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


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.

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.

Primary Outcome Measures:
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. [ Time Frame: 24 Weeks of treatment ]
Secondary Outcome Measures:
Response rate at week 24, best response using RECISTv1.1 and best reduction (%) in tumour size [ Time Frame: 24 Weeks of treatment ]
Progression-free survival and percentage alive and progression-free at 12 months (APF12) [ Time Frame: 12 months of treatment ]
Length of Overall survival [ Time Frame: Patients will be followed up every 12 weeks ]
The safety and