| General information |
| Database: | DB00759 |
| Objective: | The aim of this study was to examine the efficacy and safety of everolimus in patients with progressive unresectable adenoid cystic carcinoma (ACC). |
| Authors: | Kim DW, et al |
| Title: | A multicenterphase II study of everolimus in patients with progressive unresectable adenoid cystic carcinoma. |
| Journal: | BMC Cancer. |
| Year: | 2014 |
| PMID: | 25362970 |
| Trial Design |
| Clinical Trial Id: | NCT01152840 |
| Agent: | everolimus
|
| Target: | Serine/threonineprotein kinase mTOR
|
| Cancer Type: | advanced adenoid cystic carcinoma |
| Cancer Subtype: | advanced adenoid cystic carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | A multicenterphase II study |
| Key Patients Feature: | Histologically confirmed ACC patients with documented disease progression within 12 months prior to the study entry were eligible |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Everolimus was given at a dose of 10 mg daily until progression or occurrence of unacceptable toxicities |
| Primary End Point: | a 4month progression free survival (PFS) |
| Secondary End Point: | NA |
| Patients Number: | 34 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 11.2 months (95% CI, 3.6 to 15.8) |
| Median OS A vs. C: | 23.7 months (95% CI, 6.8 to 40.6). |
| Adverse Event(agent arm): | The most common adverse events were stomatitis, anemia, asthenia, and leukopenia. No unexpected everolimus related toxicities were reported. |
| Conclusions: | Everolimus showed promising efficacy and good tolerability in progressive unresectable ACC. |