Study Evaluating the Efficacy of Maintenance Olaparib and Cediranib or Olaparib Alone in Ovarian Cancer Patients
ICON9
International Phase III Randomised Study to Evaluate the Efficacy of Maintenance Therapy With Olaparib and Cediranib or Olaparib Alone in Patients With Relapsed Ovarian Cancer Following a Response to Platinum-based Chemotherapy
1 other identifier
interventional
330
4 countries
54
Brief Summary
ICON 9 will assess the efficacy, safety and tolerability of maintenance olaparib in combination with cediranib compared to maintenance olaparib alone following a response to platinum-based chemotherapy in women with relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer. Prognostic and predictive factors will be studied from tumour and blood samples.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 ovarian-cancer
Started Jun 2018
Typical duration for phase_3 ovarian-cancer
54 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
July 31, 2017
CompletedFirst Posted
Study publicly available on registry
September 12, 2017
CompletedStudy Start
First participant enrolled
June 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedSeptember 27, 2022
June 1, 2022
5.5 years
July 31, 2017
September 26, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival (PFS) measured from the date of randomisation to the date of objective progression (investigator assessed using RECIST v1.1) or date of death from any cause (in the absence of progression)
Progression free survival (PFS) measured from the time of randomisation.
3 years
Secondary Outcomes (9)
Toxicity
3 years
PFS and OS measured from the time of starting chemotherapy
3 years
Adherence to maintenance therapy- compliance and dose reductions and interruptions
3 years
TSST (the time from randomisation to start of second subsequent therapy or death)
3 years
Quality of life using EORTC QLQ C30
3 years
- +4 more secondary outcomes
Study Arms (2)
Olaparib and Cediranib
EXPERIMENTALPatients will receive oral olaparib 300mg BD and oral cediranib 20mg OD. Patients will attend hospital for a 2 weekly review for the first 8 weeks, then 4 weekly for year 1 and 8 weekly for year 2 onwards until discontinuation of all trial drugs. Treatment may continue beyond progression until the next line of treatment if the patient is deemed to still be deriving clinical benefit. QOL instruments will be collected at baseline, every clinic visit and continue to be completed after relapse.
Olaparib
ACTIVE COMPARATORPatients will receive oral olaparib 300mg BD. Patients will attend hospital for a 2 weekly review for the first 8 weeks, then 4 weekly for year 1 and 8 weekly for year 2 onwards until discontinuation of all trial drugs. Treatment may continue beyond progression until the next line of treatment if the patient is deemed to still be deriving clinical benefit. QOL instruments will be collected at baseline, every clinic visit and continue to be completed after relapse.
Interventions
Eligibility Criteria
You may qualify if:
- Provision of informed consent prior to any study specific procedures and the ability to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations.
- Females aged ≥ 18 years with previous histologically proven diagnosis of high grade serous or endometrioid carcinoma of the
- Ovary
- Fallopian tube
- or peritoneum, progressing \>6 months after day 1 of the last cycle of first-line platinum-based chemotherapy and requiring treatment with platinum-based chemotherapy on the basis of radiological evidence of disease or following surgical resection of recurrent disease.
- Patients must have had CT or MRI proven relapsed disease (measureable or non-measureable abnormalities supported by GCIG CA125 criteria of progression), or have had debulking surgery for first relapse.
- Patients showing evidence of response to chemotherapy mid-treatment (post 3 or 4 cycles), either by CA125 or CT/MRI scan, should be approached for ICON9 trial registration to allow for BRCA mutation status to be assessed (germline and/ or somatic). Patients who underwent surgical debulking must show no evidence of disease progression by the assessments above (CA125 and CT/MRI scan) in order to be approached for registration.
- Prior front-line maintenance therapy with bevacizumab is permitted.
- ECOG performance status 0-1.
- Patients should 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 prior to study treatment and confirmed prior to treatment on day 1.
- Postmenopausal is defined as age ≥60 years, or:
- Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments
- Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post-menopausal range for women under 50
- Radiation-induced oophorectomy with last menses \>1 year ago
- +28 more criteria
You may not qualify if:
- Non-epithelial ovarian cancer, carcinosarcoma, clear cell carcinoma and mucinous carcinomas.
- Arterial thrombotic event (including transient ischemic attack, cerebrovascular accident, and peripheral arterial embolus) within the last 12 months.
- Patients unable to swallow orally administered medication and patients with gastrointestinal impairment that could affect ability to take, or absorption of oral medicines including sub-acute or complete bowel obstruction.
