A Study to Examine Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer.
OReO
A Phase IIIb, Randomised, Double-blind, Placebo-controlled, Multicentre Study of Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer Previously Treated With a PARPi and Responding to Repeat Platinum Chemotherapy
1 other identifier
interventional
220
11 countries
82
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2017
Longer than P75 for phase_3
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2017
CompletedFirst Posted
Study publicly available on registry
April 11, 2017
CompletedStudy Start
First participant enrolled
June 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 17, 2022
CompletedResults Posted
Study results publicly available
April 19, 2022
CompletedOctober 7, 2022
June 1, 2022
3.7 years
March 24, 2017
February 15, 2022
September 13, 2022
Conditions
Keywords
Outcome Measures
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.
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 (8)
Efficacy: Overall Survival (OS)
From randomisation till Long-term follow-up (12-weekly beyond 30 days after last dose of study treatment) assessed upto 3.8 years
Efficacy: Time to Progression by Gynecologic Cancer Intergroup (GCIG) Criteria
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)
Efficacy: Time to First Subsequent Treatment Commencement (TFST)
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)
Efficacy: Time to Second Subsequent Treatment Commencement (TSST)
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)
Efficacy: Time to Study Treatment Discontinuation (TDT)
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
- +3 more secondary outcomes
Study Arms (2)
Active Comparator: Olaparib
EXPERIMENTALOlaparib 300mg tablets administered orally twice daily continuously.
Placebo Comparator: Placebo
PLACEBO COMPARATORMatching placebo 300mg tablets administered orally twice daily continuously.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Provision of informed consent prior to any study specific procedures
- 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.
You may not qualify if:
- 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.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (82)
Research Site
Leuven, 3000, Belgium
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Namur, 5000, Belgium
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London, Ontario, N6A 4L6, Canada
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Toronto, M5G 2M9, Canada
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Aalborg, 9000, Denmark
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København Ø, 2100, Denmark
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Odense C, 5000, Denmark
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Besançon, 25000, France
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Bordeaux, 33076, France
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Caen, 14076, France
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Clermont-Ferrand, 63011, France
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Lille, 59000, France
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Lyon, 69008, France
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Montpellier, 34298, France
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Nantes, 44202, France
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Nice, 6189, France
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Paris, 75012, France
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Paris, 75015, France
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Paris, 75020, France
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Paris, 75248, France
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Pierre-Bénite, 69495, France
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Plerin SUR MER, 22190, France
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Saint-Cloud, 92210, France
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Saint-Herblain, 44805, France
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Toulouse, 31059, France
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Vandœuvre-lès-Nancy, 54511, France
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Dresden, 01307, Germany
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Essen, 45136, Germany
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Frankfurt, 60596, Germany
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Hamburg, 20246, Germany
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Heidelberg, 69120, Germany
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Jena, 07747, Germany
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Lübeck, 23538, Germany
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Mannheim, 68167, Germany
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München, D-80336, Germany
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Rostock, 18057, Germany
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Stuttgart, 70376, Germany
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Ulm, 89075, Germany
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Wiesbaden, 65199, Germany
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Jerusalem, Israel
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Kfar Saba, 49281, Israel
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Petah Tikva, 49100, Israel
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Ramat Gan, 5265601, Israel
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Tel Aviv, 6423906, Israel
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Bologna, 40138, Italy
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Brescia, 25123, Italy
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Candiolo, 10060, Italy
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Catania, 95100, Italy
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Lecce, 73100, Italy
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Milan, 20132, Italy
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Milan, 20133, Italy
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Milan, 20141, Italy
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Napoli, 80131, Italy
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Reggio Emilia, 42100, Italy
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Roma, 00168, Italy
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Torino, 10126, Italy
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Oslo, N-0379, Norway
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Grzepnica, 72-003, Poland
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Lublin, 20-090, Poland
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Olsztyn, 10-513, Poland
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Poznan, 60-569, Poland
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Warsaw, 02-781, Poland
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A Coruña, 15006, Spain
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Barcelona, 08036, Spain
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Córdoba, 14004, Spain
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L'Hospitalet de Llobregat, 08907, Spain
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Madrid, 08035, Spain
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Madrid, 28033, Spain
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Madrid, 28041, Spain
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Madrid, 28046, Spain
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Málaga, 29010, Spain
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Seville, 41013, Spain
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Valencia, 46009, Spain
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Valencia, 46010, Spain
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Valencia, 46026, Spain
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Glasgow, G12 OYN, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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London, SW36JJ, United Kingdom
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London, W12 0HS, United Kingdom
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Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
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Sutton, SM25PT, United Kingdom
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Taunton, TA1 5DA, United Kingdom
Related Publications (1)
Pujade-Lauraine E, Selle F, Scambia G, Asselain B, Marme F, Lindemann K, Colombo N, Madry R, Glasspool R, Vergote I, Korach J, Lheureux S, Dubot C, Oaknin A, Zamagni C, Heitz F, Gladieff L, Rubio-Perez MJ, Scollo P, Blakeley C, Shaw B, Ray-Coquard I, Redondo A; OReO/ENGOT-ov38 investigators. Maintenance olaparib rechallenge in patients with platinum-sensitive relapsed ovarian cancer previously treated with a PARP inhibitor (OReO/ENGOT-ov38): a phase IIIb trial. Ann Oncol. 2023 Dec;34(12):1152-1164. doi: 10.1016/j.annonc.2023.09.3110. Epub 2023 Oct 4.
PMID: 37797734DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Head
- Organization
- AstraZeneca Clinical Study Information Center
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Pujade-Lauraine, MD, PhD
Hôpital Hôtel-Dieu
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2017
First Posted
April 11, 2017
Study Start
June 8, 2017
Primary Completion
February 15, 2021
Study Completion
February 17, 2022
Last Updated
October 7, 2022
Results First Posted
April 19, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 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 rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified 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.
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.