Bone Sarcomas, Soft Tissue Sarcomas
Conditions
Keywords
Soft tissue sarcomas, Bone sarcomas, RAD001, Refractory to conventional chemotherapy
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.
Interventions
DRUGRAD001
Sponsors
Novartis
Asan Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed