RAD001 in Advanced Sarcoma
- Registration Number
- NCT01830153
- Lead Sponsor
- Asan Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description RAD001 RAD001 RAD001 was given as 10 mg orally once daily, and one cycle was defined as 28 days.
- Primary Outcome Measures
Name Time Method Progression-free survival rate at 16 weeks 16 weeks Determined as the proportion of progression-free (complete response, partial response and stable disease) at 16 weeks of treatment
- Secondary Outcome Measures
Name Time Method Progression-free survival Up to 24 months Defined as the time from the initiation of everolimus to disease progression or death, whichever occurred first.
Overall survival Up to 24 months Defined from the initiation of everolimus to death of any cause.
Response rate Up to 24 months Defined as the proportion of complete response and partial response per RECIST criteria.
Toxicity Up to 24 months Any adverse events occurred during the treatment with study drug.
Trial Locations
- Locations (8)
Seoul National University Bundang Hospital
🇰🇷Seongnam, Gyeonggi, Korea, Republic of
Asan Medical Center, University of Ulsan College of Medicine
🇰🇷Seoul, N/A = Not Applicable, Korea, Republic of
Yeongnam University College of Medicine
🇰🇷Daegu, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Korea University
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Yonsei Cancer Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of