This website is designed to provide information about the ICON6 trial.
ICON6 is a randomised three-arm, three stage, double-blind, placebo-controlled multi-centre Gynaecologic Cancer InterGroup (GCIG) phase III trial.
ICON6 is designed to evaluate the safety and efficacy of platinum-based chemotherapy in combination with cediranib in women with platinum-sensitive relapsed ovarian cancer . Cediranib is an oral targeted small molecule inhibitor of a key signalling molecule Vascular Endothelial Growth Factor (VEGF) which is an oral inhibitor of tyrosine kinase (TK) activity and acts through blockade of the TK receptor. Cediranib (AZD2171) will be administered during platinum-based chemotherapy only (concurrent cediranib), or given during chemotherapy and continued as single agent maintenance therapy (concurrent and maintenance cediranib).
Accrual
The ICON6 trial closed to recruitment in December 2011.
Total number of patients recruited:
Statement on the Zemfirza (cediranib) marketing authorisation application withdrawal
On 19 September 2016, AstraZeneca officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zemfirza (the trade name of cediranib), for the treatment of ovarian cancer. The European Medicines Agency has now posted questions and answers about this on their website.
The ICON6 trial conducted by the Medical Research Council (MRC) Clinical Trials Unit at UCL was a high quality international trial that found that cediranib increased progression-free survival by 2.5 months in patients with platinum sensitive relapsed ovarian cancer.
The ICON6 trial was conducted to a high standard. It was not designed as a licensing trial, so was conducted in line with the principles of GCP, rather than full ICH-GCP processes. Sensitivity analyses assessing the impact of the issues identified in the inspection showed they made only a minor and inconsequential difference to the results. We are confident that the ICON6 results are reliable: cediranib improves PFS for women with platinum sensitive relapsed ovarian cancer.
One of the MRC Clinical Trials Unit’s main aims is to deliver swifter and more effective translation of scientific research into patient benefits. It is very disappointing that there will now be a delay in bringing the benefits of cediranib to a group of patients who have limited treatment options
The ICON6 trial conducted by the Medical Research Council (MRC) Clinical Trials Unit at UCL was a high quality international trial that found that cediranib increased progression-free survival by 2.5 months in patients with platinum sensitive relapsed ovarian cancer.
“One of the Clinical Trial Unit’s main aims is to deliver swifter and more effective translation of scientific research into patient benefits. It is very disappointing that there will now be a delay in bringing the benefits of Cediranib to a group of patients who have limited treatment options".
The Lancet has recently published an update to the progression-free survival (PFS) data first presented at the European Society of Medical Oncology congress (ESMO) 2013. These results show that there is a benefit to be derived from the use of cediranib (AZD171) when given concurrently with chemotherapy and continued as maintenance for patients with platinum sensitive ovarian cancer when compared to standard chemotherapy only. The secondary endpoint of overall survival will require more follow up before analysis.
In July 2015, Cediranib (AZD171) was submitted by AstraZeneca for marketing authorisation from the European Medicines Agency. A decision is expected in 2016.
We would like to take this opportunity to thank all patients and their families for their contribution, and all trial personnel for their support.
Final Progression Free Survival analysis presented at The European Cancer Congress (ECCO 17 - ESMO 38 - ESTRO 32) 2013
The ICON6 Chief Investigator Professor Jonathan Ledermann presented the results of the final Progression Free Survival analysis at The European Cancer Congress in Amsterdam on 30th September 2013. The full abstract is available at the link below, just enter "ICON6" into the field labelled 'Abstract Title' and then click the 'Search' button to find the abstract.
ICON6 Abstract for The European Cancer Congress 2013
ICON6 was selected for inclusion in The European Cancer Congress media programme. The full press release is available at the link below:
ICON6 Press Release for The European Cancer Congress 2013
A video of the ICON6 Chief Investigator Professor Jonathan Ledermann presenting the Progression Free Survival results of the ICON6 trial to the media is also available at the link below:
Video of ICON6 Presentation to the media at The European Cancer Congress 2013