NCT01152840

Study of RAD001 in Adenoid Cystic Carcinoma

Phase II Study of RAD001monotherapy in Patients With Unresectable Adenoid Cystic Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 * In phase I study of RAD001, 2 patients with adenoid cystic carcinoma show some response to RAD001 (unpublished data).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

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 In phase I study of RAD001, 2 patients with adenoid cystic carcinoma show some response to RAD001 (unpublished data).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

Conditions

• Adenoid Cystic Carcinoma

Interventions

Type	Name	Description
DRUG	RAD001	RAD001 10 mg po daily medication * Treatments will be continued until any of the following events occur: * progression of disease, * the subject develops unacceptable toxicity, * consent to participate in the study is withdrawn.

Timeline

• Start date: 2008-07-01
• Primary completion: 2011-05-01
• Completion: 2012-12-01
• First posted: 2010-06-29
• Last updated: 2015-05-20

Locations

1 site across 1 country: South Korea