Clinical trial · Observational
'OLAP' (OLAparib Regulatory Post-marketing Surveillance)
Lynparza Tablet (Olaparib) Regulatory Post-Marketing Surveillance
NCT04553926CI-TRIAL-00119111OLAPcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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 (1)
- measure
- 6-month real-world Progression free survival (rwPFS)
- timeFrame
- For about 1 year since the first dose of the study drug
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 150 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.