Clinical trial NCT04553926: 'OLAP' (OLAparib Regulatory Post-marketing Surveillance)
Official title: Lynparza Tablet (Olaparib) Regulatory Post-Marketing Surveillance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Breast Cancer
Prostate Cancer
Pancreatic Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2020-09-18
Enrollment: 600
Sex: ALL
Minimum age (years): 19
Maximum age (years): 150
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: On active study drug treatment according to the approved local label.

Brief 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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions(ADRs), serious ADRs (SADRs), unexpected AEs/ADRs)
timeFrame: For about 1 year since the first dose of the study drug
Secondary outcomes:
measure: 6-month real-world Progression free survival (rwPFS)
timeFrame: For about 1 year since the first dose of the study drug
Other outcomes:
measure: 1-year real-world Progression free survival (rwPFS)
timeFrame: For about 18 months since the first dose of the study drug
Locations:
city: Busan
country: Korea, Republic of
facility: Research Site
city: Daejeon
country: Korea, Republic of
facility: Research Site
city: Gunpo
country: Korea, Republic of
facility: Research Site
city: Hwaseong
country: Korea, Republic of
facility: Research Site
city: Ilsan
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seul
country: Korea, Republic of
facility: Research Site
city: Suwon
country: Korea, Republic of
facility: Research Site
city: Yongin
country: Korea, Republic of
facility: Research Site
Study officials:
References: