drugset / Trial / NCT03099486

Regorafenib Plus 5-Fluorouracil/Leucovorin Beyond Progression in mCRC

NCT03099486 ↗

Phase 2 Terminated 2 enrolled Fox Chase Cancer Center
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2017-10-06
Primary completion
2020-06-02
Completion
2020-06-02

Outcome

Outcome not reported

Stopped: “Administrative change”

Drugs

EvaluationDrugModalityDoseRoute
Subject Regorafenib Small molecule 160 mg Oral
Background Leucovorin Small molecule 400 mg/m2 —
Background fluorouracil Small molecule 400 mg/m2 Other
Background fluorouracil Small molecule 2400 mg/m2 Other

Indications