Olaparib Maintenance Treatment Versus Placebo in Patients With PSR Ovarian Cancer Who Are in CR or PR to Platinum-based Chemotherapy and Whose Tumours Carry sBRCAm or HRR-associated Genes Mutations

Conditions

• Platinum Sensitive Relapsed Ovarian Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 96 Years

Healthy Volunteers

Not accepted

Interventions

• OLAPARIB — DRUG
  Patients should continue with therapy until objective radiological disease progression as per RECIST 1.1 despite rises in CA-125. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria
• PLACEBO — DRUG
  Patients should continue with therapy until objective radiological disease progression as per RECIST 1.1 despite rises in CA-125. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria

Study Details

Olaparib administered as monotherapy in the maintenance setting improves progression free survival compared to placebo in patients whose tumours carry loss of function (deleterious or suspected deleterious) somatic BRCA mutations or loss of function (deleterious or suspected deleterious) mutation in non-BRCA Homologous Recombination Repair (HRR) -associated genes who have a complete or partial response to platinum-based chemotherapy.

Key Dates

Start date

Jul 31, 2016

Status verified

Apr 2016

Primary completion

Jun 30, 2019

Completion

Jun 30, 2019

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 1/OLAPARIB
  olaparib 300 mg oral tablets; twice daily
• Placebo Comparator: 2/PLACEBO
  placebo matching olaparib 300 mg oral tablets; twice daily

Primary Outcome Measure

Progression Free Survival (PFS) using modified RECIST 1.1 in the cohort of patients with sBRCA ovarian cancer [ Time Frame: From date of randomization until the date of first documented progression or date of death (by any cause, in the absence of disease progression) whichever came first, assessed up to 40 months ]

Locations (15)

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