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CompletedNCT03106987OReOUpdated Oct 7, 2022Results posted

A Study to Examine Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer.

A Phase 3 interventional study of Active Comparator: Olaparib tablets and Placebo in Epithelial Ovarian Cancer, sponsored by AstraZeneca. Completed at 82 sites in 11 countries. Open to female participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2022-10-07.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years to 130 Years
Sex
Female
01

Study summary

The OReO study will be a Phase IIIb, randomised, double-blind, placebo-controlled, multicentre study to assess the efficacy and tolerability of Olaparib retreatment, versus matching placebo, in non-mucinous epithelial ovarian cancer (EOC) patients (including patients with primary peritoneal and/or fallopian tube cancer)

Read the detailed description

The OReO study will investigate the efficacy and safety of Olaparib maintenance re-treatment in patients with relapsed non-mucinous EOC, who have had disease progression following maintenance therapy with a Polyadenosine 5'diphosphoribose [poly (ADP ribose)] polymerisation inhibitor (PARPi) and a complete or partial radiological response to subsequent treatment with platinum-based chemotherapy or may have no evidence of disease (if optimal cytoreductive surgery was conducted prior to chemotherapy), and no evidence of a rising CA-125. Patients will be enrolled on the basis of their breast cancer susceptibility gene (BRCA1, BRCA2) status into one of two cohorts (BRCA1/2 [+ve] and BRCA1/2 [-ve]). The BRCA1/2 (+ve) and BRCA1/2 (-ve) cohorts will be randomised separately. Within each cohort, patients will be randomised by prospective allocation in a 2:1 ratio (Olaparib: matching placebo).

02

Conditions studied

  • Epithelial Ovarian Cancer

Keywords

  • polymerisation inhibitor (PARPi)
  • PARPi re-treatment
  • BRCA1/2 (+ve)
  • BRCA1/2 (-ve)
  • Olaparib
  • ovarian cancer
  • progression free survival (PFS)
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 220 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 130 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Provision of informed consent prior to any study specific procedures
  • Female patients ≥18 years of age, with histologically diagnosed relapsed non-mucinous epithelial ovarian cancer (EOC) (including primary peritoneal and/or fallopian tube cancer) (Non-mucinous EOC includes patients with serous, endometrioid, and transitional cell tumours, and those with mixed histology where one of these subtypes is predominant (>50%). Inclusion of other subtypes should first be discussed with the Medical Monitor).
  • Documented BRCA1/2 status.
  • Patients must have received one prior PARPi therapy PARPi therapy includes any agent (including Olaparib) used in a maintenance setting For the BRCA1/2 (+ve) cohort, the duration of first PARPi exposure must have been ≥18 months following a first line of chemotherapy or ≥12 months following a second or subsequent line of chemotherapy For the BRCA1/2 (-ve) cohort, the duration of first PARPi exposure must have been ≥12 months following a first line of chemotherapy or ≥6 months following a second or subsequent line of chemotherapy For the last chemotherapy course immediately prior to randomisation on the study Patients must have received a platinum-based chemotherapy regimen (carboplatin, cisplatin or oxaliplatin) and have received at least 4 cycles of treatment Patients must be, in the opinion of the investigator, in response (partial or complete radiological response) or may have no evidence of disease (if optimal cytoreductive surgery was conducted prior to chemotherapy) and no evidence of a rising CA-125, as defined below, following completion of this chemotherapy course Pre-treatment CA-125 measurements must meet criterion specified below
  • If the first value is within upper limit of normal (ULN) the patient is eligible to be randomised and a second sample is not required
  • If the first value is greater than ULN a second assessment must be performed at least 7 days after the first. If the second assessment is ≥ 15% more than the first the patient is not eligible.

Patients must not have received bevacizumab during this course of treatment. Bevacizumab use as part of an earlier line of chemotherapy is permitted Patients must not have received any investigational agent during this course of treatment Patients must be randomised within 8 weeks of their last dose of chemotherapy (last dose is the day of the last infusion)

  • Patients must have normal organ and bone marrow function measured within 28 days of randomization.
  • Eastern Cooperative Oncology Group performance status 0-1
  • Patients must have a life expectancy ≥16 weeks.
  • Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1
  • At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for repeated assessment. or No measurable disease following a complete response to most recent chemotherapy (+/- surgery)
  • A formalin fixed, paraffin embedded (FFPE) tumour sample from the cancer of sufficient quantity and quality (as specified in the Covance Central Laboratory Services Manual) must be available for future central testing of tumour genetic status.
  • For inclusion in the optional biomarker research, patients must sign an informed consent for biomarker research.

