Clinical trial · Observational
Drug Intensive Monitoring Study of Olaparib in Clinical Practice Among Chinese Patients
A Multi-Centre, Prospective, Non-Interventional Study to Intensively Monitor the Safety of Olaparib in Clinical Practice Among Chinese Patients.
- 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)
This is a multi-centre, prospective, non-interventional study. The study will enrol about 860 Chinese cancer patients from around 56 sites. For OC cohort, the subjects who had received olaparib for at least one dose before study enrolment in real world practices will be enrolled ( n=800) . For PC cohort, according to the doctor's decision, patients who have prescribed and agreed to start taking at least one dose of Olaparib will be enrolled ( n=60). Patient's treating physician is in charge of prescribing (including dose-adjusting or interruption) or discontinuation of olaparib.
Conditions
Conditions (2)
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 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Prostate cancer
- description
- according to the doctor's decision, have prescribed and agreed to start taking at least one dose of Olaparib
- label
- Ovarian cancer
- description
- At least take one tablet of olaparib before enrolment for OC cohort
Primary outcomes (1)
- measure
- Number and percentage of patients with AEs as well as number of AE events as assessed by CTCAE
- timeFrame
- from the time of signature of informed consent, throughout the treatment period and until the end of study follow-up, up to 6 months for Cohort OC, 12 months for Cohort PC after enrolment.
- description
- The primary objective of this study is to describe the safety and tolerability of olaparib in Chinese patients by assessing the incidence, seriousness, causality, severity and action taken (interruption/dose reduction/discontinuation) of all AEs (including AESIs) among all enrolled patients (including OC and PC patients as a whole). The number and percentage of patients with AEs as well as number of AE events will be summarized by Medical Dictionary for Regulatory Activities (MedDRA) preferred terms and Common Terminology Criteria for Adverse Events (CTCAE) grade.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria * Provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures * Patients diagnosed as olaparib approved tumor types in China * Eligible for olaparib treatment per the judgement of the treating physician in clinical practice * For OC cohort: at least take one tablet of olaparib before enrolment * For PC cohort: according to the doctor's decision, have prescribed and agreed to start taking at least one dose of Olaparib Exclusion Criteria • In other ongoing studies, which prohibit any participation in this non-interventional study judged by investigator.
References
Publications (0)
Data not yet available