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

Phase 2
16 Years
Open (Enrolling)
Alveolar Soft-part Sarcoma

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Trial Information

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

Patients aged 16 years and older with a histologically confirmed diagnosis of ASPS will be
recruited. Eligible patients will be randomised to receive cediranib (30 mg daily po) or
placebo (30 mg daily po) in a 2:1 ratio. At 24 weeks post randomisation, treatment will be
unblinded after which time all patients on placebo and those who have not progressed on
active treatment will be given cediranib. Treatment will then continue until objective
disease progression or death.

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 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 spiral 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

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 ≤

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

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/√RR) 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

24 Weeks of treatment

Safety Issue:



United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

May 2011

Completion Date:

December 2017

Related Keywords:

  • Alveolar Soft-part Sarcoma
  • Cediranib
  • ASPS
  • Sarcoma
  • Sarcoma, Alveolar Soft Part
  • Sarcoma