Exclusion criteria

Exclusion criteria:

  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
  • Participation in another clinical study with an investigational product during the chemotherapy course immediately prior to randomisation.
  • Other malignancy within the last 5 years except the ones detailed in the exclusion criteria section of study protocol.
  • Resting electrocardiogram (ECG) with corrected QT interval (QTc) >470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome6. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative radiotherapy) within 3 weeks prior to study treatment.
  • Concomitant use of known strong cytochrome P450 (CYP) subfamily 3A (CYP3A) inhibitors or moderate CYP3A inhibitors.
  • Concomitant use of known strong or moderate CYP3A inducers.
  • Persistent toxicities (Common Terminology Criteria for Adverse Event [CTCAE] grade 2 or higher) caused by previous cancer therapy, excluding alopecia and stable Grade 2 peripheral neuropathy .
  • Patients with current or previous myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) or with features suggestive of MDS/AML.
  • Patients with symptomatic uncontrolled brain metastases.
  • Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
  • Patients with a known hypersensitivity to Olaparib or any of the excipients of the product.
  • Patients with a known active hepatitis (i.e..Hepatitis B or C).
  • Patient who have received a whole blood transfusion within 30 days prior to screening tests (packed red blood cells and platelet transfusions are acceptable).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
220 participants (actual)

Study arms

  • Experimental
    Active Comparator: Olaparib

    Olaparib 300mg tablets administered orally twice daily continuously.

    Drug: Active Comparator: Olaparib tablets

  • Placebo comparator
    Placebo Comparator: Placebo

    Matching placebo 300mg tablets administered orally twice daily continuously.

    Drug: Placebo

Interventions

  • DrugActive Comparator: Olaparib tablets

    Olaparib 300mg Olaparib tablets taken orally twice daily (except where this dose and formulation was previously not tolerated) until objective radiological disease progression as per RECIST 1.1 or as long as in the Investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria.

    Also known as: Olaparib tablets

  • DrugPlacebo

    Placebo 300mg placebo tablets taken orally twice daily (except where this dose and formulation was previously not tolerated) until objective radiological disease progression as per RECIST 1.1 or as long as in the Investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria.

06

What researchers measure

Primary outcomes

  1. Efficacy: Progression-free Survival (PFS)

    PFS (per RECIST 1.1) was defined as the time from randomisation until the date of Investigator assessed objective radiological disease progression or death (by any cause in the absence of disease progression). Objective progression (per RECIST 1.1) is defined as at least a 20% increase in the sum of the diameters of the target lesions and an absolute increase of \>5 mm, or an overall non-target lesion assessment of progression or a new lesion. Patients who have not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST assessment.

    Time frame: At randomization visit and at every 12 weeks (+/- 7 days) until objective radiological disease progression as determined by the investigator or other discontinuation criteria are met (assessed upto 3.8 years)

Secondary outcomes

  1. Efficacy: Overall Survival (OS)

    OS was defined as the time from the date of randomisation until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive

    Time frame: From randomisation till Long-term follow-up (12-weekly beyond 30 days after last dose of study treatment) assessed upto 3.8 years

  2. Efficacy: Time to Progression by Gynecologic Cancer Intergroup (GCIG) Criteria

    Time to progression by RECIST or CA-125 or death is defined as the time from randomisation to the earlier date of RECIST progression or CA-125 progression or death by any cause. Patients without a CA-125 progression or a RECIST progression who are still alive at the time of analysis will be censored at the time of their last evaluable RECIST assessment and/or their last available CA-125 measurement, whichever is the earliest at the time of analysis. Patients that do not have any evaluable RECIST assessments or any CA-125 results post-randomisation will be censored at the date of randomisation

    Time frame: At screening (Visit 1) and at every 12 weeks (±7 days), until objective disease progression, based on progressive serial elevation of serum CA-125 according to the GCIG criteria, or until discontinuation for other reasons (assessed upto 3.8 years)

  3. Efficacy: Time to First Subsequent Treatment Commencement (TFST)

    TFST was assessed as time from randomisation to first subsequent treatment commencement or death if this occurs before commencement of first subsequent treatment. Any patient not known to have had a further subsequent therapy or death was censored at the last known time to have not received subsequent therapy

