A Phase II, Open Label, Non-randomized Study of Second or Third Line Treatment With the Combination of Sorafenib and Everolimus in Patients Affected by Relapsed and Non-resectable High-grade Osteosarcoma
Patients affected by metastatic or relapsed osteosarcoma which progressed after first or
further line treatments still have a poor outcome. Standard chemotherapy has limited
activity in these patients.
In a previous study in patient affected by relapsed unresectable osteosarcoma, sorafenib
alone demonstrated promising activity. In the preclinical setting, everolimus was able to
improve the activity of sorafenib. Sorafenib and everolimus, by hitting crucial pathways
which are essential for osteosarcoma cell proliferation and survival, with an entirely
different approach aimed to overcome the resistance to standard chemotherapy showed by
relapsed osteosarcoma. In this trial, all patients will be treated with sorafenib and
everolimus at the dosage of 800 mg and 5 mg per day, respectively. Both drugs have to be
taken orally. The treatment will be continued until progression or unacceptable toxicities.
The objective of the present trial is to obtain a 50% rate of patients alive and free from
progression of their disease 6 months after trial enrolment. The disease will be evaluated
every 2 months with a CT scan.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival rate at 6 months
Progression Free Survival rate at 6 months refers to the rate of patients alive and free from progression of the disease at 6 months from registration into the study. Disease will be assessed every 8 weeks up to 2 years until progression or death whichever came first.
6 months from registration into the study
No
Massimo Aglietta, MD
Principal Investigator
IRCC Candiolo
Italy: Ministry of Health
SERIO
NCT01804374
June 2011
September 2013
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