| General information |
| Database: | DB00901 |
| Objective: | Treatments that target the vascular endothelial growth factor (VEGF) pathway have efficacy in colorectal cancer. they evaluated tolerability and efficacy of tivozanib (an oral VEGF receptor1, 2, 3 inhibitor) plus everolimus (an oral mammalian target of rapamycin inhibitor). |
| Authors: | Wolpin BM, et al |
| Title: | Multicenterphase II study of tivozanib (AV951) and everolimus (RAD001) for patients with refractory, metastatic colorectal cancer. |
| Journal: | Oncologist |
| Year: | 2013 |
| PMID: | 23580238 |
| Trial Design |
| Clinical Trial Id: | NCT01058655 |
| Agent: | tivozanib (AV951) and everolimus (RAD001)
|
| Target: | NA
|
| Cancer Type: | colorectal cancer |
| Cancer Subtype: | advanced colorectal cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | tivozanib (AV951)+everolimus (RAD001) |
| Study Type: | Multicenterphase II study |
| Key Patients Feature: | patients with refractory, metastatic colorectal cancer. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | this study followed a 3 + 3 doseescalation design with three dose levels |
| Primary End Point: | improvement in 2month progression free survival (PFS) from 30% (historical benchmark) to 50% |
| Secondary End Point: | NA |
| Patients Number: | 40 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | 50% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 3.0 months (95% confidence interval [CI]: 1.93.6 months) |
| Median OS A vs. C: | 5.6 months (95% CI: 4.410.6 months) |
| Adverse Event(agent arm): | The most common grade 3-4 adverse events were thrombocytopenia and hypophosphatemia. |
| Conclusions: | The oral combination of tivozanib and everolimus was well tolerated, with stable disease achieved in 50% of patients with refractory, metastatic colorectal cancer |