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Trial registered on ANZCTR


Registration number
ACTRN12610000160033
Ethics application status
Approved
Date submitted
22/01/2009
Date registered
18/02/2010
Date last updated
23/05/2012
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
ICON6
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

Intervention/exposure
Study type
Interventional
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
Historical

Outcomes
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

Eligibility
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
Sex
Females
Can healthy volunteers participate?
No
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
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.

Study design
Purpose of the study
Treatment
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
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,QLD,WA,TAS
Recruitment postcode(s) [1] 1398 0
2000
Recruitment postcode(s) [2] 1399 0
3000
Recruitment postcode(s) [3] 1400 0
4000
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
Country [1] 4403 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
AstraZenica
Address
5 Alma Rd
North Ryde 2113
Country
Australia
Secondary sponsor category [1] 3962 0
None
Name [1] 3962 0
Address [1] 3962 0
Country [1] 3962 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6451 0
Cancer Institute of NSW
Ethics committee address [1] 6451 0
Ethics committee country [1] 6451 0
Australia
Date submitted for ethics approval [1] 6451 0
31/03/2009
Approval date [1] 6451 0
Ethics approval number [1] 6451 0
2009C/03/087

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
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
Australia
Phone 12453 0
+61 2 9562 5067
Fax 12453 0
+61 2 9562 5094
Email 12453 0
kerri.carlton@ctc.usyd.edu.au
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
Australia
Phone 3381 0
+61 2 9562 5092
Fax 3381 0
+61 2 9562 5094
Email 3381 0
julie.martyn@ctc.usyd.edu.au

No information has been provided regarding IPD availability


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No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
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Documents added automatically
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