Olaparib Treatment in Relapsed Germline Breast Cancer Susceptibility Gene (BRCA) Mutated Ovarian Cancer Patients Who Have Progressed at Least 6 Months After Last Platinum Treatment and Have Received at Least 2 Prior Platinum Treatments.

Official Title

A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physician's Choice Single Agent Chemotherapy in the Treatment of Platinum Sensitive Relapsed Ovarian Cancer in Patients Carrying Germline BRCA1/2 Mutations.

Summary:

Comparison of olaparib vs. physician's choice of single agent standard of care non-platinum based chemotherapy in patients with germline Breast Cancer susceptibility gene (gBRCA) mutated ovarian cancer who have progressed at least 6 months after the last platinum based chemotherapy. Patient should have received at least 2 prior lines of platinum based chemotherapy. The aim of the study is to assess the efficacy and safety of olaparib tablets.

Trial Description

Primary Outcome:

  • Progression Free Survival (PFS) by blinded independent central review using Response Evaluation Criteria In Solid Tumours (RECIST) data
Secondary Outcome:
  • Efficacy of olaparib vs. physician's choice single agent chemotherapy by assessment of Overall Survival (OS)
  • Efficacy in patients following platinum based chemotherapy by assessment of time from randomisation to second progression
  • Efficacy in patients following platinum based chemotherapy by assessment of time to earliest progression by Cancer Antigen (CA-125) or death
  • Time to deterioration of Health-Related Quality of Life (HRQoL) as assessed by trial outcome index (TOI) and the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)
  • Efficacy in patients with a deleterious or suspected deleterious variant in either of the BRCA genes by assessment of PFS.
  • Efficacy of olaparib by time to first subsequent therapy or death (TFST).
  • Efficacy of olaparib by time to second subsequent therapy or death (TSST).
  • Efficacy of olaparib by time from randomisation to study treatment discontinuation or death (TDT).
  • Safety and tolerability of olaparib by assessment of the number of Adverse Events (AEs).
  • Safety and tolerability of olaparib by review of laboratory parameters, ECG and vital signs
  • Efficacy in patients following platinum based chemotherapy by assessment of time to earliest progression by RECIST or death
This open label, randomised, controlled, multi-centre study will assess the efficacy and safety of single agent olaparib vs. standard of care, based on physician's choice of single agent chemotherapy ( i.e paclitaxel, or topotecan, or pegylated liposomal doxorubicin, or gemcitabine) in platinum sensitive or partially platinum sensitive relapsed ovarian cancer patients who carry germline deleterious or suspected deleterious BRCA mutation and who have received at least 2 prior lines of platinum based chemotherapy. Patients are eligible to undergo BRCA testing even if they have not yet had recurrence or progression of disease >6 months (>/=183 days) after completion of their last platinum therapy.

View this trial on ClinicalTrials.gov

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Resources

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