RAD001 in Advanced Sarcoma

Sponsor

Asan Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01830153

Collaborator

Novartis (Industry)

Enrollment

Locations

Arm

5.1

Patients Per Site

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Soft Tissue Sarcomas Bone Sarcomas	Drug: RAD001	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Multicenter Trial of RAD001 in Patients With Metastatic or Recurrent Sarcomas

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RAD001 RAD001 was given as 10 mg orally once daily, and one cycle was defined as 28 days.	Drug: RAD001 Other Names: Everolimus

Arm

Intervention/Treatment

Experimental: RAD001

RAD001 was given as 10 mg orally once daily, and one cycle was defined as 28 days.

Drug: RAD001

Other Names:

Everolimus

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam	Gyeonggi	Korea, Republic of	463-707
2	Asan Medical Center, University of Ulsan College of Medicine	Seoul	N/A = Not Applicable	Korea, Republic of	138-736
3	Yeongnam University College of Medicine	Daegu		Korea, Republic of
4	Chungnam National University Hospital	Daejeon		Korea, Republic of	301-721
5	Seoul National University Hospital	Seoul		Korea, Republic of	110-744
6	Yonsei Cancer Center	Seoul		Korea, Republic of	120-752
7	Korea University	Seoul		Korea, Republic of	126-1
8	Samsung Medical Center	Seoul		Korea, Republic of	135-710