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Study of RAD001 in Adenoid Cystic Carcinoma

2014-07-23 21:08:39 | BioPortfolio

Summary

- 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- In phase I study of RAD001, 2 patients with adenoid cystic carcinoma show some response to RAD001 (unpublished data).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.

Description

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In phase I study of RAD001, 2 patients with adenoid cystic carcinoma show some response to RAD001 (unpublished data).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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Adenoid Cystic Carcinoma

Intervention

RAD001

Location

Seoul National University Hospital
Seoul
Korea, Republic of
110-744

Status

Recruiting

Source

Seoul National University Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:39-0400

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