| General information |
| Database: | DB00893 |
| Objective: | Brivanib, a selective dual inhibitor of fibroblast growth factor and VEGF signaling, has recently been shown to have activity as firstline treatment for patients with advanced hepatocellular carcinoma (hepatocellular carcinoma). Thisphase II openlabel study assessed brivanib as secondline therapy in patients with advanced hepatocellular carcinoma who had failed prior antiangiogenic treatment |
| Authors: | Finn RS, et al |
| Title: | Phase II, openlabel study of brivanib as secondline therapy in patients with advanced hepatocellular carcinoma. |
| Journal: | Clin Cancer Res. |
| Year: | 2012 |
| PMID: | 22238246 |
| Trial Design |
| Clinical Trial Id: | NCT00355238 |
| Agent: | brivanib
|
| Target: | vascularendothelial growth factor and fibroblast growth factor receptors
|
| Cancer Type: | liver cancer |
| Cancer Subtype: | advanced hepatocellular carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | phase II openlabel study |
| Key Patients Feature: | patients with unresectable, locally advanced, and/or metastatic hepatocellular carcinoma who had received 1 prior antiangiogenic therapy regimen |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Brivanib was administered orally at a dose of 800 mg once daily |
| Primary End Point: | tumor response rate, time to response, duration of response, progression free survival, overall survival (OS), disease control rate, time to progression (TTP), and safety and tolerability. |
| Secondary End Point: | NA |
| Patients Number: | 46 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 4.30% |
| Disease Control Rate: | 45.70% |
| Median Time to Progression: | secondline treatment with brivanib was 2.7 months. |
| Median PFS A vs. C: | 2.00 months (95% CI: 1.41-3.91) assessed by IRRC and 2.73 months (95% CI: 1.45-4.04) assessed by study investigators. |
| Median OS A vs. C: | 9.79 months (95% CI: 5.52-13.17) |
| Adverse Event(agent arm): | The most common adverse events were fatigue, decreased appetite, nausea, diarrhea, and hypertension. |
| Conclusions: | Brivanib had a manageable safety profile and is one of the first agents to show promising antitumor activity in advanced hepatocellular carcinoma patients treated with prior sorafenib. |