NCT01929616

Regorafenib Assessment in Refractory Advanced Colorectal Cancer(RegARd-C)

Regorafenib Assessment in Refractory Advanced Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Jules Bordet Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The general objectives are to evaluate activity and the safety of regorafenib in a population of patients bearing advanced, refractory colorectal cancers and to explore the different downstream molecular pathways to identify tumor response and resistance mechanisms.

Detailed description

The primary objective is to identify in a population of patients bearing advanced, refractory colorectal cancers, those who draw no benefit from treatment with regorafenib. There is no specific hypothesis underlying sample size and the study is therefore to be seen as exploratory. Secondary objectives: * To analyze PFS and response rate (RR) in relationship with the same covariates as for OS * To assess regorafenib efficacy (OS, PFS, RR) and safety profile in this study population. * To assess the Disease control rate (DCR = Complete response \[CR\] + partial response \[PR\] + stable disease \[SD\]) * To compare the relative benefit (OS, PFS) of regorafenib according to history of treatment with bevacizumab.

Conditions

• Advanced Chemorefractory Colorectal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	regorafenib	Patients will receive 160 mg regorafenib 1/day 3 weeks out of 4.

Timeline

• Start date: 2013-08-01
• Primary completion: 2016-05-13
• Completion: 2019-06-17
• First posted: 2013-08-28
• Last updated: 2019-06-25

Locations

17 sites across 1 country: Belgium