    Time frame: From follow-up i.e. 30 days after last dose of study medication till end of study (assessed every 12 weeks upto 3.8 years)

  4. Efficacy: Time to Second Subsequent Treatment Commencement (TSST)

    TSST was assessed as time from randomisation to second subsequent treatment commencement or death if this occurs before commencement of second subsequent treatment. Any patient not known to have had a further second subsequent therapy or death was censored at the last known time to have not received second subsequent therapy

    Time frame: From follow-up i.e. 30 days after last dose of study medication till end of study (assessed every 12 weeks upto 3.8 years)

  5. Efficacy: Time to Study Treatment Discontinuation (TDT)

    TDT was assessed as time from randomisation to study treatment discontinuation or death if this occurs before discontinuation of study treatment. Any patient not known to have died at the time of analysis and not known to have discontinued study treatment was censored based on the last recorded date on which the patient was known to be alive

    Time frame: From follow-up 30 days after last dose of study medication till long-term follow-up i.e. 12-weekly beyond 30 days after last dose of study treatment

  6. Efficacy: Change From Baseline in Health-related Quality of Life (HRQoL)

    Health related quality of life (HRQoL) of Olaparib maintenance retreatment compared to placebo as measured by the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) Trial Outcome Index (TOI) was determined. HRQoL was analysed using the FACT-O tool by mixed model for repeated measures (MMRM) analysis of the change from baseline in TOI score. FACT-O TOI is scored from O to 100 with higher scores denoting better quality of life. The higher the score, the better the HRQoL.

    Time frame: At Baseline, and from Day 1 until objective disease progression (assessed upto 2 years)

  7. Number of Patients With Adverse Events (AEs), and Serious Adverse Events (SAEs)

    All AEs/serious adverse events (SAEs) reported during the study were recorded.

    Time frame: At Baseline and from Day 1 till follow-up i.e. 30 days after last dose of study medication (assessed upto 3.8 years)

  8. Number of Patients With Adverse Event of Special Interest (AESI).

    All AESIs reported during the study were recorded.

    Time frame: At Baseline and from Day 1 till long-term follow-up i.e. 12-weekly beyond 30 days after last dose of study treatment (assessed upto 3.8 years)

07

Results

Posted Apr 19, 2022

Participant flow

This study was conducted at study centres in 11 countries (France, Italy, Spain, Germany, Poland, Belgium, Denmark, Israel, United Kingdom, Norway, and Canada) between 8-Jun-2017 and 15-Feb-2021.

Participant flow — Overall Study
MilestoneOlaparib (BRCA1/2 +ve)Placebo (BRCA1/2 +ve)Olaparib (BRCA1/2 -ve)Placebo (BRCA1/2 -ve)
Started74387236
Completed30155425
Not completed44231811
Withdrew: Death3722128
Withdrew: Lost to follow-up2022
Withdrew: Withdrawal by subject5141

Outcome measures

PrimaryEfficacy: Progression-free Survival (PFS)

PFS (per RECIST 1.1) was defined as the time from randomisation until the date of Investigator assessed objective radiological disease progression or death (by any cause in the absence of disease progression). Objective progression (per RECIST 1.1) is defined as at least a 20% increase in the sum of the diameters of the target lesions and an absolute increase of \>5 mm, or an overall non-target lesion assessment of progression or a new lesion. Patients who have not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST assessment.

Time frame:
At randomization visit and at every 12 weeks (+/- 7 days) until objective radiological disease progression as determined by the investigator or other discontinuation criteria are met (assessed upto 3.8 years)
Reported as:
Median · Months
Efficacy: Progression-free Survival (PFS)
MonthsOlaparib (BRCA1/2 +ve)Placebo (BRCA1/2 +ve)Olaparib (BRCA1/2 -ve)Placebo (BRCA1/2 -ve)
Efficacy: Progression-free Survival (PFS)4.3 (2.79 to 5.49)2.8 (2.73 to 4.96)5.3 (2.89 to 5.55)2.8 (2.79 to 2.89)
Statistical analysis
  • Olaparib (BRCA1/2 +ve) vs Placebo (BRCA1/2 +ve) · Stratified log-rank · p = 0.0220 · Hazard ratio (hr): 0.566 · 95% CI 0.372 to 0.868Hazard Ratio (Cox Proportional Hazards model)
  • Olaparib (BRCA1/2 -ve) vs Placebo (BRCA1/2 -ve) · Stratified log-rank · p = 0.0023 · Hazard ratio (hr): 0.430 · 95% CI 0.264 to 0.708Hazard Ratio (Cox Proportional Hazards model)
SecondaryEfficacy: Overall Survival (OS)

