A Study to Survey Adults in South Korea With Cancer Who Receive PADCEV Injection

Urothelial Cancer Clinical Trial

Official title:

Use-result Surveillance for PADCEV Injection 20 mg and 30 mg (Enfortumab Vedotin) in South Korea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06011954
• Other study ID #: 7465-PV-0001
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: July 31, 2027

Study information

• Verified date: April 2024
• Source: Astellas Pharma Inc
• Contact: Astellas Pharma Global Development, Inc.
• Phone: 800-888-7704
• Email: astellas.registration[@]astellas.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 235
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who receive treatment with PADCEV Injection, according to the approved local label.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Urothelial Cancer

Intervention

Drug:
• Enfortumab Vedotin
Intravenous

Locations

Country	Name	City	State
Korea, Republic of	Site KR82001	Seoul
Korea, Republic of	Site KR82002	Seoul
Korea, Republic of	Site KR82003	Seoul
Korea, Republic of	Site KR82004	Seoul
Korea, Republic of	Site KR82005	Seoul
Korea, Republic of	Site KR82007	Seoul
Korea, Republic of	Site KR82008	Seoul
Korea, Republic of	Site KR82009	Seoul
Korea, Republic of	Site KR82010	Seoul
Korea, Republic of	Site KR82011	Seoul
Korea, Republic of	Site KR82013	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Korea, Inc.	Seagen Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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.	Up to 48 weeks after the first administration of PADCEV
Primary	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
Primary	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
Secondary	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
Secondary	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.	Up to 48 weeks after the first administration of PADCEV