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

April 24, 2024 updated by: AstraZeneca

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 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.

Study Overview

Status

Recruiting

Conditions

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=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).

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Anhui, China
        • Completed
        • Research Site
      • Beijing, China
        • Recruiting
        • Research Site
      • Beijing, China
        • Completed
        • Research Site
      • Changsha, China
        • Recruiting
        • Research Site
      • Chengdu, China
        • Recruiting
        • Research Site
      • Chengdu, China
        • Completed
        • Research Site
      • Chongqing, China
        • Recruiting
        • Research Site
      • Dalian, China
        • Active, not recruiting
        • Research Site
      • Dongguan, China
        • Recruiting
        • Research Site
      • Foshan, China
        • Recruiting
        • Research Site
      • Guangzho, China
        • Recruiting
        • Research Site
      • Guangzhou, China
        • Recruiting
        • Research Site
      • Guangzhou, China
        • Completed
        • Research Site
      • Guizhou, China
        • Completed
        • Research Site
      • Hangzhou, China
        • Recruiting
        • Research Site
      • Hangzhou, China
        • Completed
        • Research Site
      • Harbin, China
        • Completed
        • Research Site
      • Henan, China
        • Recruiting
        • Research Site
      • Henan, China
        • Completed
        • Research Site
      • Huizhou, China
        • Recruiting
        • Research Site
      • JingHou, China
        • Recruiting
        • Research Site
      • Langfang, China
        • Completed
        • Research Site
      • Luzhou, China
        • Recruiting
        • Research Site
      • Nanchang, China
        • Completed
        • Research Site
      • Nanjing, China
        • Recruiting
        • Research Site
      • Nanjing, China
        • Completed
        • Research Site
      • Nantong, China
        • Recruiting
        • Research Site
      • Nantong, China
        • Active, not recruiting
        • Research Site
      • Ningbo, China
        • Recruiting
        • Research Site
      • Shandong, China
        • Recruiting
        • Research Site
      • Shandong, China
        • Completed
        • Research Site
      • Shanghai, China
        • Recruiting
        • Research Site
      • Shanghai, China
        • Active, not recruiting
        • Research Site
      • Shanghai, China
        • Completed
        • Research Site
      • Shantou, China
        • Completed
        • Research Site
      • Shenyang, China
        • Recruiting
        • Research Site
      • Shenyang, China
        • Completed
        • Research Site
      • Shenzhen, China
        • Completed
        • Research Site
      • Shijazhuang, China
        • Completed
        • Research Site
      • Taiyuan, China
        • Recruiting
        • Research Site
      • Taiyuan, China
        • Active, not recruiting
        • Research Site
      • Tianjin, China
        • Recruiting
        • Research Site
      • Tianjin, China
        • Completed
        • Research Site
      • Xi'an, China
        • Withdrawn
        • Research Site
      • Xiamen, China
        • Completed
        • Research Site
      • Yichang, China
        • Recruiting
        • Research Site
      • Yunnan, China
        • Completed
        • Research Site
      • Zhangjiagang, China
        • Completed
        • Research Site
      • Zhengzhou, China
        • Recruiting
        • Research Site
      • Zhengzhou, China
        • Completed
        • Research Site
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Research Site
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study will recruit about 1000Chinese cancer patients from around 56 sites in real world practice in approved tumor types.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

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
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.
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
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.
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
Time Frame: From the date of treatment initiation, until investigator-reported progression or death, up to 12 months.
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
Time Frame: From the date of treatment initiation, until investigator-reported progression or death, up to 12 months.
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
Time Frame: From the date of treatment initiation, until the earlier of the date of treatment discontinuation or death, up to 12 months.
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
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Zhongqiu Lin, Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2021

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

September 7, 2020

First Submitted That Met QC Criteria

September 17, 2020

First Posted (Actual)

September 23, 2020

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D0817R00011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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