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.
Adult
Clinical Trials, Phase III as Topic
Drug Resistance, Neoplasm
Female
Humans
Middle Aged
Neoplasm Recurrence, Local
/ drug therapy
Ovarian Neoplasms
/ drug therapy
Phthalazines
/ administration & dosage
Piperazines
/ administration & dosage
Poly(ADP-ribose) Polymerase Inhibitors
/ administration & dosage
Quinazolines
/ administration & dosage
Randomized Controlled Trials as Topic
Survival Analysis
fallopian tube neoplasms
medical oncology
ovarian cancer
peritoneal neoplasms
Journal
International journal of gynecological cancer : official journal of the International Gynecological Cancer Society
ISSN: 1525-1438
Titre abrégé: Int J Gynecol Cancer
Pays: England
ID NLM: 9111626
Informations de publication
Date de publication:
01 2021
01 2021
Historique:
accepted:
06
10
2020
pubmed:
25
10
2020
medline:
17
12
2021
entrez:
24
10
2020
Statut:
ppublish
Résumé
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. 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. Maintenance therapy with cediranib and olaparib in combination is associated with improved patient outcomes compared with olaparib alone. 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). 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. 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. 618 patients will be recruited. Accrual is expected to be completed in 2024 with presentation of results in 2025. ClinicalTrials.gov: NCT03278717.
Sections du résumé
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.
SAMPLE SIZE
618 patients will be recruited.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS
Accrual is expected to be completed in 2024 with presentation of results in 2025.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT03278717.
Identifiants
pubmed: 33097567
pii: ijgc-2020-002073
doi: 10.1136/ijgc-2020-002073
doi:
Substances chimiques
Phthalazines
0
Piperazines
0
Poly(ADP-ribose) Polymerase Inhibitors
0
Quinazolines
0
cediranib
NQU9IPY4K9
olaparib
WOH1JD9AR8
Banques de données
ClinicalTrials.gov
['NCT03278717']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
134-138Subventions
Organisme : Chief Scientist Office
ID : SCD/11
Pays : United Kingdom
Organisme : Cancer Research UK
ID : A19714 CRUK/15/074
Pays : United Kingdom
Informations de copyright
© IGCS and ESGO 2021. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.