| General information |
| Database: | DB00963 |
| Objective: | This study is a rare example of effective doses of both targeted agents being both administered and tolerated.This combination should not be used in melanoma. |
| Authors: | Sullivan RJ, et al |
| Title: | a phase I Trial of Bortezomib and Sorafenib in Advanced Malignant Melanoma. |
| Journal: | Oncologist. |
| Year: | 2015 |
| PMID: | 25986244 |
| Trial Design |
| Clinical Trial Id: | NCT01078961 |
| Agent: | Bortezomib and Sorafenib
|
| Target: | NA
|
| Cancer Type: | melanoma |
| Cancer Subtype: | advanced melanoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | Bortezomib+Sorafenib |
| Study Type: | a phase I Trial |
| Key Patients Feature: | Patients with metastatic melanoma |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | they aimed to combine sorafenib 400 mg b.i.d. with increasing doses of weekly bortezomib. |
| Primary End Point: | MTD, DLT, PFS and response rate |
| Secondary End Point: | NA |
| Patients Number: | 11 |
| Trial Results |
| DLT_MTD: | DLTs (fatigue and rash) were seen in two of three patients at the highest dose level. Five patients were enrolled for sorafenib 400 mg b.i.d. and bortezomib 1.0 mg/m2 weekly for 3 of every 4 weeks; none had DLTs, and this dose level was defined as the MTD. |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | NA |
| Conclusions: | The combination of sorafenib and bortezomib is safe but not active in patients with melanoma. |