Ovarian CancerOLAPNCT04553926
'OLAP' (OLAparib Regulatory Post-marketing Surveillance)
An observational study of Ovarian Cancer and Breast Cancer, run by AstraZeneca at 18 sites in South Korea.
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 Read more about this study
- Who is it for?
- Ages 19 to 150 years
- Conditions the study is for
- Ovarian Cancer, Breast Cancer, Prostate Cancer
- How many people
- 661 participants
- Where
- 18 sitesSouth Korea
- Study dates
- 1 Feb 2021to 11 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 150 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: On active study drug treatment according to the approved local label.
Who may be able to join
- Eligible for the study drug treatment according to the approved label in South Korea
- Provision of signed and dated written informed consent by the patient or legally acceptable representative
Who cannot join
- History of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug
- Prior exposure to any Polyadenosine 5'diphosphoribose polymerase (PARP) inhibitors, including the study drug
- Pregnant and/or breast feeding
- Current participation in any interventional trial
- Other off-label indications according to the approved label
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
South Korea18 sites
Research Site
Ansan
Research Site
Bucheon-si
Research Site
Busan
Research Site
Changwon
Research Site
Daegu
Research Site
Daejeon
Research Site
Goyang
Research Site
Gunpo
Research Site
Hwaseong
Research Site
Ilsan
Research Site
Incheon
Research Site
Jeonju
Research Site
Seongnam
Research Site
Seoul
Research Site
Suwon
Research Site
Uijeongbu-si
Research Site
Yangsan
Research Site
Yŏngin
About this study
Official title: Lynparza Tablet (Olaparib) Regulatory Post-Marketing Surveillance
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
Read the 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
- Conditions
- Ovarian Cancer, Breast Cancer, Prostate Cancer, Pancreatic Cancer
- Medical subject headings
- Ovarian Neoplasms, Breast Neoplasms, Prostatic Neoplasms, Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions(ADRs), serious ADRs (SADRs), unexpected AEs/ADRs)
Measured: For about 1 year since the first dose of the study drug
Secondary outcomes (1)
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.
Measured: For about 1 year since the first dose of the study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start1 Feb 2021
- Primary completion11 Jul 2025
- Study completion11 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 661 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553926
- Sponsor's protocol ID
- D0817R00010
- Acronym
- OLAP
- Status last verified
- Jul 2026
- First submitted
- 10 Sep 2020
- Last updated
- 23 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lynparza Tablet (Olaparib) Regulatory Post-Marketing Surveillance
- ClinicalTrials.gov ID
- NCT04553926
- Acronym / sponsor ID
- OLAP / D0817R00010
- Conditions
- Ovarian Cancer, Breast Cancer, Prostate Cancer, Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 661 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 11 Jul 2025 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 150 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- On active study drug treatment according to the approved local label.
Key inclusion criteria (2 listed)
- Eligible for the study drug treatment according to the approved label in South Korea
- Provision of signed and dated written informed consent by the patient or legally acceptable representative
Key exclusion criteria (5 listed)
- History of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug
- Prior exposure to any Polyadenosine 5'diphosphoribose polymerase (PARP) inhibitors, including the study drug
- Pregnant and/or breast feeding
- Current participation in any interventional trial
- Other off-label indications according to the approved label
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions(ADRs), serious ADRs (SADRs), unexpected AEs/ADRs)
Time frame: For about 1 year since the first dose of the study drug
1 secondary outcome
6-month real-world Progression free survival (rwPFS)
Time frame: For about 1 year since the first dose of the study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Redacted CSR synopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Breast Cancer, run by AstraZeneca at 18 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions(ADRs), serious ADRs (SADRs), unexpected AEs/ADRs) (time frame: For about 1 year since the first dose of the study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.