Spots Global Cancer Trial Database for A Post Marketing Surveillance on Piqray in Korea
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Trial Identification
Brief Title: A Post Marketing Surveillance on Piqray in Korea
Official Title: A Post Marketing Surveillance on Piqray (Alpelisib) in Korea
Study ID: NCT05293470
Conditions
Interventions
Study Description
Brief Summary: This is a prospective, multicenter, open-label, non-comparative, non-interventional, observational study to assess te safety and effectiveness of Piqray in the real-world setting
Detailed Description: The observation duration will be up to 24 weeks after enrollment, which is sufficient to provide adequate information about the safety and effectiveness of Piqray. If the subject does not return for a follow-up visit or stops taking Piqray for any reason, all data collected until the date of the last contact of the subject will be used. Patients will be followed up (safety follow up) for 30 days afetr either 24 weeks-treatment or early withdrawal.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Novartis Investigative Site, Cheonan Si, Chungcheongnam Do, Korea, Republic of
Novartis Investigative Site, Deogyang Gu Goyang Si, Gyeonggi Do, Korea, Republic of
Novartis Investigative Site, Suwon si, Gyeonggi Do, Korea, Republic of
Novartis Investigative Site, Songpa-gu, Seoul, Korea, Republic of
Novartis Investigative Site, Busan, , Korea, Republic of
Novartis Investigative Site, Busan, , Korea, Republic of
Novartis Investigative Site, Daejeon, , Korea, Republic of
Novartis Investigative Site, Jeollanam, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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