<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03278717</url>
  </required_header>
  <id_info>
    <org_study_id>UCL/14/0795</org_study_id>
    <nct_id>NCT03278717</nct_id>
  </id_info>
  <brief_title>Study Evaluating the Efficacy of Maintenance Olaparib and Cediranib or Olaparib Alone in Ovarian Cancer Patients</brief_title>
  <acronym>ICON9</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University College, London</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      ICON 9 will assess the efficacy, safety and tolerability of maintenance olaparib in&#xD;
      combination with cediranib compared to maintenance olaparib alone following a response to&#xD;
      platinum-based chemotherapy in women with relapsed platinum-sensitive ovarian, fallopian tube&#xD;
      or peritoneal cancer. Prognostic and predictive factors will be studied from tumour and blood&#xD;
      samples.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ICON9 is an international multicentre randomised, phase III trial assessing maintenance&#xD;
      treatment with olaparib and cediranib or olaparib alone in women with relapsed ovarian cancer&#xD;
      whose disease progressed more than 6 months after first line chemotherapy. Women whose&#xD;
      disease responds to platinum chemotherapy following 3 to 4 cycles can be registered for&#xD;
      collection of germline BRCA test results if known, and somatic BRCA testing of archival&#xD;
      tumour specimens or secondary debulking tissue if required. Patients who have completed&#xD;
      treatment and whose disease has responded (partial or complete) to a minimum of 4 cycles of&#xD;
      platinum based chemotherapy will be randomised to maintenance treatment of either olaparib&#xD;
      and cediranib or olaparib alone.&#xD;
&#xD;
      The maintenance regimen may be continued beyond radiological progression until trial closure&#xD;
      if the patient is deemed to still be deriving clinical benefit, but must be discontinued once&#xD;
      subsequent treatment is instituted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 15, 2018</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <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)</measure>
    <time_frame>3 years</time_frame>
    <description>Progression free survival (PFS) measured from the time of randomisation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Toxicity</measure>
    <time_frame>3 years</time_frame>
    <description>Toxicity (AEs) experienced by patients as assessed by the Common Terminology Criteria for Adverse Events v4.03</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS and OS measured from the time of starting chemotherapy</measure>
    <time_frame>3 years</time_frame>
    <description>PFS and OS measured from the time of starting chemotherapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to maintenance therapy- compliance and dose reductions and interruptions</measure>
    <time_frame>3 years</time_frame>
    <description>Adherence to maintenance therapy- compliance and dose reductions and interruptions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TSST (the time from randomisation to start of second subsequent therapy or death)</measure>
    <time_frame>3 years</time_frame>
    <description>TSST (the time from randomisation to start of second subsequent therapy or death)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life using EORTC QLQ C30</measure>
    <time_frame>3 years</time_frame>
    <description>Quality of life using EORTC QLQ C30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life using EORTC QLQ OV28</measure>
    <time_frame>3 years</time_frame>
    <description>Quality of life using EORTC QLQ OV28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost effectiveness using EQ-5D-5L for economic evaluation</measure>
    <time_frame>3 years</time_frame>
    <description>Cost effectiveness using EQ-5D-5L for economic evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>3 years</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS) measured from the date of randomisation to the date of death from any cause</measure>
    <time_frame>3 years</time_frame>
    <description>Overall survival (death from any cause) measured from the time of randomisation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">330</enrollment>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>Olaparib and Cediranib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive oral olaparib 300mg BD and oral cediranib 20mg OD.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Olaparib</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive oral olaparib 300mg BD.&#xD;
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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Olaparib</intervention_name>
    <description>Olaparib is a PARP inhibitor, targeting DNA repair processes.</description>
    <arm_group_label>Olaparib</arm_group_label>
    <arm_group_label>Olaparib and Cediranib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cediranib</intervention_name>
    <description>Cediranib is an inhibitor of vascular endothelial growth factor-A (VEGF), targeting angiogenesis.</description>
    <arm_group_label>Olaparib and Cediranib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Registration Inclusion Criteria:&#xD;
&#xD;
          1. Provision of informed consent prior to any study specific procedures and the ability&#xD;
