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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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).
Secondary ID [1] 786 0
EUDRACT: 2007-001346-41
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Platinum sensitive relapsed ovarian cancer 4221 0
Condition category
Condition code
Cancer 256989 256989 0 0
Ovarian and primary peritoneal

Study type
Description of intervention(s) / exposure
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).
Intervention code [1] 4282 0
Treatment: Drugs
Comparator / control treatment
All patients, regardless of the arm they are randomised to, will be planned to receive 6
cycles of platinum-based chemotherapy. ICON6 patients are treated with carboplatin AUC6 over 30-60 minutes, in combination with paclitaxel 175 mg/m2 over three hours, three weekly for six cycles, assuming that the patient is fit enough to receive this. Those not be fit enough to receive combination therapy due to additional toxicity, or those patients who decline combination therapy will be eligible to receive six cycles of single agent carboplatin. This is considered 'standard therapy' in this group of women.
Control group

Primary outcome [1] 5321 0
Stage 2 primary outcome; progression free survivial (PFS).
If a minimal level of activity of cediranib based on PFS and overal survival (OS) is not detected, the trial could be stopped early. Analysis will be performed when both at least 50 deaths and at least 90 progressions or deaths have occurred in the reference arn (Arm A) which is anticipated after 150 patients are randomised to Arm A and 450 patients total randomised to Arms B and C.
Timepoint [1] 5321 0
Stage 2; 2 years after stage 1
Secondary outcome [1] 8950 0
Stage 3- progression free survival, toxicity and Quality of Life.
To evaluate the nature, severity and frequentcy of toxicities.
Quality of life will be assessed by patient self reported questionnaires administered during treament and three monthly until progression.
Timepoint [1] 8950 0
Stage 3; 6 years
Secondary outcome [2] 241557 0
Stage 2- overall survival and toxicity.
Determined by seeing whether a minimal level of activity of cediranib can be detected by comparing OS in patients receiving chemotherapy alone (Arm A) with PFS in patients receiving chemotherapy and cediranib (arm B plus C).
Timepoint [2] 241557 0
Stage 2; 2 years after stage 1

Key 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.
Minimum age
18 Years
Maximum age
No limit
Can healthy volunteers participate?
Key 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
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.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed because central randomisation is by phone /fax /computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
After stage 1 (safety): if there are more than 15% of patients with grade 3 or 4 adverse events the study could be stopped or modified.
Stage 2 (activity). If a minimal level of activity of cediranib was not detected after 600 patients wererandomised, the trial could be stopped early.
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Active, not recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1398 0
Recruitment postcode(s) [2] 1399 0
Recruitment postcode(s) [3] 1400 0
Recruitment outside Australia
Country [1] 1543 0
New Zealand
State/province [1] 1543 0
North and South Island

Funding & Sponsors
Funding source category [1] 4403 0
Other Collaborative groups
Name [1] 4403 0
Medical Research Council Clinical Trial Unit
Address [1] 4403 0
222 Euston Road
London NW1 2DA
Country [1] 4403 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
5 Alma Rd
North Ryde 2113
Secondary sponsor category [1] 3962 0
Name [1] 3962 0
Address [1] 3962 0
Country [1] 3962 0

Ethics approval
Ethics application status
Ethics committee name [1] 6451 0
Cancer Institute of NSW
Ethics committee address [1] 6451 0
Cancer Institute NSW
Australian Technology Park
Biomedical Building
Suite 101, 1 Central Avenue
Ethics committee country [1] 6451 0
Date submitted for ethics approval [1] 6451 0
Approval date [1] 6451 0
Ethics approval number [1] 6451 0

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
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 29206 0
Address 29206 0
Country 29206 0
Phone 29206 0
Fax 29206 0
Email 29206 0
Contact person for public queries
Name 12453 0
Kerri Carlton
Address 12453 0
National Health and Medical Research Council (NHMRC )Clinical Trial Centre
Level 2
6-10 Mallett St
Camperdown 2050
Country 12453 0
Phone 12453 0
+61 2 9562 5067
Fax 12453 0
+61 2 9562 5094
Email 12453 0
Contact person for scientific queries
Name 3381 0
Julie Martyn
Address 3381 0
NHMRC Clinical Trial Centre
Level 2
6-10 Mallett St
Camperdown 2050
Country 3381 0
Phone 3381 0
+61 2 9562 5092
Fax 3381 0
+61 2 9562 5094
Email 3381 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary