Entry Detail
| General information | |
| Database: | DB00296 |
| Objective: | The oral multikinase inhibitor regorafenib improves overall survival (OS) in patients with metastatic colorectal cancer (CRC) for which all standard treatments have failed. This study investigated regorafenib plus modified FOLFOX (mFOLFOX6) as firstline treatment of metastatic CRC. |
| Authors: | Argil¨¦s G, et al |
| Title: | Regorafenib plus modified FOLFOX6 as firstline treatment of metastatic colorectal cancer: a phase II trial. |
| Journal: | Eur J Cancer. |
| Year: | 2015 |
| PMID: | 25818084 |
| Trial Design | |
| Clinical Trial Id: | NCT01289821 |
| Agent: | regorafenib |
| Target: | Protooncogene tyrosineprotein kinase receptor ret Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 Vascular endothelial growth factor receptor 3 |
| Cancer Type: | colorectal cancer |
| Cancer Subtype: | advanced colorectal cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Regorafenib+ modified FOLFOX6 |
| Study Type: | an international, multicentre, singlearm, openlabel, phase II exploratory study |
| Key Patients Feature: | Patients had to be at least 18 years old, with histological or cytological documentation of adenocarcinoma of the colon or rectum, and had to be suitable to receive firstline treatment with mFOLFOX6 for metastatic disease. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | patients received mFOLFOX6 on days 1 and 15, and regorafenib 160 mg orally once daily on days 410 and 1824 of each 28day cycle. |
| Primary End Point: | objective response rate (ORR). |
| Secondary End Point: | disease control rate (DCR), OS, progression free survival (PFS) and safety. |
| Patients Number: | 66 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | Fiftythree patients received at least one dose of regorafenib. ORR was 43.9% (all partial responses); |
| Disease Control Rate: | 0.854 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 8.5 months |
| Median OS A vs. C: | median OS was not reached |
| Adverse Event(agent arm): | Treatmentemergent adverse events were experienced by all patients but were manageable with dose modifications. |
| Conclusions: | Regorafenib+mFOLFOX6 as firstline treatment in patients with metastatic CRC did not improve ORR over historical controls. Regorafenib plus mFOLFOX6 did not appear to be associated with a markedly worse tolerability profile versus mFOLFOX6 alone. |