'OLAP' (OLAparib Regulatory Post-marketing Surveillance)

Breast Cancer Clinical Trial

— OLAP  

Official title:

Lynparza Tablet (Olaparib) Regulatory Post-Marketing Surveillance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04553926
• Other study ID #: D0817R00010
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objectives of this study are to assess safety and effectiveness of Lynparza tablet (olaparib, hereinafter "the study drug") in a real world setting in patients who are prescribed with the study drug according to the approved indications in South Korea

Description:

Primary Objective: To assess the safety of the study drug for patients prescribed with the study drug under the approved indications in South Korea Secondary Objective: To assess effectiveness of the study drug for patients prescribed with the study drug under the approved indication in South Korea Exploratory Objective: To assess effectiveness of the study drug for ovarian cancer patients diagnosed as Homologous Recombination Deficiency (HRD) positive via locally available validated HRD test and prescribed with the study drug under the approved indication in South Korea

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 150 Years

Eligibility

Inclusion Criteria:

1. Eligible for the study drug treatment according to the approved label in South Korea

2. Provision of signed and dated written informed consent by the patient or legally acceptable representative

Exclusion Criteria:

1. History of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug

2. Prior exposure to any Polyadenosine 5'diphosphoribose polymerase (PARP) inhibitors, including the study drug

3. Pregnant and/or breast feeding

4. Current participation in any interventional trial

5. Other off-label indications according to the approved label

Related Conditions & MeSH terms

• Breast Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Prostate Cancer

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Busan
Korea, Republic of	Research Site	Busan
Korea, Republic of	Research Site	Busan
Korea, Republic of	Research Site	Busan
Korea, Republic of	Research Site	Cheongju
Korea, Republic of	Research Site	Cheongju
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Daejeon
Korea, Republic of	Research Site	Goyang
Korea, Republic of	Research Site	Incheon
Korea, Republic of	Research Site	Seongnam
Korea, Republic of	Research Site	Seongnam
Korea, Republic of	Research Site	Seongnam
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suwon
Korea, Republic of	Research Site	Uijeongbu
Korea, Republic of	Research Site	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	1-year real-world Progression free survival (rwPFS)	for the exploratory objective, "In this PMS, the secondary/pre-specified endpoint is not just PFS, but real-world PFS (rwPFS). That means the sponsor cannot claim investigator/patients to visit hospital for study assessment purposes.; We, study sponsor, can only assess and record patient's disease progression status when patients visit hospital for their original follow-up. That's why we need further +50% duration for assessing rwPFS.	For about 18 months since the first dose of the study drug
Primary	Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions(ADRs), serious ADRs (SADRs), unexpected AEs/ADRs)		For about 1 year since the first dose of the study drug
Secondary	6-month real-world Progression free survival (rwPFS)	In this PMS, the secondary/pre-specified endpoint is not just PFS, but real-world PFS (rwPFS). That means the sponsor cannot claim investigator/patients to visit hospital for study assessment purposes.; We, study sponsor, can only assess and record patient's disease progression status when patients visit hospital for their original follow-up. That's why we need further +50% duration for assessing rwPFS.	For about 1 year since the first dose of the study drug