OS was defined as the time from the date of randomisation until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive

Time frame:
From randomisation till Long-term follow-up (12-weekly beyond 30 days after last dose of study treatment) assessed upto 3.8 years
Reported as:
Median · Months
Efficacy: Overall Survival (OS)
MonthsOlaparib (BRCA1/2 +ve)Placebo (BRCA1/2 +ve)Olaparib (BRCA1/2 -ve)Placebo (BRCA1/2 -ve)
Efficacy: Overall Survival (OS)20.1 (16.39 to 25.43)20.9 (15.21 to 23.92)23.2 (15.15 to NA)30.2 (17.84 to NA)
SecondaryEfficacy: Time to Progression by Gynecologic Cancer Intergroup (GCIG) Criteria

Time to progression by RECIST or CA-125 or death is defined as the time from randomisation to the earlier date of RECIST progression or CA-125 progression or death by any cause. Patients without a CA-125 progression or a RECIST progression who are still alive at the time of analysis will be censored at the time of their last evaluable RECIST assessment and/or their last available CA-125 measurement, whichever is the earliest at the time of analysis. Patients that do not have any evaluable RECIST assessments or any CA-125 results post-randomisation will be censored at the date of randomisation

Time frame:
At screening (Visit 1) and at every 12 weeks (±7 days), until objective disease progression, based on progressive serial elevation of serum CA-125 according to the GCIG criteria, or until discontinuation for other reasons (assessed upto 3.8 years)
Reported as:
Median · Months
Efficacy: Time to Progression by Gynecologic Cancer Intergroup (GCIG) Criteria
MonthsOlaparib (BRCA1/2 +ve)Placebo (BRCA1/2 +ve)Olaparib (BRCA1/2 -ve)Placebo (BRCA1/2 -ve)
Efficacy: Time to Progression by Gynecologic Cancer Intergroup (GCIG) Criteria2.8 (2.76 to 5.36)2.8 (2.73 to 3.98)2.9 (2.79 to 5.32)2.79 (2.63 to 2.79)
SecondaryEfficacy: Time to First Subsequent Treatment Commencement (TFST)

TFST was assessed as time from randomisation to first subsequent treatment commencement or death if this occurs before commencement of first subsequent treatment. Any patient not known to have had a further subsequent therapy or death was censored at the last known time to have not received subsequent therapy

Time frame:
From follow-up i.e. 30 days after last dose of study medication till end of study (assessed every 12 weeks upto 3.8 years)
Reported as:
Median · Months
Efficacy: Time to First Subsequent Treatment Commencement (TFST)
MonthsOlaparib (BRCA1/2 +ve)Placebo (BRCA1/2 +ve)Olaparib (BRCA1/2 -ve)Placebo (BRCA1/2 -ve)
Efficacy: Time to First Subsequent Treatment Commencement (TFST)5.8 (4.67 to 9.17)5.1 (3.58 to 6.11)7.9 (5.88 to 11.07)4.3 (3.68 to 6.41)
SecondaryEfficacy: Time to Second Subsequent Treatment Commencement (TSST)

TSST was assessed as time from randomisation to second subsequent treatment commencement or death if this occurs before commencement of second subsequent treatment. Any patient not known to have had a further second subsequent therapy or death was censored at the last known time to have not received second subsequent therapy

Time frame:
From follow-up i.e. 30 days after last dose of study medication till end of study (assessed every 12 weeks upto 3.8 years)
Reported as:
Median · Months
Efficacy: Time to Second Subsequent Treatment Commencement (TSST)
MonthsOlaparib (BRCA1/2 +ve)Placebo (BRCA1/2 +ve)Olaparib (BRCA1/2 -ve)Placebo (BRCA1/2 -ve)
Efficacy: Time to Second Subsequent Treatment Commencement (TSST)13.1 (11.10 to 15.64)11.7 (8.61 to 13.60)15.4 (11.60 to 23.62)12.7 (10.35 to 16.62)
SecondaryEfficacy: Time to Study Treatment Discontinuation (TDT)

