Advanced Ovarian CancerFLAMENCT05775549
A Study to Characterize the Outcomes of Olaparib Maintenance Monotherapy in Newly Diagnosed BRCAwt Ovarian Cancer
An observational study of Advanced Ovarian Cancer, run by AstraZeneca at 7 sites in United States.
Trial summary
This study will collect the data from existing patient medical records at US cancer centers. The study will include patients with BRCAwt ovarian cancer who have been prescribed first line (1L) olaparib maintenance treatment. Read more about this study
- Who is it for?
- Ages 18 to 130 years, women only
- Conditions the study is for
- Advanced Ovarian Cancer
- What is being tested?
- None (Observational Study)
- How many people
- 24 participants
- Where
- 7 sitesUnited States
- Study dates
- 10 Jul 2023to 27 Oct 2023
- 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 18 to 130 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosed AOC BRCAwt with available HRD status who have been prescribed 1L olaparib maintenance treatment.
Who may be able to join
- Female adult, age ≥ 18 years
- BRCAwt AOC diagnosed with any approved BRCA test
- Has documented HRD status based on available test results
- Received 1L olaparib maintenance monotherapy following platinum chemotherapy
- Patients must have been treated with platinum-based chemotherapy at first-line
Who cannot join
- Received another poly adenosine diphosphate ribose polymerase (PARP) inhibitor or bevacizumab before or while prescribed olaparib
- Participation in an interventional clinical study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Research Site
Annapolis, Maryland, 21401
Research Site
Baltimore, Maryland, 21287
Research Site
Charlotte, North Carolina, 28204
Research Site
Madison, Wisconsin, 53792
Research Site
New York, New York, 10032
Research Site
Shreveport, Louisiana, 71103
Research Site
Tampa, Florida, 33606
About this study
Official title: FLAME - First Line olAparib Maintenance bEyond BRCA An Observational Cohort Study to Characterize the Outcomes of Olaparib Maintenance Monotherapy Beyond BRCA Mutant Status in Newly Diagnosed Advanced Ovarian Cancer
This study will collect the data from existing patient medical records at US cancer centers. The study will include patients with BRCAwt ovarian cancer who have been prescribed first line (1L) olaparib maintenance treatment.
Read the detailed description
This is a United States (US) based multicenter, retrospective, observational cohort study with data abstracted from patient medical records.
In this observational study, it is planned to include approximately 150 US female patients with newly diagnosed advanced ovarian cancer (AOC) who were tumor biomarker tested between first diagnosis with AOC and first prescription of 1L olaparib maintenance monotherapy as tumor breast cancer gene wild type (BRCAwt) with a known homologous recombination deficiency (HRD) status.
This retrospective cohort study will include patients with first olaparib prescription between Jan 2017 and Dec 2021. All data collection will be retrospective. Data will be collected from the date of first olaparib prescription (index date) with a follow-up period of at least 18 months post index date.
- Conditions
- Advanced Ovarian Cancer
- Being tested
- None (Observational Study)
- Keywords
- Real-world evidence, Homologous recombination deficiency, breast cancer gene, breast cancer gene mutated, breast cancer gene wild type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None (Observational Study)Other
Also called Observational Study
Not Applicable since observational study
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Cohort | Patients with newly diagnosed AOC BRCAwt with known HRD status who have been prescribed 1L olaparib maintenance treatment. Receives: Other: None (Observational Study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and Demographics characteristics
Clinical and Demographic characteristics including disease/FIGO stage, histology and tumor grade at initial Ovarian Cancer diagnosis, cancer antigen 125 (CA-125) level, Eastern Cooperative Oncology Group (ECOG) or other performance status, number and type of chemotherapy cycles, cytoreductive/debulking surgery type and outcomes, and selected comorbidities at index date will be described.
Summary statistics will be used to describe the Demographics and clinical characteristics.
The outcome will be measured for HRD+ patients.
Measured: At Index date - first olaparib prescription (Jan 2017 to Dec 2021)
Secondary outcomes (3)
Real-world time to first subsequent treatment or death (rwTFST)
rwTFST is defined as the time from the index date (date of the first olaparib prescription) to the earliest of the date of death or commencement of first subsequent anticancer treatment.
The outcome will be measured for HRD+ patients.
