Clinical trial NCT04532645: Olaparib Real-world Utilization and Clinical Outcomes in France, Italy, and the UK
Official title: A Pan-European Non-interventional, Retrospective Observational Cohort Study of Patients With BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer Treated With Olaparib Tablets in the First-line Maintenance Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovary Cancer
Keywords: Ovary cancer
Ovarian neoplasm
BRCA mutated advanced (FIGO stage III-IV) ovarian cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2020-08-31
Enrollment: 342
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: • Patients with BRCA mutated advanced (FIGO stage III-IV) ovarian cancer treated with olaparib in first-line maintenance setting

Brief summary: This is a retrospective observational medical records review study of BRCA mutated advanced (FIGO stage III-IV) ovarian cancer patients who received first dose maintenance olaparib in 1L setting in France, Italy and the UK. Physicians who treated ovarian cancer patients with olaparib in 1L setting will be requested to recruit patients to have their clinical data abstracted from their clinical records in line with local laws

Detailed description: Primary Objective(s)

1. To estimate progression-free survival (PFS) in patients with BRCA-mutated advanced ovarian cancer treated with olaparib tablets in real-world first line maintenance setting.
2. To describe olaparib treatment patterns (dosage; frequency of: dosage changes, dose interruptions, treatment cessation) in patients with BRCA-mutated advanced ovarian cancer treated in real-world first line maintenance setting.

Secondary Objective(s)

1. To estimate overall survival (OS) in patients with BRCA-mutated advanced ovarian cancer treated with olaparib tablets in real-world first line maintenance setting.
2. To describe reasons for olaparib dosage changes, dose interruptions and treatment cessation in patients with BRCA-mutated advanced ovarian cancer treated in real-world first line maintenance setting
3. To describe surgical and chemotherapy outcomes (PR/CR) in patients with BRCA-mutated advanced ovarian cancer before initiation of real-world first line maintenance olaparib tablets
4. To describe response rate (RR) to olaparib tablets in patients with BRCA-mutated ovarian cancer with partial response to real-world first line chemotherapy.
5. To describe treatment patterns and clinical outcomes in patients with BRCA-mutated advanced ovarian cancer who progressed during olaparib real-world first line maintenance therapy (including frequency of treatment interruptions, dosage reductions and treatment discontinuations and reasons associated with patterns)
6. To estimate second progression-free survival (PFS2) in patients with BRCA-mutated ovarian cancer who progress while on olaparib real-world first line maintenance therapy.
7. To describe healthcare resource utilisation in patients with BRCA-mutated advanced ovarian cancer treated with olaparib in real-world first line setting

Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed, histologically confirmed, advanced (FIGO stage III - IV) epithelial ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer who have completed first line platinum-based chemotherapy, in PR/CR and treated with at least one dose of olaparib in first line maintenance setting
* Patients aged ≥18 years old
* Ability and/or willingness to provide a signed informed consent form (where required)

Exclusion Criteria:

* Withdrawal of informed consent (where consent required)
* Concurrent participation in any clinical study with an investigational product at the time of olaparib initiation

Primary outcomes:
measure: Progression
timeFrame: 36 months
Secondary outcomes:
measure: Overall Survival
timeFrame: 36 months
Other outcomes:
Locations:
city: Avignon Cedex 9
country: France
facility: Research Site
city: Besancon
country: France
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Bourg-en-Bresse
country: France
facility: Research Site
city: Calais
country: France
facility: Research Site
city: Chambray-les-Tours
country: France
facility: Research Site
city: Epagny Metz-Tessy
country: France
facility: Research Site
city: Grenoble
country: France
facility: Research Site
city: Langon
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Nancy
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Pierre-Benite
country: France
facility: Research Site
city: Roubaix
country: France
facility: Research Site
city: Saint-Cloud
country: France
facility: Research Site
city: Saint-Gregoire
country: France
facility: Research Site
city: Suresnes
country: France
facility: Research Site
city: Tours
country: France
facility: Research Site
city: Villejuif
country: France
facility: Research Site
city: Acquaviva delle Fonti
country: Italy
facility: Research Site
city: Aviano
country: Italy
facility: Research Site
city: Bari
country: Italy
facility: Research Site
city: Bologna
country: Italy
facility: Research Site
city: Cagliari
country: Italy
facility: Research Site
city: Catania
country: Italy
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Modena
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Negrar
country: Italy
facility: Research Site
city: Parma
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
city: Ediburgh
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Guildford
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Maidstone
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Newcastle
country: United Kingdom
facility: Research Site
city: Northampton
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Portsmouth
country: United Kingdom
facility: Research Site
city: Swansea
country: United Kingdom
facility: Research Site
Study officials:
affiliation: University of Edinburgh
name: Charlie Gourley, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Domenica Lorusso, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Bergonie, France
name: Delphine Garbay, MD
role: PRINCIPAL_INVESTIGATOR
References: