Entry Detail
| General information | |
| Database: | DB00301 |
| Objective: | In the international, phase III, randomized, doubleblind CORRECT trial, regorafenib significantly prolonged overall survival (OS) versus placebo in patients with metastatic colorectal cancer (mCRC) that had progressed on all standard therapies. This post hoc analysis evaluated the efficacy and safety of regorafenib in Japanese and nonJapanese subpopulations in the CORRECT trial. |
| Authors: | Yoshino T, et al |
| Title: | Randomizedphase III trial of regorafenib in metastatic colorectal cancer: analysis of the CORRECT Japanese and nonJapanese subpopulations. |
| Journal: | Invest New Drugs |
| Year: | 2015 |
| PMID: | 25213161 |
| Trial Design | |
| Clinical Trial Id: | NCT01103323 |
| 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: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | an international, phase III, randomized, doubleblind CORRECT trial |
| Key Patients Feature: | Patients were eligible to participate when they had histological or cytological documentation of adenocarcinoma of the colon or rectum. Patients had to be aged 18 years or older and have an ECOG performance status of 0 or 1; life expectancy of at least 3 months; and adequate bonemarrow, liver, and renal function at the start of the trial. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | placebo |
| Treatment Info: | Patients were randomized 2 : 1 to regorafenib 160 mg once daily or placebo for weeks 13 of each 4week cycle. |
| Primary End Point: | OS (time from randomization to death from any cause) |
| Secondary End Point: | PFS, objective response rate (ORR), and disease control rate (DCR). Safety, healthrelated QoL, and PK |
| Patients Number: | 760 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | Regorafenib had a consistent OS benefit in the Japanese and nonJapanese subpopulations, with hazard ratios of 0.81 (95 % confidence interval [CI] 0.431.51) and 0.77 (95 % CI 0.620.94), respectively. |
| Adverse Event(agent arm): | Regorafenibassociated handfoot skin reaction, hypertension, proteinuria, thrombocytopenia, and lipase elevations occurred more frequently in the Japanese subpopulation than in the nonJapanese subpopulation, but were generally manageable. |
| Conclusions: | Regorafenib appears to have comparable efficacy in Japanese and nonJapanese subpopulations, with a manageable adverseevent profile, suggesting that this agent could potentially become a standard of care in patients with mCRC. |