Entry Detail
| General information | |
| Database: | DB00876 |
| Objective: | Inhibitors of vascular endothelial growth factor receptor (VEGFR) and epidermal growth factor receptor (EGFR) have shown antitumor activities in advanced hepatocellular carcinoma (hepatocellular carcinoma). The present study evaluated the efficacy and safety of vandetanib, an oral inhibitor of both VEGFR and EGFR, in patients with unresectable advanced hepatocellular carcinoma. |
| Authors: | Hsu C, et al |
| Title: | Vandetanib in patients with inoperable hepatocellular carcinoma: a phase II, randomized, doubleblind, placebocontrolled study. |
| Journal: | J Hepatol. |
| Year: | 2012 |
| PMID: | 22245891 |
| Trial Design | |
| Clinical Trial Id: | NCT00508001 |
| Agent: | vandetanib |
| Target: | Epidermal growth factor receptor Vascular endothelial growth factor receptor 2 Protooncogene tyrosineprotein kinase receptor ret |
| Cancer Type: | liver cancer |
| Cancer Subtype: | hepatocellular carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase II, randomized, doubleblind, placebocontrolled study. |
| Key Patients Feature: | Eligible patients had locally advanced or metastatic inoperable hepatocellular carcinoma with at least one measurable lesion by Response Evaluation Criteria In Solid Tumors (RECIST), version 1.0, and no treatment with curative intent was available. The diagnosis of hepatocellular carcinoma could be histological or clinical |
| Biomarker: | circulating proangiogenic factors and dynamic contrastenhanced magnetic resonance imaging |
| Biomark Analysis: | Vandetanib induced a significant increase in circulating VEGF and decrease in circulating VEGFR levels.DCEMRI did not detect significant vascular change after vandetanib treatment |
| Control Group Info: | vandetanib 300mg versus vandetanib 100mg versus placebo groups |
| Treatment Info: | Eligible patients were randomized 1:1:1 to receive vandetanib 300mg/day, vandetanib 100mg/day, or placebo. Upon disease progression, all patients had the option to receive openlabel vandetanib 300mg/day. |
| Primary End Point: | to evaluate tumor stabilization rate (complete response+partial response+stable disease 4 months). |
| Secondary End Point: | progression free survival (PFS), overall survival (OS) and safety |
| Patients Number: | 67 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | 0% |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 1.05 months (range 0.95-3.55) for V300, 1.7 months (range 0.95-1.87) for V100, and 0.95 months (range 0.92-1.87) for placebo. |
| Median OS A vs. C: | 5.75 months (range 4.50-10.17) for V100, 5.95 months (range 3.84-9.53) for V300, and 4.27 months (range 3.06-5.91) for placebo. |
| Adverse Event(agent arm): | The most common adverse events reported in the primary treatmentphase were diarrhea and rash, irrespective of randomized treatment (Table 4). |
| Conclusions: | Vandetanib has limited clinical activity in hepatocellular carcinoma. The safety profile was consistent with previous studies |