Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000020886
Ethics application status
Approved
Date submitted
3/01/2012
Date registered
5/01/2012
Date last updated
9/09/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial of cediranib in the treatment of patients with alveolar soft part sarcoma
Scientific title
A phase II trial of cediranib in the treatment of patients with alveolar soft part sarcoma (CASPS)
Secondary ID [1] 279651 0
EudraCT 2010-021163-33
Secondary ID [2] 279652 0
NCT01337401 on ClinicalTrials.gov
Secondary ID [3] 279653 0
ISRCTN63733470
Universal Trial Number (UTN)
Trial acronym
CASPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alveolar soft part sarcoma 285458 0
Condition category
Condition code
Cancer 285642 285642 0 0
Sarcoma (also see 'Bone') - soft tissue

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cediranib; 30mg tablet once daily, orally; until disease progression
Intervention code [1] 283937 0
Treatment: Drugs
Comparator / control treatment
Placebo (lactose); 1 tablet once daily, orally; for 24 weeks or until disease progression (whichever occurs first)
Control group
Placebo

Outcomes
Primary outcome [1] 286198 0
Efficacy of cediranib in the treatment of ASPS by measuring the percentage change in the sum of target marker lesion diameters from randomisation to week 24 (or progression of sooner) compared to treatment with placebo.
Timepoint [1] 286198 0
24 weeks
Secondary outcome [1] 295366 0
Response rate at week 24, best response using RECISTv1.1 and best reduction (%) in tumour size
Timepoint [1] 295366 0
24 weeks
Secondary outcome [2] 295367 0
Progression-free survival and percentage alive and progression-free at 12 months
Timepoint [2] 295367 0
12 months
Secondary outcome [3] 295368 0
Overall survival
Timepoint [3] 295368 0
12 week intervals
Secondary outcome [4] 295369 0
Safety and tolerability profile of cediranib in patients with ASPS
Timepoint [4] 295369 0
Assessments at 8-12 week intervals

Eligibility
Key inclusion criteria
1. Histologically confirmed diagnosis of Alveolar Soft Part Sarcoma (ASPS)(central confirmation not required at study entry)
2. Age 16 years and older
3. Availability of archived tissue blocks to enable confirmation of t(X;17) translocation
4. ECOG Performance Status of 0-1
5. Life expectancy of >12 weeks
6. Progressive disease within 6 months prior to randomisation
7. Measurable metastatic disease using RECISTv1.1, i.e. at least one lesion 10mm in diameter (15mm in short axis for nodal lesions) assessable by spiral CT (or MRI for brain metastases)
8. Patients with brain metastases are permitted provided disease is controlled with a stable dose of coricosteroid and/or non-enzyme inducing anticonvulsent
9. The capacity to understand the patient information sheet and ability to provide written informed consent
10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
11. Able to swallow and retain oral medication
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count <=1.5 x 10^9/L or platelet count <=100 x 10^9/L
2. Serum bilirubin <=1.5 x ULN (unless Gilbert’s syndrome)
3. ALT or AST >= 2.5 x ULN. If liver metastases are present, ALT or AST > 5 x ULN
4. Serum creatinine > 1.5 x ULN or a creatinine clearance (calculated or measured) of <=50mL/min
5. Greater than +1 proteinuria unless urinary protein < 1.5g in a 24 hr period or protein/creatinine ratio < 1.5
6. History of significant gastrointestinal impairment, as judged by the Investigator, that would significantly affect the absorption of cediranib
7. Patients with a history of poorly controlled hypertension with resting blood pressure >150/100 mmHg in the presence or absence of a stable regimen of anti-hypertensive therapy
8. Any evidence of severe or uncontrolled co-morbidities e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease, or active and uncontrolled infection
9. Evidence of prolonged QTc >480 msec (using Bazetts correction, for which the formula is: QTc = QT/sqRR) or history of familial long QT syndrome
10. Significant recent haemorrhage (>30mL bleeding/ episode in previous 3 months) or haemoptysis (>5mL fresh blood in previous 4 weeks)
11. Major thoracic or abdominal surgery in the 14 days prior to entry into the study, or a surgical incision that is not fully healed
12. Pregnant or breast-feeding women; women of childbearing potential with a positive pregnancy test prior to receiving study medication; women the intention of pregnancy during study treatment; women of child bearing potential unwilling to have a urine or serum pregnancy test prior to study entry (even if surgically sterilised)
13. Men and women of childbearing potential unwilling to use adequate birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with
spermicide, implantable or injectable contraceptives or surgical sterilisation) for the duration of the study and should continue such precautions for 2 weeks after receiving
the last study treatment
14. History of anticancer (including investigational, non-registered) treatment in the four weeks prior to first dose of cediranib, with the exception of palliative radiotherapy for
symptom control
15. Known hypersensitivity to cediranib or any of its excipients
16. History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years, unless the patient has been disease free for 2 years and there is a tissue diagnosis of the primary cancer of interest from a target lesion
17. Other concomitant anti-cancer therapy (including LHRH agonists) except steroids
18. Recent history of thrombosis
19. Patients with brain metastases if they are symptomatic requiring increasing steroids in the previous six weeks to study entry or those with evidence of recent and/or active
bleeding, or those causing uncontrolled seizures

