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Poster display session

3047 - OCTOVA: A randomised phase II trial of olaparib, chemotherapy, or olaparib and cediranib in patients with BRCA-mutated platinum-resistant ovarian cancer

Date

09 Sep 2017

Session

Poster display session

Presenters

Shibani Nicum

Citation

Annals of Oncology (2017) 28 (suppl_5): v330-v354. 10.1093/annonc/mdx372

Authors

S. Nicum1, V.Y. Strauss2, N. McGregor3, I. McNeish4, R. Roux5, M. Hall6, A. Michael7, C. Roberts2

Author affiliations

  • 1 Department Of Oncology, Oxford University Hospitals NHS Foundation Trust, OX3 7LE - Oxford/GB
  • 2 Centre For Statistics In Medicine, University of Oxford, Oxford/GB
  • 3 Oncology Clinical Trials Office, Department Of Oncology, University of Oxford, Oxford/GB
  • 4 Institute Of Cancer Sciences, University of Glasgow, Glasgow/GB
  • 5 Department Of Oncology, Oxford University Hospitals NHS Foundation Trust, Oxford/GB
  • 6 Mount Vernon Cancer Centre, East and North Hertfordshire NHS Trust, Middlesex/GB
  • 7 Royal Surrey County Hospital, University of Surrey, Surrey/GB
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Resources

Abstract 3047

Background

Women with platinum resistant ovarian cancer (OC) have limited responses to standard therapy, and clinical trials with novel agents are therefore highly justified. Olaparib is a potent PARP inhibitor that has shown enhanced activity in women with relapsed BRCA-mutated OC in both platinum sensitive and resistant settings. Angiogenesis inhibitors, such as the oral tyrosine kinase inhibitor cediranib, are active in OC, and have shown additive effects when combined with PARP inhibitors preclinically, as hypoxia-induced downregulation of homologous recombination repair genes, BRCA1, 2 and RAD51 enhances PARP inhibitor sensitivity. Recent phase 2 trials in relapsed platinum-sensitive OC have also shown benefit from the combination of olaparib and cediranib compared to olaparib alone. The OCTOVA trial investigates the benefit of single agent olaparib compared to olaparib and cediranib or weekly paclitaxel in women with BRCA-mutated platinum-resistant OC.

Trial design

Eligible patients for OCTOVA are females aged ≥16 years with a germline or somatic BRCA1 or 2 mutation who have progressed within 6 months of previous platinum-based therapy. Patients may have received prior PARP inhibitor and antiangiogenic therapy, with at least a 6-month interval since treatment. 132 patients will be randomised, with stratification for prior PARP inhibitor exposure and prior anti-angiogenic therapy, to one of three treatment arms: paclitaxel (80mg/m2 weekly), olaparib (300mg twice daily), or cediranib (20mg once daily) and olaparib (300mg twice daily), until disease progression or unacceptable toxicity develops, and will be followed up for 18 months. Patients who progress on weekly paclitaxel will be permitted to crossover and receive single agent olaparib therapy. The primary analysis will compare the efficacy (as measured by progression-free survival) of olaparib compared to combination of olaparib and cediranib, and independently olaparib compared to paclitaxel. Secondary endpoints include safety and tolerability of the combination of olaparib and cediranib, overall survival, objective response rate, and quality of life outcomes.

Clinical trial identification

OCTO_062

Legal entity responsible for the study

University of Oxford

Funding

AstraZeneca (AZ)

Disclosure

S. Nicum: Consultant/Advisory Boards: Roche, AstraZeneca, Abbvie, Tesaro, Clovis Speaker: AstraZeneca, Roche Clinical Trials Sponsored: AstraZeneca. All other authors have declared no conflicts of interest.

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