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Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
15/06/2018
Funder:
CRUK & AstraZeneca
Sponsor:
UCL
Chief Investigator:
Shibani Nicum
Recruitment target:
618
EudraCT number:
2017-000161-75
Contact details:
ctc.icon9@ucl.ac.uk
Lay summary:
ICON9
An international phase III randomised 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
Description
Design: ICON9 is an international phase III randomised study to evaluate the efficacy of maintenance olaparib and cediranib combination therapy or olaparib alone in patients with relapsed platinum-sensitive ovarian cancer following a response to platinum-based chemotherapy.  
Treatment:
Women whose disease responds to platinum-based chemotherapy following 3 to 4 cycles can be registered for HRD testing of archival tumour specimens. Following a response (partial/complete response) to platinum-based chemotherapy (4-6 cycles) for first recurrence of platinum sensitive relapsed ovarian/fallopian tube/primary peritoneal cancer, patients will be randomised to receive one of the following two arms:

Arm 1 – Oral olaparib 300mg twice daily and cediranib 20mg once daily. 

Arm 2 - Oral olaparib 300mg twice daily. 

The regimen may be continued beyond progression until trial closure if the patient is deemed to still be deriving clinical benefit.

Key inclusion/exclusion criteria: Patients must have a histologically proven diagnosis of high grade serous or endometrioid carcinoma of the ovary, fallopian tube or peritoneum, progressing more than 6 months after day 1 of the last cycle of first-line platinum-based chemotherapy and requiring treatment with second-line platinum-based chemotherapy. All patients must have completed a minimum of 4 cycles of platinum-based chemotherapy for first relapse (2nd line treatment) with at least a partial response on imaging (CT or MRI) by RECIST 1.1 if measureable disease or CA125 response by GCIG criteria if non-measurable disease. 

Patients with non-epithelial ovarian cancer, carcinosarcoma and mucinous carcinomas or ovarian clear-cell carcinoma and evidence of severe or uncontrolled cardiac disease are not eligible.
Duration of recruitment: Anticipated 3 years recruitment and 3 years follow up. 
Aim
ICON9 will assess the efficacy, safety and tolerability of maintenance olaparib in combination with cediranib compared to maintenance olaparib alone following a response to platinum-based chemotherapy in women with relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer. Prognostic and predictive factors will be studied from tumour and blood samples. 
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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