TDT was assessed as time from randomisation to study treatment discontinuation or death if this occurs before discontinuation of study treatment. Any patient not known to have died at the time of analysis and not known to have discontinued study treatment was censored based on the last recorded date on which the patient was known to be alive

Time frame:
From follow-up 30 days after last dose of study medication till long-term follow-up i.e. 12-weekly beyond 30 days after last dose of study treatment
Reported as:
Median · Months
Efficacy: Time to Study Treatment Discontinuation (TDT)
MonthsOlaparib (BRCA1/2 +ve)Placebo (BRCA1/2 +ve)Olaparib (BRCA1/2 -ve)Placebo (BRCA1/2 -ve)
Efficacy: Time to Study Treatment Discontinuation (TDT)4.5 (3.35 to 5.59)3.4 (2.86 to 5.49)5.6 (3.42 to 5.78)3.1 (2.79 to 3.91)
SecondaryEfficacy: Change From Baseline in Health-related Quality of Life (HRQoL)

Health related quality of life (HRQoL) of Olaparib maintenance retreatment compared to placebo as measured by the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) Trial Outcome Index (TOI) was determined. HRQoL was analysed using the FACT-O tool by mixed model for repeated measures (MMRM) analysis of the change from baseline in TOI score. FACT-O TOI is scored from O to 100 with higher scores denoting better quality of life. The higher the score, the better the HRQoL.

Time frame:
At Baseline, and from Day 1 until objective disease progression (assessed upto 2 years)
Reported as:
Mean · Change in scores
Efficacy: Change From Baseline in Health-related Quality of Life (HRQoL)
Change in scoresOlaparib (BRCA1/2 +ve)Placebo (BRCA1/2 +ve)Olaparib (BRCA1/2 -ve)Placebo (BRCA1/2 -ve)
Efficacy: Change From Baseline in Health-related Quality of Life (HRQoL)-1.27 ± 0.551.67 ± 0.89-2.08 ± 0.600.58 ± 0.90
SecondaryNumber of Patients With Adverse Events (AEs), and Serious Adverse Events (SAEs)

All AEs/serious adverse events (SAEs) reported during the study were recorded.

Time frame:
At Baseline and from Day 1 till follow-up i.e. 30 days after last dose of study medication (assessed upto 3.8 years)
Reported as:
Count of participants · Participants
Number of Patients With Adverse Events (AEs), and Serious Adverse Events (SAEs)
ParticipantsOlaparib (BRCA1/2 +ve)Placebo (BRCA1/2 +ve)Olaparib (BRCA1/2 -ve)Placebo (BRCA1/2 -ve)
Any Treatment emergent adverse event (TEAE)64336631
Any TEAE causally related to treatment50235314
Any TEAE of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher112153
Any TEAE of CTCAE grade 3 or higher, causally related to treatment5151
Any TEAE with outcome = death0000
Any TEAE with outcome = death, causally related to treatment0000
Any treatment-emergent SAE (including events with outcome = death)50112
Any treatment-emergent SAE (including events with outcome = death), causally related to treatment1030
Any TEAE leading to discontinuation of study medication2010
Any TEAE leading to discontinuation of study medication, causally related to treatment1000
Any TEAE leading to dose modification186282
Any TEAE leading to dose modification, causally related to treatment145211
SecondaryNumber of Patients With Adverse Event of Special Interest (AESI).

All AESIs reported during the study were recorded.

Time frame:
At Baseline and from Day 1 till long-term follow-up i.e. 12-weekly beyond 30 days after last dose of study treatment (assessed upto 3.8 years)
Reported as:
Count of participants · Participants
Number of Patients With Adverse Event of Special Interest (AESI).
ParticipantsOlaparib (BRCA1/2 +ve)Placebo (BRCA1/2 +ve)Olaparib (BRCA1/2 -ve)Placebo (BRCA1/2 -ve)
Number of Patients With Adverse Event of Special Interest (AESI).1110

