Alveolar Soft-part Sarcoma Clinical Trial
Official title:
A Phase II Trial of Cediranib in the Treatment of Patients With Alveolar Soft Part Sarcoma (CASPS)
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.
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. ;