RAD001 in Advanced Sarcoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|