ActivePhase 3ACTRN12610000160033

A randomised, placebo-controlled, trial of concurrent cediranib [AZD2171] (with platinum-based chemotherapy) and concurrent and maintenance cediranib in women with platinum-sensitive relapsed ovarian cancer.

ICON6 is a randomised three-arm, three stage, double-blind, placebo-controlled multicentre Gynaecologic Cancer InterGroup (GCIG) phase III trial, designed to evaluate the safety and efficacy of platinum-based chemotherapy in combination with cediranib in women with platinum-sensitive relapsed ovarian cancer. Cediranib (AZD2171) will be administered during platinum-based chemotherapy only (concurrent cediranib), or given during chemotherapy and continued as single agent (maintenance therapy) for up to 18 months(concurrent and maintenance cediranib).


Sponsor

AstraZenica

Enrollment

500 participants

Start Date

Jan 1, 2011

Study Type

Interventional

Conditions

Summary

The purpose of this study is to investigate whether the benefits of chemotherapy can be improved in women with relapsed ovarian cancer, by adding a new drug called Cediranib. Chemotherapy describes drug treatments which kill or control the growth of cancer cells. Cediranib is a ‘targeted therapy’ rather than a chemotherapy drug. As cancers grow they need to develop their own new blood supply to survive and this development of new blood supply vessels is known as angiogenesis. Cediranib works by slowing or stopping the growth of these new blood vessels which will hopefully interfere with the tumour’s ability to grow and spread to other parts of the body. It may also make the planned chemotherapy more effective. We believe that this may be an important new way to treat cancer. Although there are good scientific reasons from laboratory studies why Cediranib should work on ovarian cancer cells, it has not yet been tested in a large number of women with ovarian cancer. Cediranib is an investigational medical product which is not licensed for use in treatment of ovarian cancer or any other cancer


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether adding the drug cediranib to standard platinum-based chemotherapy improves outcomes for women with ovarian, fallopian tube, or peritoneal cancer that has come back more than 6 months after first treatment. It is for women aged 18 and older whose cancer responded to their initial platinum chemotherapy.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Cediranib is an oral targeted small molecule inhibitor of a key signalling molecule and acts through blockade of a key receptor. Cediranib will be administered as a daily 20mg tablet (ie oral) during

Cediranib is an oral targeted small molecule inhibitor of a key signalling molecule and acts through blockade of a key receptor. Cediranib will be administered as a daily 20mg tablet (ie oral) during platinum-based chemotherapy only (concurrent cediranib), OR given as an oral 20mg tablet during chemotherapy and continued daily as single agent maintenance therapy for up to 18 months (concurrent and maintenance cediranib).


Locations(1)

North and South Island, New Zealand

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ACTRN12610000160033