             to comply with the protocol for the duration of the study, including undergoing&#xD;
             treatment and scheduled visits and examinations.&#xD;
&#xD;
          2. Females aged ≥ 18 years with previous histologically proven diagnosis of high grade&#xD;
             serous or endometrioid carcinoma of the&#xD;
&#xD;
               -  Ovary&#xD;
&#xD;
               -  Fallopian tube&#xD;
&#xD;
               -  or peritoneum, progressing &gt;6 months after day 1 of the last cycle of first-line&#xD;
                  platinum-based chemotherapy and requiring treatment with platinum-based&#xD;
                  chemotherapy on the basis of radiological evidence of disease or following&#xD;
                  surgical resection of recurrent disease.&#xD;
&#xD;
          3. Patients must have had CT or MRI proven relapsed disease (measureable or&#xD;
             non-measureable abnormalities supported by GCIG CA125 criteria of progression), or&#xD;
             have had debulking surgery for first relapse.&#xD;
&#xD;
          4. Patients showing evidence of response to chemotherapy mid-treatment (post 3 or 4&#xD;
             cycles), either by CA125 or CT/MRI scan, should be approached for ICON9 trial&#xD;
             registration to allow for BRCA mutation status to be assessed (germline and/ or&#xD;
             somatic). Patients who underwent surgical debulking must show no evidence of disease&#xD;
             progression by the assessments above (CA125 and CT/MRI scan) in order to be approached&#xD;
             for registration.&#xD;
&#xD;
          5. Prior front-line maintenance therapy with bevacizumab is permitted.&#xD;
&#xD;
          6. ECOG performance status 0-1.&#xD;
&#xD;
          7. Formalin fixed, paraffin embedded (FFPE) archival/diagnostic tumour sample or from&#xD;
             secondary debulking surgery with adequate neoplastic cell content (&gt;30%), must be&#xD;
             available for central BRCA testing. For inclusion in i) the genetic HRD Test and ii)&#xD;
             the biomarker research, patients must complete the consent form. Translational blood&#xD;
             samples are also required, see Laboratory Manual for further details.&#xD;
&#xD;
          8. Patients should have a life expectancy ≥ 16 weeks.&#xD;
&#xD;
          9. Postmenopausal or evidence of non-childbearing status for women of childbearing&#xD;
             potential: negative urine or serum pregnancy test within 28 days prior to study&#xD;
             treatment and confirmed prior to treatment on day 1.&#xD;
&#xD;
             Postmenopausal is defined as age ≥60 years, or:&#xD;
&#xD;
               -  Amenorrheic for 1 year or more following cessation of exogenous hormonal&#xD;
                  treatments&#xD;
&#xD;
               -  Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the&#xD;
                  post-menopausal range for women under 50&#xD;
&#xD;
               -  Radiation-induced oophorectomy with last menses &gt;1 year ago&#xD;
&#xD;
               -  Chemotherapy-induced menopause with &gt;1 year interval since last menses&#xD;
&#xD;
               -  Surgical sterilisation (bilateral oophorectomy or hysterectomy)&#xD;
&#xD;
         10. Adequately controlled blood pressure (systolic blood pressure [SBP] ≤140 mmHg;&#xD;
             diastolic blood pressure [DBP] ≤ 90mmHg) on maximum of 2 antihypertensive medications.&#xD;
&#xD;
         11. Adequately controlled thyroid function, with no symptoms of thyroid dysfunction.&#xD;
&#xD;
        Randomisation Inclusion Criteria:&#xD;
&#xD;
          1. Patients must have received at least 4 cycles, and a maximum of 6 cycles of&#xD;
             second-line platinum-based chemotherapy.&#xD;
&#xD;
          2. In patients with measurable disease, end of treatment scans must have a RECIST v1.1&#xD;
             'partial response' or 'complete response' and meet one of the following CA125&#xD;
             requirements:&#xD;
&#xD;
               1. If the first screening CA125 value is below the ULN the patient is eligible for&#xD;
                  randomisation and a second CA125 assessment is not required.&#xD;
&#xD;
               2. If the first screening CA125 value is greater than ULN then a second assessment&#xD;
                  is required at least 7 days after the first to confirm eligibility. If the second&#xD;
                  CA125 value has risen by ≥ 15% then the patient will not be eligible.&#xD;
&#xD;
          3. In patients with non-measurable disease, who have not undergone debulking surgery,&#xD;
             they must have had a GCIG CA125 response to chemotherapy and meet one of the following&#xD;
             CA125 requirements:&#xD;
&#xD;
               1. If the first screening CA125 value is below the ULN the patient is eligible for&#xD;
                  randomisation and a second CA125 assessment is not required.&#xD;
&#xD;
               2. If the first screening CA125 value is greater than ULN then a second assessment&#xD;
                  is required at least 7 days after the first to confirm eligibility. If the second&#xD;
                  CA125 value has risen by ≥ 15% then the patient will not be eligible.&#xD;
&#xD;
          4. Patients who have had debulking surgery at first relapse must have no evidence of&#xD;
             disease progression on imaging (CT or MRI) and meet one of the following CA125&#xD;
