Drug Intensive Monitoring Study of Olaparib in Clinical Practice Among Chinese Patients

Study Overview
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Brief Summary
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This is a multi-centre, prospective, non-interventional study. 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=200). Patient's treating physician is in charge of prescribing (including dose-adjusting or interruption) or discontinuation of olaparib.

Detailed Description
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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=200). 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).

Official Title
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A Multi-Centre, Prospective, Non-Interventional Study to Intensively Monitor the Safety of Olaparib in Clinical Practice Among Chinese Patients.

Conditions
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Ovarian Cancer, Prostate Cancer

Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prostate cancer<br>according to the doctor's decision, have prescribed and agreed to start taking at least one dose of Olaparib | |
| Ovarian cancer<br>At least take one tablet of olaparib before enrolment for OC cohort | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | From the time of signature of informed consent, throughout the treatment period and until the end of study follow-up, up to 12 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OC and PC