To Assess the Efficacy and Safety of Olaparib Maintenance Monotherapy in the Treatment of Ovarian… (NCT02476968) | Clinical Trial Compass
CompletedPhase 4
To Assess the Efficacy and Safety of Olaparib Maintenance Monotherapy in the Treatment of Ovarian Cancer
Bulgaria181 participantsStarted 2015-09-28
Plain-language 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 \[known or predicted to be detrimental/lead to loss of function\]).
Who can participate
Age range18 Years – 130 Years
SexFEMALE
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Inclusion criteria
✓. Provision of informed consent prior to any study specific procedures
✓. Age 18 years or over
✓. Documented germline or somatic mutation in BRCA1 or BRCA2 genes that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function) \[Genetic counselling for patients with germline BRCA mutations should be performed according to local regulations\] Or Tumour BRCAwt status and documented qualifying mutation in any of 13 genes involved in the HRR pathway, excluding BRCA1 and BRCA2 (ATM, BARD1, BRIP1,CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D,and RAD54L), identified by the Lynparza HRR Assay in archival tumour tissue (i.e.,BRCA-independent HRRm)
✓. Patients with platinum sensitive relapsed high grade epithelial ovarian cancers (including primary peritoneal and/or fallopian tube cancer):
✓. Patients should have received at least 2 previous lines of platinum containing therapy prior to enrolment:
✓. Patients must have normal organ and bone marrow function measured within 28 days of enrolment, as defined below:
✓. Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase \[SGOT\]) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase \[SGPT\]) ≤ 2.5 x institutional ULN unless liver metastases are present in which case they must be ≤ 5x ULN
What they're measuring
1
Progression-Free Survival (PFS)
Timeframe: Tumour assessments at baseline then every 12 weeks relative to date of enrolment until RECIST 1.1-defined progression. Assessed until primary analysis DCO of 17 April 2020 (up to maximum of 55 months).
✕. Patients previously diagnosed with gBRCAm disease
✕. Participation in another clinical study with an investigational product during the most recent chemotherapy course
✕. Patients with a known hypersensitivity to olaparib or any of the excipients of the product
✕. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) or major surgery within 3 weeks prior to olaparib treatment. Major surgery within 3 weeks of starting study treatment and patients must have recovered from any effects of any major surgery
✕. Persistent toxicities Common Terminology Criteria for Adverse Event (CTCAE) grade 2 caused by previous cancer therapy, excluding alopecia
✕. Patients with myelodysplastic syndrome/acute myeloid leukaemia
✕. Immuno-compromised patients e.g., Human Immunodeficiency Virus (HIV) requiring treatment or active Hepatitis B or C
✕. Patients with symptomatic uncontrolled brain metastases. 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 (SD) for 28 days