Measured: Jan 2017 to Jun 2023
Real-world time to treatment discontinuation or death (rwTTD)
rwTTD is defined as the time from the index date to the earliest of the date of death or discontinuation of olaparib.
The outcome will be measured for HRD+ patients.
Measured: Jan 2017 to Jun 2023
Number of patients with clinical event of interest (CEI)
To summarize the real-world safety and tolerability profile based on pre-specified CEIs of 1L olaparib maintenance monotherapy in BRCAwt newly diagnosed AOC patients regardless of HRD status.
Measured: Jan 2017 to Jun 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start10 Jul 2023
- Primary completion27 Oct 2023
- Study completion27 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775549
- Sponsor's protocol ID
- D0818R00008
- Acronym
- FLAME
- Status last verified
- Sep 2024
- First submitted
- 8 Mar 2023
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FLAME - First Line olAparib Maintenance bEyond BRCA An Observational Cohort Study to Characterize the Outcomes of Olaparib Maintenance Monotherapy Beyond BRCA Mutant Status in Newly Diagnosed Advanced Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05775549
- Acronym / sponsor ID
- FLAME / D0818R00008
- Conditions
- Advanced Ovarian Cancer
- Keywords
- Real-world evidence, Homologous recombination deficiency, breast cancer gene, breast cancer gene mutated, breast cancer gene wild type
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 27 Oct 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 20 Mar 2023 (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.
This study will collect the data from existing patient medical records at US cancer centers. The study will include patients with BRCAwt ovarian cancer who have been prescribed first line (1L) olaparib maintenance treatment.
Detailed description
This is a United States (US) based multicenter, retrospective, observational cohort study with data abstracted from patient medical records.
In this observational study, it is planned to include approximately 150 US female patients with newly diagnosed advanced ovarian cancer (AOC) who were tumor biomarker tested between first diagnosis with AOC and first prescription of 1L olaparib maintenance monotherapy as tumor breast cancer gene wild type (BRCAwt) with a known homologous recombination deficiency (HRD) status.
This retrospective cohort study will include patients with first olaparib prescription between Jan 2017 and Dec 2021. All data collection will be retrospective. Data will be collected from the date of first olaparib prescription (index date) with a follow-up period of at least 18 months post index date.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort | – | Other: None (Observational Study)Patients with newly diagnosed AOC BRCAwt with known HRD status who have been prescribed 1L olaparib maintenance treatment. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed AOC BRCAwt with available HRD status who have been prescribed 1L olaparib maintenance treatment.
Key inclusion criteria (5 listed)
- Female adult, age ≥ 18 years
- BRCAwt AOC diagnosed with any approved BRCA test
- Has documented HRD status based on available test results
- Received 1L olaparib maintenance monotherapy following platinum chemotherapy
- Patients must have been treated with platinum-based chemotherapy at first-line
Key exclusion criteria (2 listed)
- Received another poly adenosine diphosphate ribose polymerase (PARP) inhibitor or bevacizumab before or while prescribed olaparib
- Participation in an interventional clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None (Observational Study)Also: Observational StudyNot Applicable since observational study | Other | Retrospective Cohort |
Primary outcome
Clinical and Demographics characteristics
Time frame: At Index date - first olaparib prescription (Jan 2017 to Dec 2021)
Clinical and Demographic characteristics including disease/FIGO stage, histology and tumor grade at initial Ovarian Cancer diagnosis, cancer antigen 125 (CA-125) level, Eastern Cooperative Oncology Group (ECOG) or other performance status, number and type of chemotherapy cycles, cytoreductive/debulking surgery type and outcomes, and selected comorbidities at index date will be described. Summary statistics will be used to describe the Demographics and clinical characteristics. The outcome will be measured for HRD+ patients.
3 secondary outcomes
Real-world time to first subsequent treatment or death (rwTFST)
Time frame: Jan 2017 to Jun 2023
Real-world time to treatment discontinuation or death (rwTTD)
Time frame: Jan 2017 to Jun 2023
Number of patients with clinical event of interest (CEI)
Time frame: Jan 2017 to Jun 2023
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 20 Sep 2024.
- CSR Synopsis\_RedactedLink 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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Ovarian Cancer, run by AstraZeneca at 7 sites in United States.
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 5 inclusion and 2 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 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Clinical and Demographics characteristics (time frame: At Index date - first olaparib prescription (Jan 2017 to Dec 2021)). 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 20 Sep 2024.