- Clinically significant signs and/or symptoms of bowel obstruction within 3 months prior to starting treatment.
- History of intra-abdominal abscess within 3 months prior to starting treatment (randomisation).
- History of GI perforation. Patients with a history of abdominal fistula will be considered eligible if the fistula was surgically repaired, there has been no evidence of fistula for at least 6 months prior to starting treatment, and patient is deemed to be at low risk of recurrent fistula.
- Symptomatic or clinically significant inflammatory bowel disease (Crohn's disease or ulcerative colitis).
- Patients with an ileostomy will be excluded.
- Evidence of severe or uncontrolled cardiac disease.
- Myocardial infarct or unstable angina within the last 6 months
- New York Health Association (NHYA) ≥ grade 2 congestive heart failure
- Cardiac ventricular arrhythmias requiring medication
- History of 2nd or 3rd degree atrioventricular conduction defects
- Resting ECG with QTcF \> 470msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.
- Evidence of active bleeding or bleeding diathesis.
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
Calvary Mater Hospital
Sydney, New South Wales, Australia
Campbelltown Hospital
Sydney, New South Wales, Australia
Prince of Wales Hospital
Sydney, New South Wales, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Border Medical Oncology
Albury, Australia
Flinders Medical Centre
Bedford Park, Australia
Pindara Private Hospital
Benowa, Australia
Chris O'Brien Lifehouse
Camperdown, Australia
Canberra Hospital
Canberra, Australia
Monash Health
Clayton, Australia
Gosford Hospital
Gosford, Australia
Peter MacCallum Cancer Centre
Melbourne, Australia
ICON Cancer Centre
South Brisbane, Australia
Mater Cancer Centre
South Brisbane, Australia
Townsville Hospital
Townsville, Australia
Westmead Hospital
Westmead, Australia
Cross Cancer Institute
Edmonton, Canada
Centre Hospitalier de L'Universite de Montreal
Montreal, Canada
CHU de Quebec
Québec, Canada
Princess Margaret Cancer Centre
Toronto, Canada
Sunnybrook Hospital
Toronto, Canada
BC Cancer Vancouver
Vancouver, Canada
BC Cancer Victoria
Victoria, Canada
Auckland City Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Furness General Hospital
Barrow in Furness, United Kingdom
Belfast City Hospital
Belfast, United Kingdom
Royal Sussex County Hospital
Brighton, United Kingdom
Addenbrookes Hospital
Cambridge, United Kingdom
Kent & Canterbury Hospital
Canterbury, United Kingdom
Velindre Cancer Centre
Cardiff, United Kingdom
Cheltenham General Hospital
Cheltenham, United Kingdom
University Hospital Coventry
Coventry, United Kingdom
Ninewells Hospital
Dundee, United Kingdom
Western General Hospital
Edinburgh, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Royal Surrey County Hospital
Guildford, United Kingdom
Royal Lancaster Infirmary
Lancaster, United Kingdom
Guy's Hospital
London, United Kingdom
Hammersmith Hospital
London, United Kingdom
Mount Vernon Cancer Centre
London, United Kingdom
Royal Marsden NHS Foundation Trust
London, United Kingdom
University College London Hospital
London, United Kingdom
The Christie Hospital
Manchester, United Kingdom
Queen Elizabeth the Queen Mother Hospital
Margate, United Kingdom
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Queen Alexandra Hospital
Portsmouth, United Kingdom
Royal Berkshire Hospital
Reading, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
Lister Hospital
Stevenage, United Kingdom
Singleton Hospital
Swansea, United Kingdom
Musgrove Park Hospital
Taunton, United Kingdom
Royal Cornwall
Truro, United Kingdom
Related Publications (2)
Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
PMID: 37185961DERIVEDElyashiv O, Ledermann J, Parmar G, Farrelly L, Counsell N, Feeney A, El-Khouly F, Macdonald I, Neto A, Arthur-Darkwa E, Burnett E, Jayson GC, Mileshkin L, Gourley C, Nicum S. ICON 9-an international phase III randomized study to evaluate the efficacy of maintenance therapy with olaparib and cediranib or olaparib alone in patients with relapsed platinum-sensitive ovarian cancer following a response to platinum-based chemotherapy. Int J Gynecol Cancer. 2021 Jan;31(1):134-138. doi: 10.1136/ijgc-2020-002073. Epub 2020 Oct 23.
PMID: 33097567DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2017
First Posted
September 12, 2017
Study Start
June 15, 2018
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
September 27, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share