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Ovarian CancerPhase 3ICON9NCT03278717

Study Evaluating the Efficacy of Maintenance Olaparib and Cediranib or Olaparib Alone in Ovarian Cancer Patients

A Phase 3 study testing Olaparib and Cediranib in people with Ovarian Cancer, run by University College, London at 54 sites in 4 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Olaparib and Cediranib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
54 sitesin 4 countries
Study dates
15 Jun 2018to Dec 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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.
Show all 34Show fewer
  • 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.
  • Significant haemorrhage of >30ml in a single episode within the last 3 months or any haemoptysis (>5ml fresh blood in last 4 weeks).
  • Malignancy treated within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS) of the breast, Stage 1, grade 1 endometrial carcinoma.
  • Previous treatment with VEGFR tyrosine kinase inhibitors or PARP inhibitors are not permitted.
  • Patients with a known hypersensitivity to excipients of cediranib or olaparib.
  • Persisting ≥ grade 2 CTCAE toxicity (except alopecia and neuropathy) from previous anti-cancer treatment.
  • Major surgery within 14 days before anticipated start of treatment and patients must have recovered from any effects of major surgery.
  • Inability to attend or comply with treatment or follow-up scheduling.
  • Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicated the use of an investigation drug or puts the patients at high risk for treatment-related complications.
  • Pregnant or breast-feeding women are excluded. Women of childbearing potential will be excluded unless effective methods of contraception are used from signing of the informed consent, throughout the period of taking study treatment and for at least 6 weeks after last dose of trial drug(s).
  • Treatment with any other investigational agent, or participation in another interventional clinical trial within 28 days prior to enrolment (randomisation).
  • Concomitant use of known strong CYP3A4 inhibitors (such as systemic ketoconazole, itraconazole, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir, telithromycin and clarithromycin or moderate CYP3A inhibitors (e.g. systemic Ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.
  • Concomitant use of known strong (e.g. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
  • Patients with myelodysplastic syndrome/acute myeloid leukaemia.
  • Other psychological, psychiatric, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results.
  • Patients with known active hepatitis (i.e. Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids.
  • Immunocompromised patients e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV) and are receiving antiviral therapy.
  • Patients with symptomatic uncontrolled brain or meningeal metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment.
  • Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
  • Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).

Trial locations and contacts

54 sites in 4 countries.