             requirements:&#xD;
&#xD;
               1. If the first screening CA125 value is below the ULN the patient is eligible for&#xD;
                  randomisation and a second CA125 assessment is not required.&#xD;
&#xD;
               2. If the first screening CA125 value is greater than ULN then a second assessment&#xD;
                  is required at least 7 days after the first to confirm eligibility. If the second&#xD;
                  CA125 value has risen by ≥ 15% then the patient will not be eligible.&#xD;
&#xD;
          5. Expected to be able to commence treatment within 7 days post randomisation, and within&#xD;
             4-8 weeks post day 1 of the last cycle of chemotherapy.&#xD;
&#xD;
          6. Adequate bone marrow function as defined below:&#xD;
&#xD;
               -  Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/l&#xD;
&#xD;
               -  Platelet (Plt) ≥ 90 x 109/l&#xD;
&#xD;
               -  Haemoglobin (Hb) ≥ 100g/l required and no packed blood transfusions in the 14&#xD;
                  days prior to starting trial treatment&#xD;
&#xD;
          7. Adequate liver function as defined below:&#xD;
&#xD;
               -  Serum bilirubin ≤ 1.5 x ULN (or ≤ 3 for cases of known Gilbert's syndrome)&#xD;
&#xD;
               -  Serum transaminases ≤3 x ULN&#xD;
&#xD;
               -  Serum transaminases ≤ 5 x ULN if liver metastasis present&#xD;
&#xD;
          8. Adequate renal function as defined below:&#xD;
&#xD;
             • Serum creatinine ≤ 1.5 x ULN and calculated glomerular filtration rate (GFR)&#xD;
             ≥50ml/min (calculated as per local practice using Wright or Cockroft-gault formula)&#xD;
&#xD;
          9. Urine dipstick for proteinuria &lt;2+. If urine dipstick is ≥ 2+ on two occasions more&#xD;
             than one week apart then a 24-hour urine must demonstrate ≤ 1 g of protein in 24 hours&#xD;
             or protein/creatinine ratio &lt; 1.5.&#xD;
&#xD;
         10. Adequately controlled blood pressure (systolic blood pressure [SBP] ≤140 mmHg;&#xD;
             diastolic blood pressure [DBP] ≤ 90mmHg) on maximum of 2 antihypertensive medications.&#xD;
&#xD;
         11. Germline and/or somatic BRCA mutation status must be known prior to randomisation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Non-epithelial ovarian cancer, carcinosarcoma, clear cell carcinoma and mucinous&#xD;
             carcinomas.&#xD;
&#xD;
          2. Arterial thrombotic event (including transient ischemic attack, cerebrovascular&#xD;
             accident, and peripheral arterial embolus) within the last 12 months.&#xD;
&#xD;
          3. Patients unable to swallow orally administered medication and patients with&#xD;
             gastrointestinal impairment that could affect ability to take, or absorption of oral&#xD;
             medicines including sub-acute or complete bowel obstruction.&#xD;
&#xD;
          4. Clinically significant signs and/or symptoms of bowel obstruction within 3 months&#xD;
             prior to starting treatment.&#xD;
&#xD;
          5. History of intra-abdominal abscess within 3 months prior to starting treatment&#xD;
             (randomisation).&#xD;
&#xD;
          6. History of GI perforation. Patients with a history of abdominal fistula will be&#xD;
             considered eligible if the fistula was surgically repaired, there has been no evidence&#xD;
             of fistula for at least 6 months prior to starting treatment, and patient is deemed to&#xD;
             be at low risk of recurrent fistula.&#xD;
&#xD;
          7. Symptomatic or clinically significant inflammatory bowel disease (Crohn's disease or&#xD;
             ulcerative colitis).&#xD;
&#xD;
          8. Patients with an ileostomy will be excluded.&#xD;
&#xD;
          9. Evidence of severe or uncontrolled cardiac disease.&#xD;
&#xD;
               1. Myocardial infarct or unstable angina within the last 6 months&#xD;
&#xD;
               2. New York Health Association (NHYA) ≥ grade 2 congestive heart failure&#xD;
&#xD;
               3. Cardiac ventricular arrhythmias requiring medication&#xD;
&#xD;
               4. History of 2nd or 3rd degree atrioventricular conduction defects&#xD;
&#xD;
         10. Resting ECG with QTcF &gt; 470msec on 2 or more time points within a 24 hour period or&#xD;
             family history of long QT syndrome.&#xD;
&#xD;
         11. Evidence of active bleeding or bleeding diathesis.&#xD;
&#xD;
             Significant haemorrhage of &gt;30ml in a single episode within the last 3 months or any&#xD;
             haemoptysis (&gt;5ml fresh blood in last 4 weeks).&#xD;
&#xD;
         12. Malignancy treated within the last 5 years except: adequately treated non-melanoma&#xD;
             skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ&#xD;
             (DCIS) of the breast, Stage 1, grade 1 endometrial carcinoma.&#xD;
&#xD;
         13. Previous treatment with VEGFR tyrosine kinase inhibitors or PARP inhibitors are not&#xD;
             permitted.&#xD;
&#xD;
         14. Patients with a known hypersensitivity to excipients of cediranib or olaparib.&#xD;
&#xD;
         15. Persisting ≥ grade 2 CTCAE toxicity (except alopecia and neuropathy) from previous&#xD;
             anti-cancer treatment.&#xD;
&#xD;
         16. Major surgery within 14 days before anticipated start of treatment and patients must&#xD;
             have recovered from any effects of major surgery.&#xD;
&#xD;
         17. Inability to attend or comply with treatment or follow-up scheduling.&#xD;
&#xD;
         18. Evidence of any other disease, metabolic dysfunction, physical examination finding or&#xD;
             laboratory finding giving reasonable suspicion of a disease or condition that&#xD;
             contra-indicated the use of an investigation drug or puts the patients at high risk&#xD;
             for treatment-related complications.&#xD;
&#xD;
         19. Pregnant or breast-feeding women are excluded. Women of childbearing potential will be&#xD;
             excluded unless effective methods of contraception are used from signing of the&#xD;
             informed consent, throughout the period of taking study treatment and for at least 6&#xD;
             weeks after last dose of trial drug(s).&#xD;
&#xD;
         20. Treatment with any other investigational agent, or participation in another&#xD;
             interventional clinical trial within 28 days prior to enrolment (randomisation).&#xD;
&#xD;
         21. Concomitant use of known strong CYP3A4 inhibitors (such as systemic ketoconazole,&#xD;
             itraconazole, protease inhibitors boosted with ritonavir or cobicistat, indinavir,&#xD;
             saquinavir, nelfinavir, boceprevir, telaprevir, telithromycin and clarithromycin or&#xD;
             moderate CYP3A inhibitors (e.g. systemic Ciprofloxacin, erythromycin, diltiazem,&#xD;
             fluconazole, verapamil). The required washout period prior to starting olaparib is 2&#xD;
             weeks.&#xD;
&#xD;
         22. Concomitant use of known strong (e.g. phenobarbital, enzalutamide, phenytoin,&#xD;
             rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or&#xD;
             moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout&#xD;
             period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3&#xD;
             weeks for other agents.&#xD;
&#xD;
         23. Patients with myelodysplastic syndrome/acute myeloid leukaemia.&#xD;
&#xD;
         24. Other psychological, psychiatric, social or medical condition, physical examination&#xD;
             finding or a laboratory abnormality that the Investigator considers would make the&#xD;
             patient a poor trial candidate or could interfere with protocol compliance or the&#xD;
             interpretation of trial results.&#xD;
&#xD;
         25. Patients with known active hepatitis (i.e. Hepatitis B or C) due to risk of&#xD;
             transmitting the infection through blood or other body fluids.&#xD;
&#xD;
         26. Immunocompromised patients e.g., patients who are known to be serologically positive&#xD;
             for human immunodeficiency virus (HIV) and are receiving antiviral therapy.&#xD;
&#xD;
         27. Patients with symptomatic uncontrolled brain or meningeal metastases. A scan to&#xD;
             confirm the absence of brain metastases is not required. The patient can receive a&#xD;
             stable dose of corticosteroids before and during the study as long as these were&#xD;
             started at least 4 weeks prior to treatment.&#xD;
&#xD;
         28. Patients with spinal cord compression unless considered to have received definitive&#xD;
             treatment for this and evidence of clinically stable disease for 28 days.&#xD;
&#xD;
         29. Previous allogenic bone marrow transplant or double umbilical cord blood&#xD;
             transplantation (dUCBT).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ian Macdonald</last_name>
    <phone>+44 (0)20 7679 9808</phone>
    <email>ctc.ICON9@ucl.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mandy Feeney</last_name>
    <phone>+44 (0)20 7679 9890</phone>
    <email>ctc.ICON9@ucl.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Calvary Mater Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Janine Lombard</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Campbelltown Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Felicia Roncolato</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Michael Friedlander</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Hobart Hospital</name>
      <address>
        <city>Hobart</city>
        <state>Tasmania</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Allison Black</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Border Medical Oncology</name>
      <address>
        <city>Albury</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Christopher Steer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Flinders Medical Centre</name>
      <address>
        <city>Bedford Park</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Ganessan Kichenadasse</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Pindara Private Hospital</name>
      <address>
        <city>Benowa</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Marco Matos</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chris O'Brien Lifehouse</name>
      <address>
        <city>Camperdown</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Michelle Harrison</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Canberra Hospital</name>
      <address>
        <city>Canberra</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Alison Davies</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Monash Health</name>
      <address>
