NCT03099486

Regorafenib Plus 5-Fluorouracil/Leucovorin Beyond Progression in mCRC

A Pilot Phase II, Single Arm, Open Label, Investigator-initiated Clinical Trial of Regorafenib Plus 5-Fluorouracil/Leucovorin (5FU/LV) Beyond Progression on Regorafenib Monotherapy in Metastatic Colorectal Cancer (mCRC)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm open label pilot phase II trial of Regorafenib PO plus 5-FU/LV infusion in 15 mCRC patients who progressed on prior Regorafenib monotherapy as well as 5-FU containing chemotherapy combinations.The study will enroll mCRC patients with prior progression on standard multi-agent combination chemotherapy and progression on regorafenib monotherapy.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Regorafenib	The dose of Regorafenib is 160 mg PO daily D1-D21 of 28-day cycle or last tolerated dose while on Regorafenib monotherapy.
DRUG	5-FU	5-FU dose D1 and D15 of 28 day cycle i400 mg/m2 bolus over 10 mins followed by 2400 mg/m2 continuous infusion over 46 hours
DRUG	Leucovorin	D1 and D15 of 28 day cycle Leucovorin 400 mg/m2 over 2 hours,

Timeline

• Start date: 2017-10-06
• Primary completion: 2020-06-02
• Completion: 2020-06-02
• First posted: 2017-04-04
• Last updated: 2022-02-07
• Results posted: 2022-02-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study