CASPS: A Phase II trial of Cediranib in ASPS patients

CASPS is a two-arm, randomised, double-blind, placebo-controlled, Phase II trial of cediranib in ASPS patients. The primary objective is to evaluate the efficacy of cediranib by measuring the percentage change in the sum of target marker lesion diameters from randomisation to week 24 compared to placebo. Secondary objectives include: progression-free survival, overall survival and safety and tolerability of cediranib in ASPS patients. Tissue markers of tumour response, circulating markers of angiogenesis, and changes in circulating endothelial cells/precursor cells in response to cediranib will be explored. Thirty six patients with progressive, metastatic, histologically confirmed ASPS will be recruited. Patients will be randomised to 24 weeks of blinded cediranib or placebo, after which treatment will be unblinded and all patients offered open-label cediranib until objective disease progression, or death if sooner.