D0816C00012 (ORZORA), Open Label, Phase IV, Ovarian Cancer (Olaparib)

• Research type

  Research Study

• Full title

  An Open Label, Single Arm, Multicentre Study to Assess the Clinical Effectiveness and Safety of Lynparza (Olaparib) Capsules Maintenance Monotherapy in Platinum Sensitive Relapsed somatic or germline BRCA Mutated Ovarian Cancer Patients who are in Complete or Partial Response Following Platinum based Chemotherapy (ORZORA)

• IRAS ID

  177196

• Contact name

  Geoffrey David Hall

• Contact email

  geoff.hall2@nhs.net

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2015-000734-30

• Duration of Study in the UK

  3 years, 7 months, 1 days

• Research summary

  Summary of Research
  This is an Open Label, Phase IV study of Lynparza (also known as Olaparib, the study drug) in participants with BRCA (breast cancer) mutated ovarian cancer who have already received platinum based chemotherapy. The study drug has received marketing regulatory approval and this study will investigate the safety and effectiveness of the drug as a stand-alone treatment as per the EU approved prescribing information.

  Participants will receive the study drug as oral 400mg capsules twice daily (800mg in total, as 16 50mg capsules per day) within 8 weeks of their final chemotherapy treatment.

  Approximately 500 participants will be enrolled from 150 sites across 20 countries worldwide.

  The study consists of a screening visit (up to 56 days depending on whether the participants BRCA status is known or unknown), followed by an enrolment visit and then treatment visits 28 days apart coupled with 12 weekly tumour assessments until disease progress and the participant stops taking the study drug and then a follow up period including a safety follow-up visit 30 days after the last dose of the study drug.

  Summary of Results
  Maintenance therapy with olaparib capsules demonstrated consistent clinical activity on Investigator-assessed progression free survival by modified RECIST version 1.1 in BRCAm and sBRCAm

  platinum sensitive relapsed ovarian cancer patients.

  Certain prognostic factors such as complete response and no evidence of disease at baseline status were found to influence the PFS.

  QoL of patients was maintained during the treatment period, with no clinically meaningful detriments observed across treatment visits and similar results for the BRCAm cohort and the sBRCAm and gBRCAm patients.

  The safety and tolerability of olaparib observed in this study was generally consistent in the BRCAm, sBRCAm and gBRCAm patients, the HRRm^ cohort, and the total patient population, and was in line with the known safety profile of olaparib used in monotherapy.

  Patients from the HRRm^ cohort had baseline characteristics and clinical outcomes comparable to those of patients with BRCAm disease
  Has the registry been updated to include summary results?: No
  If yes - please enter the URL to summary results:
  If no – why not?: Results will be posted after sponsor’s signature: https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Furl6570.hra.nhs.uk%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agba4yu73OCS9U-2BkKS40W1kfZLMhYNSL6uAQ3D-2BHysQkrDCr74ROuLuWr8w9DMQddSbQ-3D-3Dd68x_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YJ-2Bp3tO-2BPla-2BX-2BLiCClBG4n-2Bs0mJAuS9r3v5Ow6JcaocPnY9lzuoRDifrqW5KNZc8IH-2BmIxKyAtFYU-2Fk9lk21b03DcvmrJUCyIK1HHvhxTPsiMXCkIMXKdHOQV8Ck9j9TEk-2B7DrtRiZdHSqX-2BPwgcJEV3QtSQJ9s7h8KcNUnSPpBA-3D-3D&data=04%7C01%7Capprovals%40hra.nhs.uk%7C84ee558559fe4aeaed9108da2148224a%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637858890938538160%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=z4yD7fiI2g7uYkhDXjbDMr%2BJSyVkCT79kQ%2Bpusn7uew%3D&reserved=0

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  15/SC/0295

• Date of REC Opinion

  10 Jul 2015

• REC opinion

  Further Information Favourable Opinion