Assessing the safety and effectiveness of Lynparza in real-world patients
Lynparza Tablet (Olaparib) Regulatory Post-Marketing Surveillance
This study is testing how safe and effective the Lynparza tablet is for real patients with different types of cancer, including ovarian, breast, prostate, and pancreatic cancers, in South Korea.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 19 Years to 150 Years |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 10 sites (Busan and 9 other locations) |
| Trial ID | NCT04553926 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and effectiveness of the Lynparza tablet (olaparib) in patients prescribed the drug for approved indications in South Korea. The primary objective focuses on assessing safety, while secondary objectives include evaluating effectiveness across various cancer types such as ovarian, breast, prostate, and pancreatic cancers. Additionally, the study will explore the effectiveness of Lynparza specifically in ovarian cancer patients who are Homologous Recombination Deficiency (HRD) positive. The study will gather data from real-world settings to provide insights into the drug's performance outside of controlled clinical environments.
Who should consider this trial
Good fit: Ideal candidates include patients in South Korea who are eligible for Lynparza treatment according to the approved label.
Not a fit: Patients with a history of hypersensitivity to the study drug or similar drugs, or those currently participating in interventional trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the real-world safety and effectiveness of Lynparza, potentially improving treatment strategies for patients with specific cancers.
How similar studies have performed: Other studies assessing the effectiveness of olaparib in various cancer types have shown promising results, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Busan and 9 other locations
- Research Site — Busan, Korea, Republic of (Recruiting)
- Research Site — Daejeon, Korea, Republic of (Recruiting)
- Research Site — Gunpo, Korea, Republic of (Recruiting)
- Research Site — Hwaseong, Korea, Republic of (Recruiting)
- Research Site — Ilsan, Korea, Republic of (Recruiting)
- Research Site — Seoul, Korea, Republic of (Withdrawn)
- Research Site — Seoul, Korea, Republic of (Recruiting)
- Research Site — Seul, Korea, Republic of (Recruiting)
- Research Site — Suwon, Korea, Republic of (Recruiting)
- Research Site — Yongin, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.