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
Authors
Elyashiv, O.Ledermann, J.
Parmar, G.
Farrelly, L.
Counsell, N.
Feeney, A.
El-Khouly, F.
Macdonald, I.
Neto, A.
Arthur-Darkwa, E.
Burnett, E.
Jayson, Gordon C
Mileshkin, L.
Gourley, C.
Nicum, S.
Affiliation
University College CRUK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UKIssue Date
2020
Metadata
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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.Citation
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.Journal
International Journal of Gynecological CancerDOI
10.1136/ijgc-2020-002073PubMed ID
33097567Additional Links
https://dx.doi.org/10.1136/ijgc-2020-002073Type
ArticleLanguage
enae974a485f413a2113503eed53cd6c53
10.1136/ijgc-2020-002073
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