drugset / Trial / NCT02116894

Safety Study of Regorafenib With PF-03446962 to Treat Colorectal Cancer

NCT02116894

Phase 1 Completed 11 enrolled Duke University Pfizer · collab
NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this open-label phase Ib trial is to determine the maximum tolerated dose and the recommended phase II dose for the combination of PF-03446962 plus regorafenib in patients with metastatic colorectal cancer. The secondary objectives are to describe the safety and tolerablility, and to describe the clinical activity of PF-03446962 plus regorafenib in terms of response rate and progression free survival

Timeline

Start
2014-08
Primary completion
2016-02
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Subject ASCRINVACUMAB Monoclonal antibody 4.5 mg/kg Intravenous
Subject ASCRINVACUMAB Monoclonal antibody 7 mg/kg Intravenous
Subject Regorafenib Small molecule 120 mg
Subject Regorafenib Small molecule 160 mg

Indications