Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01337401




Registration number
NCT01337401
Ethics application status
Date submitted
11/04/2011
Date registered
18/04/2011
Date last updated
24/01/2019

Titles & IDs
Public title
A Trial of Cediranib in the Treatment of Patients With Alveolar Soft Part Sarcoma (CASPS)
Scientific title
A Phase II Trial of Cediranib in the Treatment of Patients With Alveolar Soft Part Sarcoma (CASPS)
Secondary ID [1] 0 0
2010-021163-33
Secondary ID [2] 0 0
ICR-CTSU/2010/10027
Universal Trial Number (UTN)
Trial acronym
CASPS
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cediranib
Treatment: Drugs - Placebo

Experimental: Blinded Cediranib -

Placebo Comparator: Blinded Placebo -


Treatment: Drugs: Cediranib
30mg once daily, oral until disease progression

Treatment: Drugs: Placebo
30mg, once daily, oral until 24 weeks or disease progression if sooner
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the 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 if sooner) compared to treatment with placebo.
Timepoint [1] 0 0
24 Weeks of treatment
Secondary outcome [1] 0 0
Response rate at week 24, best response using RECISTv1.1 and best reduction (%) in tumour size
Timepoint [1] 0 0
24 Weeks of treatment
Secondary outcome [2] 0 0
Progression-free survival and percentage alive and progression-free at 12 months (APF12)
Timepoint [2] 0 0
12 months of treatment
Secondary outcome [3] 0 0
Length of Overall survival
Timepoint [3] 0 0
Patients will be followed up every 12 weeks
Secondary outcome [4] 0 0
The safety and tolerability profile of cediranib in patients with ASPS
Timepoint [4] 0 0
Assessments will be made at every study visit (8-12 weekly)

Eligibility
Key inclusion criteria
1. Histologically confirmed diagnosis of ASPS (central confirmation not required at study
entry)

2. Age 16 years and older

3. Availability of archived tissue blocks or unstained slides to enable confirmation of
t(X;17) translocation

4. ECOG Performance Status of 0-1

5. Life expectancy of >12 weeks

6. Progressive disease as defined by RECIST v1.1 within 6 months prior to randomisation

7. Measurable metastatic disease using RECISTv1.1, i.e. at least one lesion 10 mm in
diameter (15 mm in short axis for nodal lesions) assessable by CT (or MRI for brain
metastases).

8. Patients with brain metastases are permitted provided disease is controlled with a
stable dose of corticosteroid and/or non-enzyme inducing anticonvulsant

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
109/L or platelet count =100 x 109/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/vRR) 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. Previous treatment with cediranib.

16. Known hypersensitivity to any excipient of cediranib.

17. 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.

18. Other concomitant anti-cancer therapy (including LHRH agonists) except steroids

19. Recent history of thrombosis

20. 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2020
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Spain
State/province [1] 0 0
Barcelona
Country [2] 0 0
Spain
State/province [2] 0 0
Madrid
Country [3] 0 0
Spain
State/province [3] 0 0
Zaragoza
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Bristol
Country [5] 0 0
United Kingdom
State/province [5] 0 0
London
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Manchester
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Newcastle-Upon-Tyne
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Other
Name
Institute of Cancer Research, United Kingdom
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Marsden NHS Foundation Trust
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The study is a two-arm, randomised, double-blind, international, multi-centre phase II trial
of cediranib in Alveolar Soft Part Sarcoma (ASPS).

The study aims to confirm the ability of cediranib to halt disease progression in patients
with metastatic ASPS, as measured by the change in tumour size at 24 weeks after
randomisation, and to produce objective response according to RECIST criteria.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01337401
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01337401