RAD001 in Advanced Sarcoma

Asan Medical Center

Status and phase

Completed

Phase 2

Conditions

Bone Sarcomas

Soft Tissue Sarcomas

Treatments

Drug: RAD001

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01830153

CRAD001CKR13T

Details and patient eligibility

About

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

Full 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.

Enrollment

41 patients

Sex

All

Ages

17+ years old

Volunteers

No Healthy Volunteers

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