NCT04008511

Regorafenib and XELOX as 2nd Line Treatment in Metastatic Colorectal Cancer

Phase Ib/II Study of Regorafenib and XELOX Combination as 2nd Line Treatment in Metastatic Colorectal Cancer Patients

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: China Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an interventional, randomized open-label, parallel-group, multicenter, dose escalation phase Ib/II study, to investigate the combination of Regorafenib and XELOX as 2nd line treatment in mCRC patients.

Detailed description

This is a phase Ib/II trial, comprising Phase Ib and Phase II two parts. Phase Ib study is an open-label, single-arm, multicenter, dose escalation study of Regorafenib plus XELOX. In Phase Ib, max 15 patients(pts) could be enrolled based on the modified toxicity probability interval (mTPI) design. Phase II study is a randomized, open-label, parallel-group, multicenter study comparing Regorafenib + XELOX to XELOX alone. In phase II trial, a total of 39 patients will be recruited and randomized 2:1 into two groups, where 26 patients under Regorafenib + XELOX, and 13 patients under XELOX alone.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Regorafenib	Phase Ib Group A: Regorafenib 120mg + XELOX; Group B: Regorafenib 160mg + XELOX; Group C: Regorafenib 80mg + XELOX.
DRUG	Regorafenib	Phase II: Regorafenib MAD qd po for 14 days, every 3 weeks.
DRUG	Capecitabine	Capecitabine 1000 mg/m2 bid po for 14 days.
DRUG	Oxaliplatin	Oxaliplatin 130mg/m2, day 1, every 3 weeks

Timeline

• Start date: 2019-07-01
• Primary completion: 2023-03-01
• Completion: 2024-03-01
• First posted: 2019-07-05
• Last updated: 2019-07-05

Locations

1 site across 1 country: China