Last updated: 03/11/2025 09:40:31
Clinical outcomes of poly (adenosine diphosphate) ribose polymerase (PARP) inhibitor monotherapies vs. bevacizumab monotherapy for advanced ovarian cancer
GSK study ID
214311
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: Real World Comparisons of Clinical Outcomes for PARP Inhibitor monotherapies and Bevacizumab Monotherapy in the First-Line Maintenance Setting of Advanced Ovarian Cancer
Trial description: This study will compare the characteristics and clinical outcomes of participants with advanced ovarian cancer, receiving PARP inhibitor monotherapies and bevacizumab monotherapy as first line (1L) maintenance therapy, using the Flatiron Health electronic healthcare record (EHR)-derived database.
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Phase 1: Demographic characteristics of participants
Timeframe: Up to 80 weeks
Phase 1: Clinical characteristics of participants
Timeframe: Up to 80 weeks
Phase 2: Time to treatment discontinuation (TTD) among participants receiving PARP inhibitor monotherapy
Timeframe: Up to 80 weeks
Phase 2: TTD among participants receiving bevacizumab monotherapy
Timeframe: Up to 80 weeks
Secondary outcomes:
Phase 2: Overall survival (OS) among participants receiving PARP inhibitor monotherapies and bevacizumab monotherapy
Timeframe: Up to 80 weeks
Phase 2: Time to next treatment (TTNT) among participants receiving PARP inhibitor monotherapies and bevacizumab monotherapy
Timeframe: Up to 80 weeks
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2023-26-05
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Ovarian Neoplasms
Product
bevacizumab
Collaborators
Not applicable
Study date(s)
November 2021 to May 2023
Type
Observational
Phase
4
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
Yes
- Initial ovarian cancer diagnosis date during the data availability period
- Stage III or IV ovarian cancer on the initial ovarian cancer diagnosis date (01-Jan-2016 to the last date of the data cut)
- Used a PARP inhibitor concurrently with 1L chemotherapy
- Started second line (2L) treatment within 2 months (60 days) of the last dose of platinum-based 1L chemotherapy
Inclusion and exclusion criteria
Inclusion criteria:
- Initial ovarian cancer diagnosis date during the data availability period
- Stage III or IV ovarian cancer on the initial ovarian cancer diagnosis date (01-Jan-2016 to the last date of the data cut)
- Aged greater than or equal to (>=) 18 years on the initial ovarian cancer diagnosis date
- Received platinum-based 1L chemotherapy (carboplatin, cisplatin, oxaliplatin) on or after the initial ovarian cancer diagnosis
- Received bevacizumab concurrently with 1L chemotherapy
- Received PARP inhibitor monotherapies or bevacizumab monotherapy based on Flatiron’s line of therapy algorithm.
Exclusion criteria:
- Used a PARP inhibitor concurrently with 1L chemotherapy
- Started second line (2L) treatment within 2 months (60 days) of the last dose of platinum-based 1L chemotherapy
- Were pregnant any time during the data availability period.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Other
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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