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Trial from ANZCTR

A phase II trial of cediranib in the treatment of patients with alveolar soft part sarcoma (CASPS)

  • Recruiting
    Recruitment status at the time of last update
  • Ethics status: Approved
    What is the status of the ethics application?
  • Prospectively registered
    Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
  • Up to date
    Has the trial been updated in the last 12 months?
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12612000020886

Health condition

Alveolar soft part sarcoma

Recruitment countries

Australia, United Kingdom, Spain

Recruitment site location(s) (State)

New South Wales, Queensland

Recruitment status

Recruiting

Anticipated date of first participant enrolment

01 July 2012

Ethics application status

Approved

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.

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

0 No limit

Gender

Both males and females

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

Contact details and further information

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

Contact person for information and recruitment

Ms Sharina Rosli
Centre for Biostatistics & Clinical Trials
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002
Australia
+61 3 9656 5826
Sharina.Rosli@petermac.org



Trial from ClinicalTrials.gov

A Trial of Cediranib in the Treatment of Patients With Alveolar Soft Part Sarcoma (CASPS)

  • Recruiting
    Recruitment status at the time of last update
  • Prospectively registered
    Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
  • Up to date
    Has the trial been updated in the last 24 months?
Key trial Information

Trial ID

NCT01337401

Recruitment status

Recruiting

Anticipated date of first participant enrolment

01 May 2011

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.

Eligibility

Key inclusion criteria

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

Gender

Both

Key exclusion criteria

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.