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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective Cohort | Patients with newly diagnosed AOC BRCAwt with known HRD status who have been prescribed 1L olaparib maintenance treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| None (Observational Study) | Other | Not Applicable since observational study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Index date - first olaparib prescription (Jan 2017 to Dec 2021) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Jan 2017 to Jun 2023 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with newly diagnosed AOC BRCAwt with available HRD status who have been prescribed 1L olaparib maintenance treatment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Tampa | Florida | 33606 | United States | ||
| Research Site |
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| Label | URL |
|---|---|
| CSR Synopsis\_Redacted | View source |
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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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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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| 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. |
| 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. | Jan 2017 to Jun 2023 |
| Shreveport |
| Louisiana |
| 71103 |
| United States |
| Research Site | Annapolis | Maryland | 21401 | United States |
| Research Site | Baltimore | Maryland | 21287 | United States |
| Research Site | New York | New York | 10032 | United States |
| Research Site | Charlotte | North Carolina | 28204 | United States |
| Research Site | Madison | Wisconsin | 53792 | United States |
| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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