Spots Global Cancer Trial Database for A Trial of Cediranib in the Treatment of Patients With Alveolar Soft Part Sarcoma (CASPS)

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Trial Identification

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

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

Study ID: NCT01337401

Conditions

Alveolar Soft-part Sarcoma

Interventions

Cediranib

Placebo

Study Description

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.

Detailed Description: 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.