Phase II Open Label, Non-randomized Study of Sorafenib and Everolimus in Relapsed and Non-resectable Osteosarcoma

PHASE2CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
Metastatic OsteosarcomaRelapsed Osteosarcoma
Interventions
DRUG

Sorafenib

Sorafenib tablet 200 milligrams packed in bottle containing 140 tablets. Sorafenib will be administered orally twice daily at the same time every day. Two 200 mg tablets will be taken either one hour before or two hours after a meal followed by a glass of water in the morning and in the evening. In general, patient should have a low to moderate fat meal. Patients will receive Sorafenib until progression, toxicity, withdrawal of informed consent or clinical investigator decision

DRUG

Everolimus

Everolimus is formulated in tablets of 2.5 or 5 mg strength, blister-packed under aluminum foil in units of 10 tablets. Everolimus will be administered orally once daily at the same time every day immediately after a meal, as a single dose of 5 mg. Patients should have a low-fat breakfast. After this light meal, study medication of Everolimus is to be taken. The tablets of Everolimus should not be chewed or crushed. Patients will receive Everolimus until progression, toxicity, withdrawal of informed consent or clinical investigator decision

Trial Locations (1)

10060

Fondazione del Piemonte per l'Oncologia IRCC Candiolo, Candiolo

All Listed Sponsors
lead

Italian Sarcoma Group

NETWORK

NCT01804374 - Phase II Open Label, Non-randomized Study of Sorafenib and Everolimus in Relapsed and Non-resectable Osteosarcoma | Biotech Hunter | Biotech Hunter