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Completed

NCT Number: NCT04560452

Drug Intensive Monitoring Study 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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Male Urogenital Diseases Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Anhui, China

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About this 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=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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2020
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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