Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer Patients
Condition: Non-Germline BRCA Mutated Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Olaparib
Intervention description: 300 mg twice daily - oral
Intervention MeSH terms: Olaparib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Single arm study
Masking: None (Open Label)
Masking description: Open
Enrollment: 279.0
Sex: Female
Minimum age: 18 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: Ovarian cancer; non-gBRCA; Platinum; Chemotherapy

Summary:

      The purpose of the study is to assess the efficacy and safety of single-agent olaparib as a
      maintenance treatment in patients with relapsed High Grade Serous Ovarian Cancer (including
      patients with primary peritoneal and/or fallopian tube cancer) or high grade endometrioid
      cancer who do not have known deleterious or suspected deleterious germline BRCA mutations
      (non-gBRCAm) and who had responded following platinum based chemotherapy
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Female patients with histologically diagnosed relapsed HGSOC (including primary
             peritoneal and / or fallopian tube cancer) or high grade endometrioid ovarian cancer

          -  Documented gBRCA1/2 mutation status

          -  Patients must have completed at least 2 previous courses of platinum containing
             therapy

          -  Patients must have normal organ and bone marrow function measured within 28 days of
             starting study treatment

          -  ECOG performance status 0-1 (see Appendix E)

          -  Patients must 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 of study treatment
             and confirmed prior to treatment on day 1

          -  At least one lesion (measurable and/or non-measurable) that can be accurately assessed
             at baseline with computed tomography (CT) or magnetic resonance imaging (MRI) and is
             suitable for repeated assessment OR No evidence of disease following a complete
             response to chemotherapy

          -  An appropriately prepared tumour sample from the cancer, of sufficient quantity and
             quality (as specified in the Central Laboratory Services Manual) must be available for
             future central testing of tumour genetic status

        Exclusion Criteria:

          -  Patients receiving any systemic hormonal therapy, chemotherapy or radiotherapy (except
             for palliative reasons) within 3 weeks prior to start of study treatment

          -  Any previous treatment with PARP inhibitor, including olaparib

          -  Patients with a germline BRCA mutation that is predicted to be deleterious or
             suspected deleterious (known or predicted to be detrimental / lead to loss of
             function)

          -  Other malignancy unless curatively treated with no evidence of disease for ≥5 years
             except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer
             of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial
             carcinoma.

          -  Concomitant use of known strong CYP3A inhibitors and strong (or moderate CYP3A
             inducers

          -  Persistent toxicities (≥ Grade 2 Common Terminology Criteria for Adverse Event (CTCAE)
             adverse event) caused by previous cancer therapy, excluding alopecia

          -  Patients with myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) or with
             features suggestive of MDS/AML

          -  Patients with symptomatic uncontrolled brain metastases