Adverse events

Collected over From Screening (Day -27 to Day 0) up to 12-weekly beyond 30 days after the last dose of study treatment (assessed up to 3.8 years). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Olaparib (BRCA1/2 +ve)39/74 (52.7%)5/74 (6.8%)64/74 (86.5%)
Placebo (BRCA1/2 +ve)22/38 (57.9%)0/38 (0%)33/38 (86.8%)
Olaparib (BRCA1/2 -ve)15/72 (20.8%)11/72 (15.3%)65/72 (90.3%)
Placebo (BRCA1/2 -ve)8/36 (22.2%)2/36 (5.6%)30/36 (83.3%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventOlaparib (BRCA1/2 +ve)Placebo (BRCA1/2 +ve)Olaparib (BRCA1/2 -ve)Placebo (BRCA1/2 -ve)
Incarcerated herniaGeneral disorders0/740/380/721/36
Hepatic haematomaHepatobiliary disorders0/740/380/721/36
COVID-19 pneumoniaInfections and infestations2/740/380/720/36
AnaemiaBlood and lymphatic system disorders1/740/381/720/36
NeutropeniaBlood and lymphatic system disorders1/740/381/720/36
Febrile neutropeniaBlood and lymphatic system disorders0/740/381/720/36
Supraventricular tachycardiaCardiac disorders0/740/381/720/36
DiverticulumGastrointestinal disorders0/740/381/720/36
Ileal perforationGastrointestinal disorders0/740/381/720/36
IleusGastrointestinal disorders0/740/381/720/36
Most frequent other events
Showing 10 of 189
Most frequent other events
EventOlaparib (BRCA1/2 +ve)Placebo (BRCA1/2 +ve)Olaparib (BRCA1/2 -ve)Placebo (BRCA1/2 -ve)
NauseaGastrointestinal disorders29/744/3830/723/36
Abdominal painGastrointestinal disorders8/7411/386/726/36
AstheniaGeneral disorders18/743/3815/722/36
AnaemiaBlood and lymphatic system disorders13/742/3815/721/36
FatigueGeneral disorders13/745/3813/722/36
DiarrhoeaGastrointestinal disorders10/745/3812/722/36
ConstipationGastrointestinal disorders9/746/389/722/36
NeutropeniaBlood and lymphatic system disorders4/744/388/723/36
ArthralgiaMusculoskeletal and connective tissue disorders0/743/382/724/36
VomitingGastrointestinal disorders8/744/386/721/36

Baseline characteristics

Full analysis set (FAS) consisted of all randomised patients analysed on an intent-to-treat (ITT) basis.

Age, Continuous
Age, Continuous(Years)Olaparib (BRCA1/2 +ve)Placebo (BRCA +ve)Olaparib (BRCA1/2 -ve)Placebo (BRCA 1/2 -ve)Total
Mean59.2 ± 9.3161.5 ± 9.2264.2 ± 9.6463.3 ± 9.0561.9 ± 9.54
Age, Customized
Age, Customized(Participants)Olaparib (BRCA1/2 +ve)Placebo (BRCA +ve)Olaparib (BRCA1/2 -ve)Placebo (BRCA 1/2 -ve)Total
< 501134119
≥ 50 to < 6540202919108
≥ 65 to < 752012301173
≥ 75339520
Sex: Female, Male
Sex: Female, Male(Participants)Olaparib (BRCA1/2 +ve)Placebo (BRCA +ve)Olaparib (BRCA1/2 -ve)Placebo (BRCA 1/2 -ve)Total
Female74387236220
Male00000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Olaparib (BRCA1/2 +ve)Placebo (BRCA +ve)Olaparib (BRCA1/2 -ve)Placebo (BRCA 1/2 -ve)Total
White71356633205
American Indian or Alaska Native00000
Asian00000
Black or African American00101
Hawaiian Native or Other Pacific Islander00000
Other335213
Missing Data00011
08

