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Poster display session

2772 - ARIEL4: An International, Randomised Phase 3 Study of the PARP Inhibitor Rucaparib vs Chemotherapy for the Treatment of BRCA-Mutated, Relapsed, High-Grade Ovarian Cancer


09 Sep 2017


Poster display session


Cytotoxic Therapy;  Targeted Therapy;  Ovarian Cancer


Rebecca Kristeleit


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


R.S. Kristeleit1, D. Lorusso2, A. Oaknin3, T. Safra4, E.M. Swisher5, I.M. Bondarenko6, T. Huzarski7, J. Klat8, V. Moiseyenko9, R.L. Póka10, L.S. Viola11, C. Tankersley12, L. Maloney13, S. Goble14, C. Unger15, A. Dowson12, H. Giordano12, A.M. Oza16

Author affiliations

  • 1 Oncology, University College London Cancer Institute, WC1E 6BT - London/GB
  • 2 Gynecologic Oncology, MITO and Unità di Ginecologia Oncologica, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 3 Medical Oncology Department, Vall d'Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), 08035 - Barcelona/ES
  • 4 Oncology And Gynecology Service, Sackler School of Medicine, Tel Aviv University & Tel Aviv Sourasky Medical Center, 64239 - Tel Aviv/IL
  • 5 Department Of Obstetrics And Gynecology, University of Washington, Seattle/US
  • 6 Oncology, Dnipropetrovsk Medical Academy, City Multiple-Discipline Clinical Hospital, 49102 - Dnepropetrovsk/UA
  • 7 Department Of Medicine, Private Health Care Innovative Medicine, Grzepnica/PL
  • 8 Obstetrics And Gynecology, University Hospital Ostrava, Ostrava/CZ
  • 9 Oncology, NN. Petrov Research Institute of Oncology Cancer Center, 197758 - Saint Petersburg/RU
  • 10 Gynaecologic Oncology, Debrecen University Clinical Center, 4032 - Debrecen/HU
  • 11 Oncology, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre/BR
  • 12 Clinical Science, Clovis Oncology, Inc., Boulder/US
  • 13 Clinical Science, Clovis Oncology, Inc., 80301 - Boulder/US
  • 14 Biostatistics, Clovis Oncology, Inc., Boulder/US
  • 15 Clinical Operations, Clovis Oncology, Inc., Boulder/US
  • 16 Division Of Medical Oncology And Hematology, Princess Margaret Cancer Centre, University Health Network, M5G 1Z5 - Toronto/CA


Abstract 2772


Approximately 18% of patients (pts) with high-grade epithelial ovarian cancer (OC) harbour a deleterious germline BRCA1 or BRCA2 (BRCA1/2) mutation, and ≈7% harbour a somatic BRCA1/2 mutation (Pennington et al. Clin Cancer Res. 2014;20:764-75). The poly(ADP-ribose) polymerase (PARP) inhibitor rucaparib is approved in the United States for the treatment of pts with deleterious BRCA mutation (germline and/or somatic) associated advanced OC who have been treated with ≥2 chemotherapies. Data comparing PARP inhibitors to standard of care (SOC) treatment for relapsed OC are limited. Randomised studies are needed to assess the benefit-risk profile of PARP inhibitors vs SOC as treatment for BRCA1/2-mutated, relapsed, high-grade OC.

Trial design

ARIEL4 (EudraCT 2016-000816-14; NCT02855944) is evaluating rucaparib vs SOC chemotherapy as treatment for pts (n≈345) with relapsed, high-grade OC (regardless of histology) and a deleterious germline or somatic BRCA1/2 mutation who received ≥2 prior chemotherapy regimens. Pts stratified by progression-free interval after their most recent platinum regimen will be randomised 2:1 to receive rucaparib (600 mg BID) (n≈230) or chemotherapy (n≈115). Pts with platinum-resistant (progressive disease [PD] ≥1 to < 6 mo after last platinum) or partially platinum-sensitive disease (PD ≥ 6 to < 12 mo after last platinum) will receive rucaparib or weekly paclitaxel; pts with platinum-sensitive disease (PD ≥ 12 mo after last platinum) will receive rucaparib or platinum-based therapy (single-agent or doublet, per investigator discretion). Pts receiving chemotherapy have the option to cross over to rucaparib upon radiographic disease progression. The primary endpoint is investigator-assessed progression-free survival (RECIST version 1.1). Secondary endpoints include overall survival, objective response rate, RECIST/CA-125 response, duration of response, and patient-reported outcomes. Safety will be summarised descriptively using standard adverse event reporting.

Clinical trial identification

EudraCT 2016-000816-14; NCT02855944

Legal entity responsible for the study

Clovis Oncology, Inc.


Clovis Oncology, Inc.


R.S. Kristeleit: Consulting or advisory role: Clovis Oncology, Roche/Genentech, Sotio, Lytix Biopharma, Medivation Travel, Accommodations, Expenses: Clovis Oncology, Basilea Honoraria: Clovis Oncology, Roche/Genentech, AstraZeneca. D. Lorusso: Consulting or Advisory Role: AstraZeneca, Clovis Oncology, Roche, PharmaMar Travel, Accommodations, Expenses: Roche, PharmaMar. A. Oaknin: Consulting or Advisory Role: PharmaMar, Clovis Oncology, Roche, AstraZeneca. C. Tankersley, L. Maloney, S. Goble, A. Dowson, H. Giordano: Employment: Clovis Oncology Stock and Other Ownership Interests: Clovis Oncology. C. Unger: Employment: Clovis Oncology Stock and Other Ownership Interests: Clovis Oncology, Sillajen. A.M. Oza: Consulting or Advisory Role: Amgen, Verastem, Clovis Oncology, Immunovaccine Travel, Accommodations, Expenses: AstraZeneca Honoraria: WebRx. All other authors have declared no conflicts of interest.

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