To Assess the Efficacy and Safety of Olaparib Maintenance Monotherapy in the Treatment of Ovarian Cancer
Condition: BRCA or HRR+ Mutated Ovarian Cancer Patients
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective, open-label, single arm, multi-center study to assess the real world
      clinical effectiveness and safety of olaparib maintenance monotherapy as the capsule
      formulation (in line with the EU approved prescribing information) and will be conducted in
      platinum-sensitive relapsed high grade epithelial ovarian cancer patients (including patients
      with primary peritoneal and / or fallopian tube cancer) who carry germline or somatic BRCA
      mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or
      suspected deleterious [known or predicted to be detrimental/lead to loss of function]).
    

Detailed description: 
      The study will recruit approximately 250 patients with sBRCAm disease or gBRCAm disease, with
      the aim to accrue a minimum of 50 patients with sBRCAm disease.

      Patients with an unknown germline BRCA mutated status or gBRCAwt disease or previously
      identified as having a BRCAm disease by a tumour test will be considered for screening and
      will undergo, upon informed consent signature, central tumor and blood testing to determine
      their BRCA mutation status. In addition to central BRCA testing, patients screened for the
      study with unknown BRCA status or with known gBRCAwt status, for whom an adequate archival
      tumour tissue sample is available, will be tested for qualifying HRR gene alterations.
      Patients confirmed to carry a deleterious or suspected deleterious BRCA-independent genetic
      alteration in any of 13 genes involved in the Homologous Recombination Repair (HRR) pathway
      (HRRm cohort) will be allowed into an additional exploratory cohort (HRRm cohort). It is
      expected that approximately 25 patients will be included in the HRRm cohort before the target
      number of 250 patients with BRCAm disease is reached.

      Patients will be assigned olaparib capsules orally 400 mg twice daily. They should initiate
      olaparib treatment within 8 weeks after their last dose of platinum-containing chemotherapy
      (last dose is the day of the last infusion) and will be assessed every 4 weeks whilst on
      treatment.

      All patients will have clinical and objective radiological tumour assessments according to
      modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines at baseline and
      every 12 weeks relative to date of enrolment, until objective radiological disease
      progression as determined by the investigator. Patients could continue to receive olaparib
      for as long as determined by the investigator, until objective radiological disease
      progression or as long as in the investigator's opinion they are benefiting from treatment in
      relation to other clinical assessments and they do not meet any other discontinuation
      criteria. Once a patient has discontinued olaparib she will be managed as per local clinical
      practice but will remain in the study and data will be collected on subsequent treatments,
      progression, overall survival and safety.

      For exploratory analysis purposes, patients will be asked to provide consent to:

        1. Optional tumour samples at baseline and at disease progression

        2. An optional blood sample only for patients with a confirmed sBRCAm or HRRm disease
    

Intervention name(s): Olaparib
Intervention type(s): Drug
Intervention description(s): Olaparib Capsule - 50 mg. Olaparib capsules will be packed in high-density polyethylene (HDPE) bottles with child-resistant closures. Each bottle will contain 120 capsules and 4 bottles will be dispensed for a 4 weekly visit, with a 2 day overage.
Patients will be administered olaparib capsules orally at a dose of 400 mg twice daily.
Eight 50 mg olaparib capsules should be taken at the same time each day approximately 12 hours apart with approximately 240 mL of water.
Other intervention name(s): Lynparza
Intervention MeSH terms: Olaparib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other