Ovarian CancerNCT03505307
Lynparza Ovarian Cancer Clinical Experience Investigation (All Case Investigation)
An observational study of Ovarian Cancer, run by AstraZeneca.
Trial summary
[Objectives] Objectives include following to capture safety and efficacy of LYNPARZA in actual clinical use. 1. ADR development in actual clinical use 2. Factors which may affect safety and efficacy 3. ADRs not expected from "Precautions for Use" Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 846 participants
- Where
- No sites listed yet
- Study dates
- 21 May 2018to 7 Dec 2020
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated with LYNPARZA for ovarian cancer which is the indication of the drug
Who may be able to join
- Maintenance treatment for patients with recurrent ovarian cancer, who are sensitive to platinum based chemotherapy
Who cannot join
- -
About this study
Official title: Lynparza Tablets 100mg, 150mg Clinical Experience Investigation (All Case Investigation) in Patients With Platinum-sensitive Relapsed Ovarian Cancer
[Objectives] Objectives include following to capture safety and efficacy of LYNPARZA in actual clinical use.
- ADR development in actual clinical use
- Factors which may affect safety and efficacy
- ADRs not expected from "Precautions for Use"
Read the detailed description
The objective of the Clinical Experience Investigation (CEI) is to collect following data to characterise safety and efficacy of LYMPARZA Tablets 100mg and 150mg (LYMPARZA) in usual post-marketing use.
- Development of adverse drug reactions (ADRs)
- Factors which may affect safety and efficacy of LYMPARZA
- Development of adverse drug reactions (ADRs) unexpected from "Precautions for Use" of the LYMPARZA JPI
- Conditions
- Ovarian Cancer
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ADRs regarding Bone marrow depression, ILD, new primary malignancies, Embryo-foetal toxicity and exposure in patient with renal impairment
To be calculated incidence of ADRs related to LYMPARZA during the observation period regarding Bone marrow depression, ILD, new primary malignancies, Embryo-foetal toxicity and exposure in patient with renal impairment
Measured: from baseline to 1 year
Factors which may impact incidence of ADRs related to LYMPARZA during the observation period, analysed by patient demographic characteristics
Factors which may impact incidence of ADRs, analysed by patient demographic characteristic(past medical history, and concomitant disease etc)
Measured: from baseline to 1 year
Incidence of ADRs not expected from "Precautions for Use" of LYNPARZA JPI
To be calculated incidence of ADRs related to LYMPARZA during the observation period not expected from "Precautions for Use" of LYNPARZA JPI
Measured: from baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start21 May 2018
- Primary completion7 Dec 2020
- Study completion7 Dec 2020
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 846 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toshimitsu Tokimoto, Study director, AstraZeneca KK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505307
- Sponsor's protocol ID
- D0816C00019
- Status last verified
- May 2022
- First submitted
- 10 Apr 2018
- Last updated
- 1 Jun 2022
- Results posted
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lynparza Tablets 100mg, 150mg Clinical Experience Investigation (All Case Investigation) in Patients With Platinum-sensitive Relapsed Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03505307
- Acronym / sponsor ID
- D0816C00019
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 846 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 21 May 2018 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 23 Apr 2018 (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.
[Objectives] Objectives include following to capture safety and efficacy of LYNPARZA in actual clinical use.
- ADR development in actual clinical use
- Factors which may affect safety and efficacy
- ADRs not expected from "Precautions for Use"
Detailed description
The objective of the Clinical Experience Investigation (CEI) is to collect following data to characterise safety and efficacy of LYMPARZA Tablets 100mg and 150mg (LYMPARZA) in usual post-marketing use.
- Development of adverse drug reactions (ADRs)
- Factors which may affect safety and efficacy of LYMPARZA
- Development of adverse drug reactions (ADRs) unexpected from "Precautions for Use" of the LYMPARZA JPI
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated with LYNPARZA for ovarian cancer which is the indication of the drug
Key inclusion criteria (1 listed)
- Maintenance treatment for patients with recurrent ovarian cancer, who are sensitive to platinum based chemotherapy
Key exclusion criteria (1 listed)
- -
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
Incidence of ADRs regarding Bone marrow depression, ILD, new primary malignancies, Embryo-foetal toxicity and exposure in patient with renal impairment
Time frame: from baseline to 1 year
To be calculated incidence of ADRs related to LYMPARZA during the observation period regarding Bone marrow depression, ILD, new primary malignancies, Embryo-foetal toxicity and exposure in patient with renal impairment
Factors which may impact incidence of ADRs related to LYMPARZA during the observation period, analysed by patient demographic characteristics
Time frame: from baseline to 1 year
Factors which may impact incidence of ADRs, analysed by patient demographic characteristic(past medical history, and concomitant disease etc)
Incidence of ADRs not expected from "Precautions for Use" of LYNPARZA JPI
Time frame: from baseline to 1 year
To be calculated incidence of ADRs related to LYMPARZA during the observation period not expected from "Precautions for Use" of LYNPARZA JPI
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 1 Jun 2022.
- Related InfoLink provided by the sponsor.
- redacted protocolLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
Toshimitsu Tokimoto study director
AstraZeneca KK
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by AstraZeneca.
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 1 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 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of ADRs regarding Bone marrow depression, ILD, new primary malignancies, Embryo-foetal toxicity and exposure in patient with renal impairment (time frame: from baseline to 1 year). The study lists 3 primary outcomes in all. 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 1 Jun 2022.