Study of RAD001 in Adenoid Cystic Carcinoma (ACCRAD001)
- Although mTOR is clearly an attractive therapeutic target in tumor, no clinical study on mTOR inhibition by RAD001 has been systematically conducted in adenoid cystic carcinoma.
- In phase I study of RAD001, 2 patients with adenoid cystic carcinoma show some response to RAD001 (unpublished data).
- So the investigators design this phase II study of RAD001 in adenoid cystic carcinoma to evaluate the efficacy of RAD001 in this orphan disease.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study of RAD001monotherapy in Patients With Unresectable Adenoid Cystic Carcinoma|
- progression free survival rate at 4 months [ Time Frame: 10 months ]proportion of patients who are alive and progression-free at the time of 4 months of treatment among all patients
- the time to progression (TTP) [ Time Frame: 10 months ]
- overall survival (OS) [ Time Frame: 2 years ]
- response rate (RR) [ Time Frame: 6 months ]
- the metabolic response rate by PET-CT [ Time Frame: 2 months ]
|Study Start Date:||July 2008|
|Study Completion Date:||December 2012|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
RAD001 daily po medication
RAD001 10 mg po daily medication
Although the histologic appearance of adenoid cystic carcinoma is low grade, management of this malignancy is a distinct therapeutic challenge because of its insidious local growth pattern, propensity for perineural involvement, tendency for distant metastasis, and pronounced ability to recur over a prolonged period.
In prospectively performed clinical trials, objective responses to any cytotoxic agent or regimen are infrequent, whereas stabilization of disease was observed more commonly.
In adenoid cystic carcinoma, the study focusing on PI3-K/AKT/mTOR pathway is rare.
According to Younes MN et al's study, adenoid cystic carcinoma cell lines have increased pAkt activity when EGF-stimulation is added. And when treated with EGFR/VEGFR TK dual inhibitor, the phosphorylated form of Akt decreased despite of total level of Akt is remained unchanged.
When the investigators consider that the increased pAkt activity is one of possible predictor to mTOR inhibitor, the mTOR inhibitor might have an activity in adenoid cystic carcinoma.
Although mTOR is clearly an attractive therapeutic target in tumor, no clinical study on mTOR inhibition by RAD001 has been systematically conducted in adenoid cystic carcinoma.
In phase I study of RAD001, 2 patients with adenoid cystic carcinoma show some response to RAD001 (unpublished data).
So the investigators design this phase II study of RAD001 in adenoid cystic carcinoma to evaluate the efficacy of RAD001 in this orphan disease.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01152840
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Principal Investigator:||Yung-Jue Bang, MD, PhD||Seoul National University Hospital|
|Study Director:||Do-Youn Oh, MD,PhD||Seoul National University Hospital|