Ian Macdonald contact

+44 (0)20 7679 9808

ctc.ICON9@ucl.ac.uk

Mandy Feeney contact

+44 (0)20 7679 9890

ctc.ICON9@ucl.ac.uk

54 sites in 4 countries

United Kingdom29 sites, 27 recruiting

  • Furness General Hospital

    Barrow in Furness

    Sarah Moon

    Recruiting

  • Belfast City Hospital

    Belfast

    Terminated

  • Royal Sussex County Hospital

    Brighton

    Rebecca Herbertson

    Recruiting

  • Addenbrookes Hospital

    Cambridge

    Joo Ern Ang

    Recruiting

  • Kent & Canterbury Hospital

    Canterbury

    Justin Waters

    Recruiting

  • Velindre Cancer Centre

    Cardiff

    Louise Hanna

    Recruiting

  • Cheltenham General Hospital

    Cheltenham

    Audrey Cook

    Recruiting

  • University Hospital Coventry

    Coventry

    Lucy McAven

    Recruiting

  • Ninewells Hospital

    Dundee

    Michelle Ferguson

    Recruiting

  • Western General Hospital

    Edinburgh

    Charlie Gourley

    Recruiting

  • Beatson West of Scotland Cancer Centre

    Glasgow

    Ros Glasspool

    Recruiting

  • Royal Surrey County Hospital

    Guildford

    Agnieszka Michael

    Recruiting

  • Royal Lancaster Infirmary

    Lancaster

    Sarah Moon

    Recruiting

  • Guy's Hospital

    London

    Ana Montes

    Recruiting

  • Hammersmith Hospital

    London

    Laura Tookman

    Recruiting

  • Mount Vernon Cancer Centre

    London

    Ignacio Vazquez

    Recruiting

  • Royal Marsden NHS Foundation Trust

    London

    Susanna Banerjee

    Recruiting

  • University College London Hospital

    London

    Jonathan Ledermann

    Recruiting

  • The Christie Hospital

    Manchester

    Gordon Jayson

    Recruiting

  • Queen Elizabeth the Queen Mother Hospital

    Margate

    Justin Waters

    Recruiting

  • Clatterbridge Cancer Centre

    Metropolitan Borough of Wirral

    Danielle Shaw

    Recruiting

  • Churchill Hospital

    Oxford

    Shibani Nicum

    Recruiting

  • Queen Alexandra Hospital

    Portsmouth

    Active, not recruiting

  • Royal Berkshire Hospital

    Reading

    Madhumita Battacharyya

    Recruiting

  • Southampton General Hospital

    Southampton

    Clare Green

    Recruiting

  • Lister Hospital

    Stevenage

    Ignacio Vazquez

    Recruiting

  • Singleton Hospital

    Swansea

    Rachel Jones

    Recruiting

  • Musgrove Park Hospital

    Taunton

    Emma Cattell

    Recruiting

  • Royal Cornwall

    Truro

    John McGrane

    Recruiting

Other trials in United Kingdom

Australia16 sites, 16 recruiting

  • Border Medical Oncology

    Albury

    Christopher Steer

    Recruiting

  • Flinders Medical Centre

    Bedford Park

    Ganessan Kichenadasse

    Recruiting

  • Pindara Private Hospital

    Benowa

    Marco Matos

    Recruiting

  • Chris O'Brien Lifehouse

    Camperdown

    Michelle Harrison

    Recruiting

  • Canberra Hospital

    Canberra

    Alison Davies

    Recruiting

  • Monash Health

    Clayton

    Kate Webber

    Recruiting

  • Gosford Hospital

    Gosford

    Craig Kukard

    Recruiting

  • Royal Hobart Hospital

    Hobart, Tasmania

    Allison Black

    Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne

    Linda Mileshkin

    Recruiting

  • ICON Cancer Centre

    South Brisbane

    Jim Coward

    Recruiting

  • Mater Cancer Centre

    South Brisbane

    Catherine Shannon

    Recruiting

  • Calvary Mater Hospital

    Sydney, New South Wales

    Janine Lombard

    Recruiting

  • Campbelltown Hospital

    Sydney, New South Wales

    Felicia Roncolato

    Recruiting

  • Prince of Wales Hospital

    Sydney, New South Wales

    Michael Friedlander

    Recruiting

  • Townsville Hospital

    Townsville

    Abhishek Joshi

    Recruiting

  • Westmead Hospital

    Westmead

    Paul Harnett

    Recruiting

Other trials in Australia

Canada7 sites, 7 recruiting

  • Cross Cancer Institute

    Edmonton

    Michael Kolinsky

    Recruiting

  • Centre Hospitalier de L'Universite de Montreal

    Montreal

    Diane Provencher

    Recruiting

  • CHU de Quebec

    Québec

    Vincent Castonguay

    Recruiting

  • Princess Margaret Cancer Centre

    Toronto

    Stephanie Lheureux

    Recruiting

  • Sunnybrook Hospital

    Toronto

    Helen MacKay

    Recruiting

  • BC Cancer Vancouver

    Vancouver

    Anna Tinker

    Recruiting

  • BC Cancer Victoria

    Victoria

    Jennifer Rauw

    Recruiting

Other trials in Canada

New Zealand2 sites, 2 recruiting

  • Auckland City Hospital

    Auckland

    Michelle Wilson

    Recruiting

  • Christchurch Hospital

    Christchurch

    Michelle Vaughan

    Recruiting

Other trials in New Zealand

About this study

Official title: 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

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.

Read the detailed description

ICON9 is an international multicentre randomised, phase III trial assessing maintenance treatment with olaparib and cediranib or olaparib alone in women with relapsed ovarian cancer whose disease progressed more than 6 months after first line chemotherapy. Women whose disease responds to platinum chemotherapy following 3 to 4 cycles can be registered for collection of germline BRCA test results if known, and somatic BRCA testing of archival tumour specimens or secondary debulking tissue if required. Patients who have completed treatment and whose disease has responded (partial or complete) to a minimum of 4 cycles of platinum based chemotherapy will be randomised to maintenance treatment of either olaparib and cediranib or olaparib alone.

The maintenance regimen may be continued beyond radiological progression until trial closure if the patient is deemed to still be deriving clinical benefit, but must be discontinued once subsequent treatment is instituted.

Conditions
Ovarian Cancer
Being tested
Olaparib, Cediranib
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OlaparibDrug

    Olaparib is a PARP inhibitor, targeting DNA repair processes.

  • CediranibDrug

    Cediranib is an inhibitor of vascular endothelial growth factor-A (VEGF), targeting angiogenesis.

Study groups in NCT03278717
Study groupRoleWhat they receive
Olaparib and CediranibExperimentalPatients 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.
Receives: Drug: Olaparib; Drug: Cediranib
OlaparibActive 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.
Receives: Drug: Olaparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 years

Secondary outcomes (9)

  1. Toxicity

    Toxicity (AEs) experienced by patients as assessed by the Common Terminology Criteria for Adverse Events v4.03

    Measured: 3 years

  2. PFS and OS measured from the time of starting chemotherapy

    PFS and OS measured from the time of starting chemotherapy

    Measured: 3 years

  3. Adherence to maintenance therapy- compliance and dose reductions and interruptions

    Adherence to maintenance therapy- compliance and dose reductions and interruptions

    Measured: 3 years

  4. TSST (the time from randomisation to start of second subsequent therapy or death)

    TSST (the time from randomisation to start of second subsequent therapy or death)

    Measured: 3 years

  5. Quality of life using EORTC QLQ C30

    Quality of life using EORTC QLQ C30

    Measured: 3 years

  6. Quality of life using EORTC QLQ OV28

    Quality of life using EORTC QLQ OV28

    Measured: 3 years

  7. Cost effectiveness using EQ-5D-5L for economic evaluation

    Cost effectiveness using EQ-5D-5L for economic evaluation

    Measured: 3 years

  8. VIII. Response rate (RECIST v1.1 and/or CA125) at 16 weeks of treatment in patients who had RECIST v1.1 measurable disease or elevated CA125 at randomisation. RECIST measurements will be based on investigator assessment not central review

    VIII. Response rate (RECIST v1.1 and/or CA125) at 16 weeks of treatment in patients who had RECIST v1.1 measurable disease or elevated CA125 at randomisation. RECIST measurements will be based on investigator assessment not central review

    Measured: 3 years

  9. Overall survival (OS) measured from the date of randomisation to the date of death from any cause

    Overall survival (death from any cause) measured from the time of randomisation.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2017
  2. Study start15 Jun 2018
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03278717
Sponsor's protocol ID
UCL/14/0795
Acronym
ICON9
Status last verified
Jun 2022
First submitted
31 Jul 2017
Last updated
27 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37185961

  • Elyashiv 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.

    PubMed 33097567

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Olaparib and Cediranib in people with Ovarian Cancer, run by University College, London at 54 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United Kingdom, Australia, Canada, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ian Macdonald (+44 (0)20 7679 9808, ctc.ICON9@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03278717, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.

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