Status:
COMPLETED
RAD001 in Advanced Sarcoma
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Novartis
Conditions:
Soft Tissue Sarcomas
Bone Sarcomas
Eligibility:
All Genders
17+ years
Phase:
PHASE2
Brief Summary
This trial intends to test the efficacy and safety of RAD001 in patients with advanced sarcoma who failed to conventional chemotherapy.
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01830153
Start Date
April 1 2010
Last Update
April 12 2013
Active Locations (8)
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1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 463-707
2
Asan Medical Center, University of Ulsan College of Medicine
Seoul, N/A = Not Applicable, South Korea, 138-736
3
Yeongnam University College of Medicine
Daegu, South Korea
4
Chungnam National University Hospital
Daejeon, South Korea, 301-721