting | Seoul | 03181 | South Korea |
| Site KR82003 | Recruiting | Seoul | 03722 | South Korea |
| Site KR82017 | Active, not recruiting | Seoul | 06351 | South Korea |
| Site KR82006 | Recruiting | Seoul | 07417 | South Korea |
| Site KR82011 | Recruiting | Seoul | 07985 | South Korea |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000632577 | enfortumab vedotin |
Not provided
Not provided
Not provided