| General information |
| Database: | DB01008 |
| Objective: | This multicenter, phase II trial evaluated the efficacy and safety of everolimus, an mTOR inhibitor, in patients with metastatic or recurrent bone and softtissue sarcoma after the failure of anthracycline and ifosfamidecontaining regimens. |
| Authors: | Yoo C, et al |
| Title: | Multicenterphase II study of everolimus in patients with metastatic or recurrent bone and softtissue sarcomas after failure of anthracycline and ifosfamide. |
| Journal: | Invest New Drugs. |
| Year: | 2013 |
| PMID: | 24037083 |
| Trial Design |
| Clinical Trial Id: | NCT01830153 |
| Agent: | everolimus
|
| Target: | Serine/threonineprotein kinase mTOR
|
| Cancer Type: | soft tissue sarcomas |
| Cancer Subtype: | bone and softtissue sarcomas |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | multicenter, phase II trial |
| Key Patients Feature: | patients with metastatic or recurrent bone and softtissue sarcomas after failure of anthracycline and ifosfamide. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Everolimus was administered orally as 10 mg once daily. |
| Primary End Point: | the progression free rate (PFR) at 16 weeks, assessed by computed tomography scan according to RECIST v1.0. |
| Secondary End Point: | NA |
| Patients Number: | 38 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 1.9 months (95% CI, 1.32.4 months) |
| Median OS A vs. C: | 5.8 months (95% CI, 3.68.0 months) |
| Adverse Event(agent arm): | Most adverse events were generally mild and tolerable. Grade 3/4 toxicities included hyperglycemia (15 %), stomatitis (7 %), pain (5 %), and asthenia (5 %). |
| Conclusions: | Everolimus shows modest antitumor activity with manageable toxicities in heavily pretreated patients with bone and softtissue sarcoma |