Phase II Study of Everolimus in Children and Adolescents With Refractory or Relapsed Osteosarcoma
|ClinicalTrials.gov Identifier: NCT01216826|
Recruitment Status : Unknown
Verified August 2013 by Sidnei Epelman, Hospital Santa Marcelina.
Recruitment status was: Recruiting
First Posted : October 7, 2010
Last Update Posted : August 7, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Refractory or Relapsed Osteosarcoma||Drug: Everolimus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Everolimus in Children and Adolescents With Refractory or Relapsed Osteosarcoma|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||December 2014|
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.
- Determine the Everolimus aim response in children and adolescents with refractory or relapsed osteosarcoma [ Time Frame: Up to 2 years. ]
- Define Everolimus toxicity in this population [ Time Frame: Up to 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|