NCT02619435

Regorafenib Monotherapy as Second-line Treatment of Patients With RAS-mutant Advanced Colorectal Cancer

Regorafenib Monotherapy as Second-line Treatment of Patients With RAS-mutant Advanced Colorectal Cancer: a Multicentre, Single-arm, Two-stage, Phase 2 Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to purpose of this study is to assess if regorafenib is active enough, in terms of 6-month progression-free rate, to warrant further comparative studies in patients with RAS-mutant advanced colorectal cancer who have progressed after first-line oxaliplatin-based chemotherapy plus bevacizumab.

Conditions

• Advanced Colorectal Cancer

Interventions

Type	Name	Description
DRUG	regorafenib	Patients will receive regorafenib orally 160 mg once daily for the first 3 weeks of each 4-week cycle.

Timeline

• Start date: 2015-11-01
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2015-12-02
• Last updated: 2023-03-24

Locations

4 sites across 1 country: Italy