RAD001 in Advanced Sarcoma
|ClinicalTrials.gov Identifier: NCT01830153|
Recruitment Status : Completed
First Posted : April 12, 2013
Last Update Posted : April 12, 2013
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcomas Bone Sarcomas||Drug: RAD001||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Multicenter Trial of RAD001 in Patients With Metastatic or Recurrent Sarcomas|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||January 2013|
RAD001 was given as 10 mg orally once daily, and one cycle was defined as 28 days.
Other Name: Everolimus
- Progression-free survival rate at 16 weeks [ Time Frame: 16 weeks ]Determined as the proportion of progression-free (complete response, partial response and stable disease) at 16 weeks of treatment
- Progression-free survival [ Time Frame: Up to 24 months ]Defined as the time from the initiation of everolimus to disease progression or death, whichever occurred first.
- Overall survival [ Time Frame: Up to 24 months ]Defined from the initiation of everolimus to death of any cause.
- Response rate [ Time Frame: Up to 24 months ]Defined as the proportion of complete response and partial response per RECIST criteria.
- Toxicity [ Time Frame: Up to 24 months ]Any adverse events occurred during the treatment with study drug.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830153
|Korea, Republic of|
|Seoul National University Bundang Hospital|
|Seongnam, Gyeonggi, Korea, Republic of, 463-707|
|Asan Medical Center, University of Ulsan College of Medicine|
|Seoul, N/A = Not Applicable, Korea, Republic of, 138-736|
|Yeongnam University College of Medicine|
|Daegu, Korea, Republic of|
|Chungnam National University Hospital|
|Daejeon, Korea, Republic of, 301-721|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Yonsei Cancer Center|
|Seoul, Korea, Republic of, 120-752|
|Seoul, Korea, Republic of, 126-1|
|Samsung Medical Center|
|Seoul, Korea, Republic of, 135-710|
|Principal Investigator:||Jin-Hee Ahn, MD, PhD||Asan Medical Center|