Phase II Study of Everolimus in Children and Adolescents With Refractory or Relapsed Osteosarcoma
The purpose of this study is to determine the Everolimus aim response in children and adolescents with refractory or relapsed osteosarcoma.
The aim response is defined as complete or partial response (according to RECIST criteria) for at least 4 weeks, or stable disease for at least 12 weeks.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Everolimus in Children and Adolescents With Refractory or Relapsed Osteosarcoma|
- Determine the Everolimus aim response in children and adolescents with refractory or relapsed osteosarcoma [ Time Frame: Up to 2 years. ] [ Designated as safety issue: No ]
- Define Everolimus toxicity in this population [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Everolimus will be administered every day, initial dose 5 mg/m²/dia, in 28 days cycles. Maximum dosis: 10 mg/day. The cycles will be repeated till progression disease or untolerable toxicity.
Other Name: Afinitor, RAD.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01216826
|Hospital Santa Marcelina||Recruiting|
|Sao Paulo, SP, Brazil, 08270070|
|Contact: Sidnei Epelman, MD +55 11 2522-2472 email@example.com|
|Principal Investigator:||Sidnei Epelman, MD||Hospital Santa Marcelina|