RAD001 in Advanced Sarcoma

Asan Medical Center41 enrolled

Overview

This trial intends to test the efficacy and safety of RAD001 in patients with advanced sarcoma who failed to conventional chemotherapy.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Soft Tissue Sarcomas Bone Sarcomas

Interventions

RAD001DRUG

Eligibility

Sex: ALLMin age: 17 Years

Medical Language ↔ Plain English

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

Locations (8)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Asan Medical Center, University of Ulsan College of Medicine

Seoul, N/A = Not Applicable, South Korea

Yeongnam University College of Medicine

Daegu, South Korea

Chungnam National University Hospital

Daejeon, South Korea

Outcomes

Primary Outcomes

Progression-free survival rate at 16 weeks

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

Time frame: 16 weeks

Secondary Outcomes

Progression-free survival

Defined as the time from the initiation of everolimus to disease progression or death, whichever occurred first.

Time frame: Up to 24 months

Overall survival

Defined from the initiation of everolimus to death of any cause.

Time frame: Up to 24 months

Response rate

Defined as the proportion of complete response and partial response per RECIST criteria.

Time frame: Up to 24 months

Toxicity

Any adverse events occurred during the treatment with study drug.

Time frame: Up to 24 months

Data from ClinicalTrials.gov

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