        <city>Clayton</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Kate Webber</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gosford Hospital</name>
      <address>
        <city>Gosford</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Craig Kukard</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Peter MacCallum Cancer Centre</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Linda Mileshkin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>ICON Cancer Centre</name>
      <address>
        <city>South Brisbane</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jim Coward</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mater Cancer Centre</name>
      <address>
        <city>South Brisbane</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Catherine Shannon</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Townsville Hospital</name>
      <address>
        <city>Townsville</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Abhishek Joshi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Westmead Hospital</name>
      <address>
        <city>Westmead</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Paul Harnett</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Michael Kolinsky</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de L'Universite de Montreal</name>
      <address>
        <city>Montréal</city>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Diane Provencher</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Quebec</name>
      <address>
        <city>Québec</city>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Vincent Castonguay</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Stephanie Lheureux</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Hospital</name>
      <address>
        <city>Toronto</city>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Helen MacKay</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>BC Cancer Vancouver</name>
      <address>
        <city>Vancouver</city>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Anna Tinker</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>BC Cancer Victoria</name>
      <address>
        <city>Victoria</city>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jennifer Rauw</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital</name>
      <address>
        <city>Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Michelle Wilson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Christchurch Hospital</name>
      <address>
        <city>Christchurch</city>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Michelle Vaughan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Furness General Hospital</name>
      <address>
        <city>Barrow In Furness</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Sarah Moon</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Belfast City Hospital</name>
      <address>
        <city>Belfast</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Royal Sussex County Hospital</name>
      <address>
        <city>Brighton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Rebecca Herbertson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Addenbrookes Hospital</name>
      <address>
        <city>Cambridge</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Joo Ern Ang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kent &amp; Canterbury Hospital</name>
      <address>
        <city>Canterbury</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Justin Waters</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Velindre Cancer Centre</name>
      <address>
        <city>Cardiff</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Louise Hanna</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cheltenham General Hospital</name>
      <address>
        <city>Cheltenham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Audrey Cook</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital Coventry</name>
      <address>
        <city>Coventry</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Lucy McAven</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ninewells Hospital</name>
      <address>
        <city>Dundee</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Michelle Ferguson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Western General Hospital</name>
      <address>
        <city>Edinburgh</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Charlie Gourley</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Beatson West of Scotland Cancer Centre</name>
      <address>
        <city>Glasgow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Ros Glasspool</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Surrey County Hospital</name>
      <address>
        <city>Guildford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Agnieszka Michael</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Lancaster Infirmary</name>
      <address>
        <city>Lancaster</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Sarah Moon</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Guy's Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Ana Montes</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hammersmith Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Laura Tookman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mount Vernon Cancer Centre</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Ignacio Vazquez</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Marsden NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Susanna Banerjee</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University College London Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jonathan Ledermann</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Christie Hospital</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Gordon Jayson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth the Queen Mother Hospital</name>
      <address>
        <city>Margate</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Justin Waters</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Churchill Hospital</name>
      <address>
        <city>Oxford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Shibani Nicum</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Queen Alexandra Hospital</name>
      <address>
        <city>Portsmouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Royal Berkshire Hospital</name>
      <address>
        <city>Reading</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Madhumita Battacharyya</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Southampton General Hospital</name>
      <address>
        <city>Southampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Clare Green</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lister Hospital</name>
      <address>
        <city>Stevenage</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Ignacio Vazquez</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Singleton Hospital</name>
      <address>
        <city>Swansea</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Rachel Jones</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Musgrove Park Hospital</name>
      <address>
        <city>Taunton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Emma Cattell</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Cornwall</name>
      <address>
        <city>Truro</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>John McGrane</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Clatterbridge Cancer Centre</name>
      <address>
        <city>Wirral</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Danielle Shaw</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>New Zealand</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 26, 2022</last_update_submitted>
  <last_update_submitted_qc>September 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Olaparib</mesh_term>
    <mesh_term>Cediranib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03278717
org study id: UCL/14/0795
nct id: NCT03278717
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
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
description: Progression free survival (PFS) measured from the time of randomisation.
measure: Toxicity
time frame: 3 years
description: Toxicity (AEs) experienced by patients as assessed by the Common Terminology Criteria for Adverse Events v4.03
measure: PFS and OS measured from the time of starting chemotherapy
time frame: 3 years
description: PFS and OS measured from the time of starting chemotherapy
measure: Adherence to maintenance therapy- compliance and dose reductions and interruptions
time frame: 3 years
description: Adherence to maintenance therapy- compliance and dose reductions and interruptions
measure: TSST (the time from randomisation to start of second subsequent therapy or death)
time frame: 3 years
description: TSST (the time from randomisation to start of second subsequent therapy or death)
measure: Quality of life using EORTC QLQ C30
time frame: 3 years
description: Quality of life using EORTC QLQ C30
measure: Quality of life using EORTC QLQ OV28
time frame: 3 years
description: Quality of life using EORTC QLQ OV28
measure: Cost effectiveness using EQ-5D-5L for economic evaluation
time frame: 3 years
description: Cost effectiveness using EQ-5D-5L for economic evaluation
measure: 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
time frame: 3 years
description: 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
measure: Overall survival (OS) measured from the date of randomisation to the date of death from any cause
time frame: 3 years
description: Overall survival (death from any cause) measured from the time of randomisation.
arm group label: Olaparib and Cediranib
arm group type: Experimental
description: Patients 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.
arm group label: Olaparib
arm group type: Active Comparator
description: Patients 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.
intervention type: Drug
intervention name: Olaparib
description: Olaparib is a PARP inhibitor, targeting DNA repair processes.
arm group label: Olaparib
arm group label: Olaparib and Cediranib
intervention type: Drug
intervention name: Cediranib
description: Cediranib is an inhibitor of vascular endothelial growth factor-A (VEGF), targeting angiogenesis.
arm group label: Olaparib and Cediranib
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ian Macdonald
phone: +44 (0)20 7679 9808
email: ctc.ICON9@ucl.ac.uk
last name: Mandy Feeney
phone: +44 (0)20 7679 9890
email: ctc.ICON9@ucl.ac.uk
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Terminated
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
country: Australia
country: Canada
country: New Zealand
country: United Kingdom
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Olaparib
mesh term: Cediranib
sharing ipd: No