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Phase II Study of Everolimus in Children and Adolescents With Refractory or Relapsed Osteosarcoma

NCT01216826 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-08-07

No results posted yet for this study

Summary

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.

Conditions

  • Refractory or Relapsed Osteosarcoma

Interventions

DRUG

Everolimus

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.

Sponsors & Collaborators

  • Sidnei Epelman

    lead OTHER

Principal Investigators

  • Sidnei Epelman, MD · Hospital Santa Marcelina

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2014-06-30
Completion
2014-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01216826 on ClinicalTrials.gov