Study locations

82 sites
  • Research Site
    Leuven, 3000, Belgium
  • Research Site
    Namur, 5000, Belgium
  • Research Site
    London, Ontario N6A 4L6, Canada
  • Research Site
    Toronto, M5G 2M9, Canada
  • Research Site
    Aalborg, 9000, Denmark
  • Research Site
    København Ø, 2100, Denmark
  • Research Site
    Odense C, 5000, Denmark
  • Research Site
    Besançon, 25000, France
  • Research Site
    Bordeaux, 33076, France
  • Research Site
    Caen Cedex 05, 14076, France
  • Research Site
    Clermont Ferrand cedex 01, 63011, France
  • Research Site
    Lille, 59000, France
  • Research Site
    Lyon, 69008, France
  • Research Site
    Montpellier, 34298, France
  • Research Site
    Nantes, 44202, France
  • Research Site
    Nice, 6189, France
  • Research Site
    Paris Cedex 20, 75020, France
  • Research Site
    Paris Cedex 5, 75248, France
  • Research Site
    Paris, 75012, France
  • Research Site
    Paris, 75015, France
  • Research Site
    Pierre Benite, 69495, France
  • Research Site
    Plerin SUR MER, 22190, France
  • Research Site
    Saint Herblain, 44805, France
  • Research Site
    Saint-cloud, 92210, France
  • Research Site
    Toulouse Cedex 09, 31059, France
  • Research Site
    Vandoeuvre-Les-Nancy, 54511, France
  • Research Site
    Dresden, 01307, Germany
  • Research Site
    Essen, 45136, Germany
  • Research Site
    Frankfurt, 60596, Germany
  • Research Site
    Hamburg, 20246, Germany
  • Research Site
    Heidelberg, 69120, Germany
  • Research Site
    Jena, 07747, Germany
  • Research Site
    Lübeck, 23538, Germany
  • Research Site
    Mannheim, 68167, Germany
  • Research Site
    München, D-80336, Germany
  • Research Site
    Rostock, 18057, Germany
  • Research Site
    Stuttgart, 70376, Germany
  • Research Site
    Ulm, 89075, Germany
  • Research Site
    Wiesbaden, 65199, Germany
  • Research Site
    Jerusalem, Israel
  • Research Site
    Kfar Saba, 49281, Israel
  • Research Site
    petach Tikva, 49100, Israel
  • Research Site
    Ramat Gan, 5265601, Israel
  • Research Site
    Tel-Aviv, 6423906, Israel
  • Research Site
    Bologna, 40138, Italy
  • Research Site
    Brescia, 25123, Italy
  • Research Site
    Candiolo, 10060, Italy
  • Research Site
    Catania, 95100, Italy
  • Research Site
    Lecce, 73100, Italy
  • Research Site
    Milano, 20132, Italy
  • Research Site
    Milano, 20133, Italy
  • Research Site
    Milano, 20141, Italy
  • Research Site
    Napoli, 80131, Italy
  • Research Site
    Reggio Emilia, 42100, Italy
  • Research Site
    Roma, 00168, Italy
  • Research Site
    Torino, 10126, Italy
  • Research Site
    Oslo, N-0379, Norway
  • Research Site
    Grzepnica, 72-003, Poland
  • Research Site
    Lublin, 20-090, Poland
  • Research Site
    Olsztyn, 10-513, Poland
  • Research Site
    Poznań, 60-569, Poland
  • Research Site
    Warszawa, 02-781, Poland
  • Research Site
    A Coruña, 15006, Spain
  • Research Site
    Barcelona, 08036, Spain
  • Research Site
    Córdoba, 14004, Spain
  • Research Site
    L'Hospitalet de Llobregat, 08907, Spain
  • Research Site
    Madrid, 08035, Spain
  • Research Site
    Madrid, 28033, Spain
  • Research Site
    Madrid, 28041, Spain
  • Research Site
    Madrid, 28046, Spain
  • Research Site
    Malaga, 29010, Spain
  • Research Site
    Sevilla, 41013, Spain
  • Research Site
    Valencia, 46009, Spain
  • Research Site
    Valencia, 46010, Spain
  • Research Site
    Valencia, 46026, Spain
  • Research Site
    Glasgow, G12 OYN, United Kingdom
  • Research Site
    Leeds, LS9 7TF, United Kingdom
  • Research Site
    London, SW36JJ, United Kingdom
  • Research Site
    London, W12 0HS, United Kingdom
  • Research Site
    Sutton, SM25PT, United Kingdom
  • Research Site
    Taunton, TA1 5DA, United Kingdom
  • Research Site
    Wirral, CH63 4JY, United Kingdom
09

References and documents

Study documents

  • Study protocol · Oct 15, 2020
  • Statistical analysis plan · Apr 16, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03106987
Lead sponsor
AstraZeneca
Collaborators
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Responsible party
Sponsor
First posted
Apr 11, 2017
Start date
Jun 8, 2017
Primary completion
Feb 15, 2021
Completion
Feb 17, 2022
Results posted
Apr 19, 2022
Last update
Oct 7, 2022

Study contacts

Eric Pujade-Lauraine, MD, PhD
principal investigator · Hôpital Hôtel-Dieu

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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