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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04553926
Other study ID # D0817R00010
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2021
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Is FDA regulated No
Health authority
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 December 31, 2024
Est. primary completion date December 31, 2024
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

Study Design


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
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