Ovarian CancerNCT04560452
Drug Intensive Monitoring Study of Olaparib in Clinical Practice Among Chinese Patients
An observational study of Ovarian Cancer and Prostate Cancer, run by AstraZeneca at 37 sites in China.
Trial summary
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) . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ovarian Cancer, Prostate Cancer
- Type of treatment
- Pill or oral medicine
- How many people
- 1,018 participants
- Where
- 37 sitesChina
- Study dates
- 15 Mar 2021to 5 Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will recruit about 1000Chinese cancer patients from around 56 sites in real world practice in approved tumor types.
Who may be able to join
- 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
Who cannot join
- In other ongoing studies, which prohibit any participation in this non-interventional study judged by investigator.
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
China37 sites
Research Site
Anhui
Research Site
Beijing
Research Site
Changsha
Research Site
Chengdu
Research Site
Chongqing
Research Site
Dongguan
Research Site
Foshan
Research Site
Fujian
Research Site
Guangdong
Research Site
Guangzho
Research Site
Guangzhou
Research Site
Guizhou
Research Site
Hangzhou
Research Site
He'nan
Research Site
Hebei
Research Site
Heilongjiang
Research Site
Henan
Research Site
Huizhou
Research Site
Jiangsu
Research Site
Jiangxi
Research Site
Jilin City
Research Site
Jinghou
Research Site
Liaoning
Research Site
Luzhou
Research Site
Nanjing
Research Site
Nantong
Research Site
Ningbo
Research Site
Shandong
Research Site
Shanghai
Research Site
Shenyang
Research Site
Sichuan
Research Site
Taiyuan
Research Site
Tianjin
Research Site
Yichang
Research Site
Yunan
Research Site
Zhejiang
Research Site
Zhengzhou
About this study
Official title: A Multi-Centre, Prospective, Non-Interventional Study to Intensively Monitor the Safety of Olaparib in Clinical Practice Among Chinese Patients.
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.
Read the detailed description
The study will enrol about 1,000 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.
The recruited patients will be followed up according to standard clinical practice. They will be tracked up to 30 days after discontinuation of olaparib treatment, or 6 months for Cohort OC, 12 months for Cohort PC after enrolment.Every OC patient will be followed maximum of 6 months after enrolment as Olaparib AEs most occur in first 6m and PC patient will be followed maximum of 12 months to observe 1-year PFS. Any adverse events (AEs) that are ongoing at the patient's last visit in the study must be followed up by the investigator for as long as medically indicated, but without further recording in the electronic case report form (eCRF).
- Conditions
- Ovarian Cancer, Prostate Cancer
- Keywords
- OC and PC
- Medical subject headings
- Ovarian Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prostate cancer | according to the doctor's decision, have prescribed and agreed to start taking at least one dose of Olaparib | |
| Ovarian cancer | At least take one tablet of olaparib before enrolment for OC cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of patients with AEs as well as number of AE events as assessed by CTCAE
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.
Measured: 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.
Secondary outcomes (5)
Number and percentage of patients with AEs as well as number of AE events as assessed by CTCAE
To describe the safety and tolerability of olaparib in special populations (including patients with hepatic impairment or renal impairment, elderly patients with age > 65 years old) in Chinese patients by assessing the incidence, seriousness, causality, severity and action taken (interruption/dose reduction/discontinuation) of all AEs (including AESIs) among enrolled special populations. 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 for special populations.
Measured: from the time of signature of informed consent, throughout the treatment period and until the end of study follow-up in special populations, up to 6 months for Cohort OC, 12 months for Cohort PC after enrolment.
Progression-free survival(PFS) for PC cohort
PFS will be measured as the date of treatment initiation, until investigator-reported progression or death due to any cause, whichever occurs first for PC cohort.
Measured: From the date of treatment initiation, until investigator-reported progression or death, up to 12 months.
