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ICON 9-an international phase III randomized study to evaluate the efficacy of maintenance therapy with olaparib and cediranib or olaparib alone in patients with relapsed platinum-sensitive ovarian cancer following a response to platinum-based chemotherapy
Elyashiv, O. Ledermann, J. Parmar, G. Farrelly, L. Counsell, N. Feeney, A. El-Khouly, F. Macdonald, I. Neto, A. Arthur-Darkwa, E.
Elyashiv, O.
Ledermann, J.
Parmar, G.
Farrelly, L.
Counsell, N.
Feeney, A.
El-Khouly, F.
Macdonald, I.
Neto, A.
Arthur-Darkwa, E.
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Abstract
Background: Two novel biological agents-cediranib targeting angiogenesis, and olaparib targeting DNA repair processes-have individually led to an improvement in ovarian cancer control. The aim of ICON9 is to investigate the combination of cediranib and olaparib maintenance in recurrent ovarian cancer following platinum-based therapy.
Primary objective: To assess the efficacy of maintenance treatment with olaparib in combination with cediranib compared with olaparib alone following a response to platinum-based chemotherapy in women with platinum-sensitive ovarian, fallopian tube or peritoneal cancer during first relapse.
Study hypothesis: Maintenance therapy with cediranib and olaparib in combination is associated with improved patient outcomes compared with olaparib alone.
Trial design: International phase III randomized controlled trial. Following a response to platinum-based chemotherapy patients are randomized 1:1 to either oral olaparib and cediranib (intervention arm) or oral olaparib alone (control arm).
Major inclusion criteria: Patients with a known diagnosis of high grade serous or endometrioid carcinoma of the ovary, fallopian tube or peritoneum, progressing more than 6 months after first-line platinum-based chemotherapy, who have responded to second-line platinum-based chemotherapy.
Primary endpoints: Progression-free and overall survival. Co-primary endpoints to be assessed using a fixed-sequence gatekeeping approach: (1) progression-free survival, all patients; (2) progression-free survival, BRCA wild type; (3) overall survival, all patients; (4) overall survival, BRCA wild type.
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Date
2020
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Elyashiv O, Ledermann J, Parmar G, Farrelly L, Counsell N, Feeney A, et al. ICON 9-an international phase III randomized study to evaluate the efficacy of maintenance therapy with olaparib and cediranib or olaparib alone in patients with relapsed platinum-sensitive ovarian cancer following a response to platinum-based chemotherapy. Int J Gynecol Cancer. 2020.