Clinical trial · Observational
Efficacy and Adverse Effects of Olaparib in Ovarian Cancer.
The Efficacy and Adverse Effects of Olaparib in Ovarian Cancer: a Prospective Real-world Product Registration Study.
- 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)
Ovarian cancer is the second fatal gynecological cancer. More than 70% of ovarian cancer patients are diagnosed as advanced. Olaparib is the first oral poly adenosine diphosphate-ribose polymerase inhibitor (PAPPi) approved by the U.S. Drug Administration (FDA) in December 2014. It can be used as a maintenance treatment for adult patients with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer after platinum-containing chemotherapy has achieved complete or partial remission. At present, most studies based on olaparib are randomized controlled trials (RCTs). Because RCTs often have strict inclusion and exclusion criteria and they are implemented in a highly standardized environment. Its internal validity is high, but the research results may not be able to be extrapolated to practice. This study is a prospective real world study. In this study, based on the modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), we evaluate the use of olaparib in patients with ovarian cancer, fallopian tube cancer, and primary peritoneal cancer in the progression-free survival (PFS), overall survival (OS), and objective control rate (ORR), etc. At the same time, the safety and tolerability of olaparib and the impact on the quality of life of patients are evaluated. Finally, we analyze the results as a supplement to the conclusions of randomized controlled trials to provide better guidance for patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Progression-free survival (PFS)
- timeFrame
- 24 months
- description
- PFS is defined as the time from the first day of olaparib administration to disease progression (defined as objective radiological disease progression using modified Recist version 1.1 or clinical progression) or death.
- measure
- Adverse event(AE)
- timeFrame
- 24 months
- description
- Adverse Event (AE) refers to all the adverse medical events that occur after the subject receives the experimental drug. It can be manifested as symptoms and signs, diseases or abnormal laboratory tests, but it may not be causally related to the experimental drug.
Secondary outcomes (3)
- measure
- Overall survival (OS)
- timeFrame
- 60 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: 1. Patients with primary ovarian cancer, fallopian tube cancer, or peritoneal cancer confirmed by histology. 2. Patients who are taking olaparib. 3. Patients should voluntarily participate in the trial and provide signed informed consent. Exclusion Criteria: 1\) Patients who are not currently taking olaparib treatment.
References
Publications (0)
Data not yet available