PFS rate at one year for PC cohort
PFS rate at one year is defined as the proportion of patients who are alive and progression free at 12 months after the start of treatment for PC cohort.
Measured: From the date of treatment initiation, until investigator-reported progression or death, up to 12 months.
Time to treatment discontinuation(TTTD) for PC cohort
TTTD will be measured as the date of treatment initiation, until the earlier of the date of treatment discontinuation or death for PC cohort.
Measured: From the date of treatment initiation, until the earlier of the date of treatment discontinuation or death, up to 12 months.
Number and percentage of patients with different treatment pattern for PC cohort
Number and percentage of patients with different treatment pattern,which will be classified by concomitant medications and procedures including surgery, radiation therapy, chemotherapy and hormone therapy (including castration therapy and anti-androgen therapy) for PC cohort.
Measured: From the time of signature of informed consent, throughout the treatment period and until the end of study follow-up, up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start15 Mar 2021
- Primary completion5 Sep 2025
- Study completion5 Sep 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
- 1,018 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhongqiu Lin, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560452
- Sponsor's protocol ID
- D0817R00011
- Status last verified
- Jul 2026
- First submitted
- 7 Sep 2020
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Prospective, Non-Interventional Study to Intensively Monitor the Safety of Olaparib in Clinical Practice Among Chinese Patients.
- ClinicalTrials.gov ID
- NCT04560452
- Acronym / sponsor ID
- D0817R00011
- Conditions
- Ovarian Cancer, Prostate Cancer
- Keywords
- OC and PC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,018 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 5 Sep 2025 (actual)
- First posted
- 23 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.
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.
Detailed description
The study will enrol about 1,000 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.
The recruited patients will be followed up according to standard clinical practice. They will be tracked up to 30 days after discontinuation of olaparib treatment, or 6 months for Cohort OC, 12 months for Cohort PC after enrolment.Every OC patient will be followed maximum of 6 months after enrolment as Olaparib AEs most occur in first 6m and PC patient will be followed maximum of 12 months to observe 1-year PFS. Any adverse events (AEs) that are ongoing at the patient's last visit in the study must be followed up by the investigator for as long as medically indicated, but without further recording in the electronic case report form (eCRF).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostate cancer | – | –according to the doctor's decision, have prescribed and agreed to start taking at least one dose of Olaparib |
| Ovarian cancer | – | –At least take one tablet of olaparib before enrolment for OC cohort |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will recruit about 1000Chinese cancer patients from around 56 sites in real world practice in approved tumor types.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- In other ongoing studies, which prohibit any participation in this non-interventional study judged by investigator.
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
Number and percentage of patients with AEs as well as number of AE events as assessed by CTCAE
Time frame: 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.
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.
5 secondary outcomes
Number and percentage of patients with AEs as well as number of AE events as assessed by CTCAE
Time frame: from the time of signature of informed consent, throughout the treatment period and until the end of study follow-up in special populations, up to 6 months for Cohort OC, 12 months for Cohort PC after enrolment.
Progression-free survival(PFS) for PC cohort
Time frame: From the date of treatment initiation, until investigator-reported progression or death, up to 12 months.
PFS rate at one year for PC cohort
Time frame: From the date of treatment initiation, until investigator-reported progression or death, up to 12 months.
Time to treatment discontinuation(TTTD) for PC cohort
Time frame: From the date of treatment initiation, until the earlier of the date of treatment discontinuation or death, up to 12 months.
Number and percentage of patients with different treatment pattern for PC cohort
Time frame: From the time of signature of informed consent, throughout the treatment period and until the end of study follow-up, up to 12 months.
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 8 Jul 2026.
- Redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Zhongqiu Lin principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
37 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 Prostate Cancer, run by AstraZeneca at 37 sites in China.
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 5 inclusion and 1 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 8 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 37 sites in China. 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?
Number and percentage of patients with AEs as well as number of AE events as assessed by CTCAE (time frame: 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.). 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 8 Jul 2026.