Last updated: 06/11/2025 12:30:39

Real World Comparisons of Clinical Outcomes for PARP inhibitor monotherapies and active surveillance in participants with advanced ovarian cancer

GSK study ID
214309
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Real World Comparisons of Clinical Outcomes for PARP inhibitor monotherapies and Active Surveillance in the First-Line Maintenance Setting of Advanced Ovarian Cancer
Trial description: This non-interventional study aims to compare the clinical outcomes between Poly adenosine diphosphate-ribose polymerase (PARP) inhibitor monotherapies and active surveillance using the Flatiron Health database in participants with advanced ovarian cancer.
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Real world progression free survival in PARP inhibitor monotherapies cohort

Timeframe: Up to 4 months

Real world progression free survival in active surveillance cohort

Timeframe: Up to 4 months

Overall survival in PARP inhibitor monotherapies cohort

Timeframe: Up to 4 months

Overall survival in active surveillance cohort

Timeframe: Up to 4 months

Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2022-05-10
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Ovarian Neoplasms
Product
Not applicable
Collaborators
Not applicable
Study date(s)
August 2022 to October 2022
Type
Observational
Phase
4

Participation criteria

Sex
Female
Age
18+ years
Accepts healthy volunteers
No
  • Participants with an ovarian cancer diagnosis, with the initial ovarian cancer diagnosis date during the data availability period (01-Jan-2016 to 28-Feb-2021 or until the last date of the data cut).
  • Stage III or IV ovarian cancer on the initial ovarian cancer diagnosis date.
  • Participants who have used a PARP inhibitors (PARPi) in the 1L treatment.
  • Participants who started 2L treatment within 2 months (60 days) of the last dose of platinum-based 1L chemotherapy.
Inclusion and exclusion criteria
Inclusion criteria:
  • Participants with an ovarian cancer diagnosis, with the initial ovarian cancer diagnosis date during the data availability period (01-Jan-2016 to 28-Feb-2021 or until the last date of the data cut).
  • Stage III or IV ovarian cancer on the initial ovarian cancer diagnosis date.
  • Participants who have received platinum-based 1L chemotherapy (carboplatin, cisplatin, oxaliplatin) on or after the initial ovarian cancer diagnosis.
  • Participants who have received the last dose of platinum-based 1L chemotherapy during the identification period (01-Jan-2017 to 28-Feb-2021 or until the last date of the data cut).
  • Participants with age greater than or equal to (>=)18 years on the initial ovarian cancer diagnosis date.
  • Participants who have received PARP inhibitor monotherapies or no treatment during the 4-month (120-day) treatment identification period after the last dose of platinum-based 1L chemotherapy. The end of the treatment identification period (120 days after the last dose of 1L platinum-based chemotherapy) will be defined as the index date.
Exclusion criteria:
  • Participants who have used a PARP inhibitors (PARPi) in the 1L treatment.
  • Participants who started 2L treatment within 2 months (60 days) of the last dose of platinum-based 1L chemotherapy.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Study report synopsis
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Study complete
Actual primary completion date
2022-05-10
Actual study completion date
2022-05-10

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website