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).

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000160033

Acronym

ICON6

Enrollment

500

Registered

2010-02-18

Start date

2011-01-01

Completion date

Unknown

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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

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 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).

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Histologically proven diagnosis of epithelial ovarian carcinoma, fallopian tube carcinoma or primary serous peritoneal carcinoma requiring treatment with further platinum-based chemotherapy > 6 months after their last cycle of first-line chemotherapy and 6 weeks after maintenance that is not chemotherapy based (computed tomographic scan [CT] or Magnetic Resonance Imaging [MRI] proven relapsed disease (measurable or non-measurable). Adequate bone marrow function. Adequate liver function (within 14 days before randomisation). Adequate renal function.

Exclusion criteria

Non-epithelial ovarian cancer, including malignant mixed Mullerian tumours and mucinous carcinoma of the peritoneum. Poorly controlled hypertension (persistently elevated > 150/100mmHg, either systolic or diastolic or both, despite anti-hypertensive medication). History of inflammatory bowel disease (Crohn’s Disease or Ulcerative Colitis). Arterial thrombotic event (including transient ischaemic attack [TIA], cerebrovascular accident [CVA] and peripheral arterial embolus) within the previous 12 months. Significant haemorrhage of > 30ml in a single episode within 3 months or any haemoptysis. Evidence of severe or uncontrolled cardiac disease. Prolonged QTc (corrected) interval of > 470msec on electrocardiogram [ECG], or a family history of long QT syndrome. History or clinical suspicion of brain metastases or spinal cord compression.

Outcome results