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A Phase II Multicenter Trial of RAD001 in Patients With Metastatic or Recurrent Sarcomas

Phase 2
17 Years
Not Enrolling
Soft Tissue Sarcomas, Bone Sarcomas

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Trial Information

A Phase II Multicenter Trial of RAD001 in Patients With Metastatic or Recurrent Sarcomas

This multicenter, phase II trial evaluated the efficacy and safety of everolimus in patients
with metastatic or recurrent bone and soft tissue sarcoma after failure of anthracycline
and/or ifosfamide.

Inclusion Criteria:

- Patients with histologically confirmed metastatic, unresectable bone or soft tissue
sarcomas who had past treatment with anthracycline and/or ifosfamide to which the
disease was primarily refractory or progressed after initial response.

- Any of above drugs is allowed to be used as adjuvant treatment.

- Unidimensionally measurable disease

- 3 or less than prior chemotherapies

- Age 17 years old or older

- ECOG performance status 2 or less, Life expectancy 6 month or less

- Adequate bone marrow, liver, kidney, and cardiac function

- Written informed consent

Exclusion Criteria:

- Pregnant or lactating patients

- Patients with resectable metastasis

- Patients with history of CNS metastasis

- Gastrointestinal stromal tumors, chondrosarcoma, neuroblastoma

- Hypersensitivity to the active substance, to other rapamycin derivatives, or to any
of the excipients.

- Any preexisting medical condition of sufficient severity to prevent full compliance
with the study

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival rate at 16 weeks

Outcome Description:

Determined as the proportion of progression-free (complete response, partial response and stable disease) at 16 weeks of treatment

Outcome Time Frame:

16 weeks

Safety Issue:


Principal Investigator

Jin-Hee Ahn, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center


Korea: Food and Drug Administration

Study ID:




Start Date:

April 2010

Completion Date:

Related Keywords:

  • Soft Tissue Sarcomas
  • Bone Sarcomas
  • Soft tissue sarcomas
  • Bone sarcomas
  • RAD001
  • Refractory to conventional chemotherapy
  • Osteosarcoma
  • Sarcoma