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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04560452
Recruitment Status : Not yet recruiting
First Posted : September 23, 2020
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
This is a multi-centre, prospective, non-interventional study. The study will enrol about 1,500 Chinese cancer patients from around 30 sites who had received olaparib for at least one dose before study enrolment in real world practices in approved tumor types. Patient's treating physician is in charge of prescribing (including dose-adjusting or interruption) or discontinuation of olaparib.

Condition or disease
Ovarian Cancer

Detailed Description:

The study will recruit about 1,500 Chinese cancer patients from around 30 sites who received at least one dose of olaparib treatment before study enrolment in real world practice in approved tumor types.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 8 months after enrolment if treatment continues.

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 adverse events of special interest [AESIs]).

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Multi-Centre, Prospective, Non-Interventional Study to Intensively Monitor the Safety of Olaparib in Clinical Practice Among Chinese Patients
Estimated Study Start Date : November 16, 2020
Estimated Primary Completion Date : February 15, 2024
Estimated Study Completion Date : February 15, 2024

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Number and percentage of patients with AEs as well as number of AE events as assessed by CTCAEv4.0 [ Time Frame: from the time of signature of informed consent, throughout the treatment period and until the end of study follow-up (30 days after discontinuation of olaparib treatment, or 8 months after study enrolment, whichever comes earlier). ]
    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 adverse events of special interest [AESIs]). AESI for olaparib are the important potential risks of MDS/AML, new primary malignancy (other than MDS/AML) and pneumonitis.


Secondary Outcome Measures :
  1. Incidence of all AEs and incidence of AESIs for special populations [ Time Frame: from the time of signature of informed consent, throughout the treatment period and until the end of study follow-up (30 days after discontinuation of olaparib treatment, or 8 months after study enrolment, whichever comes earlier) ]
    Special populations includes patients with hepatic impairment or renal impairment, elderly patients with age > 65 years old



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study will recruit about 1,500 Chinese cancer patients from around 30 sites who received at least one dose of olaparib treatment before study enrolment in real world practice in approved tumor types.
Criteria

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
  • At least take one tablet of olaparib before enrolment

Exclusion Criteria:

• Enrolment in this study before or other ongoing studies, which prohibit any participation in this non-interventional study judged by investigator.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04560452


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Zhongqliu Lin Sun Yat-sen Memorial Hospital,Sun Yat-sen University
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04560452    
Other Study ID Numbers: D0817R00011
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No