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)
The person who determines if a subject is eligible for inclusion in the trial is unaware (when this decision is made) to which group the subject will be allocated. Allocation is concealed by central randomisation by phone/fax/computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random allocation to treatment arm with 2:1 ratio cediranib:placebo
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Patients assigned to placebo will switch to cediranib after 24 weeks or disease progression (if sooner)
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2012
Actual
29/06/2012
Date of last participant enrolment
Anticipated
1/07/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 2301 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 2302 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 4843 0
2050
Recruitment postcode(s) [2] 4844 0
4102
Recruitment outside Australia
Country [1] 4032 0
United Kingdom
State/province [1] 4032 0
Country [2] 5974 0
Spain
State/province [2] 5974 0

Funding & Sponsors
Funding source category [1] 284435 0
Charities/Societies/Foundations
Name [1] 284435 0
Cancer Research UK
Country [1] 284435 0
United Kingdom
Funding source category [2] 284436 0
Commercial sector/Industry
Name [2] 284436 0
AstraZeneca
Country [2] 284436 0
United Kingdom
Primary sponsor type
Hospital
Name
The Institute of Cancer Research / Royal Marsden Hospital NHS Foundation Trust (UK)
Address
Glen House (F125), 2.1
125 Old Brompton Road
London SW7 3RP
Country
United Kingdom
Secondary sponsor category [1] 283359 0
Other Collaborative groups
Name [1] 283359 0
Australasian Sarcoma Study Group
Address [1] 283359 0
Level 2, Research Division
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002
Country [1] 283359 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286412 0
Sydney Local Health District
Ethics committee address [1] 286412 0
Ethics committee country [1] 286412 0
Australia
Date submitted for ethics approval [1] 286412 0
16/01/2012
Approval date [1] 286412 0
09/03/2012
Ethics approval number [1] 286412 0
Ethics committee name [2] 286413 0
Metro South Hospital and Health Service Human Research Ethics Committee
Ethics committee address [2] 286413 0
Ethics committee country [2] 286413 0
Australia
Date submitted for ethics approval [2] 286413 0
18/01/2012
Approval date [2] 286413 0
23/03/2012
Ethics approval number [2] 286413 0

Summary
Brief summary
This study is investigating whether the drug cediranib might be effective as a treatment for alveolar soft part sarcoma. It will test cediranib against placebo and measure the effects after 24 weeks.
Who is it for? You may be eligible for this study if you are aged 16 years and over, have a histologically confirmed diagnosis of alveolar soft part sarcoma and give your consent to take part. The full inclusion criteria details can be found in the relevant section of this form.
Trial details: In this study, you will receive either the drug cediranib or placebo in the form of one tablet once a day, taken orally over a total period of 24 weeks. If you are allocated to placebo, you will switch to cediranib after 24 weeks (or if your disease progresses before this time). If you are allocated to cediranib, you will continue on this treatment until such time as your disease progresses. You will be required to attend regular clinic visits for routine tests and assessments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33571 0
Prof Martin Tattersall
Address 33571 0
Chris O'Brien Lifehouse
119-143 Missenden Road
Camperdown NSW 2050
Country 33571 0
Australia
Phone 33571 0
+61 2 8514 0759
Fax 33571 0
Email 33571 0
[email protected]
Contact person for public queries
Name 16818 0
Ms Sharina Rosli
Address 16818 0
Centre for Biostatistics & Clinical Trials
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002
Country 16818 0
Australia
Phone 16818 0
+61 3 9656 5826
Fax 16818 0
+61 3 9656 1420
Email 16818 0
[email protected]
Contact person for scientific queries
Name 7746 0
Ms Sharina Rosli
Address 7746 0
Centre for Biostatistics & Clinical Trials
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002
Country 7746 0
Australia
Phone 7746 0
+61 3 9656 5826
Fax 7746 0
+61 3 9656 1420
Email 7746 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.