NCT01337401

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Institute of Cancer Research, United Kingdom · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alveolar Soft-part Sarcoma

Interventions

Type	Name	Description
DRUG	Cediranib	30mg once daily, oral until disease progression
DRUG	Placebo	30mg, once daily, oral until 24 weeks or disease progression if sooner

Timeline

• Start date: 2011-07-01
• Primary completion: 2019-07-01
• Completion: 2020-01-01
• First posted: 2011-04-18
• Last updated: 2019-01-24

Locations

11 sites across 3 countries: Australia, Spain, United Kingdom