drugset / Trial / NCT01310478

Recombinant Human Endostatin in Combination With mFOLFOX6 in Patients With Metastatic Colorectal Cancer

NCT01310478

Phase 1 Unknown 15 enrolled Fudan University
Non-randomizedSingle-groupOpen-labelTreatment

Summary

To investigate safety and tolerance of dose-escalation of infusional recombinant human endostatin in combination with mFOLFOX6 as initial therapy for patients with metastatic colorectal cancer.

Timeline

Start
2010-08
Primary completion
2011-05
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Endostar Protein / enzyme biologic 7.5 mg/m2 Intravenous
Subject Endostar Protein / enzyme biologic 45 mg/m2 Intravenous
Background Leucovorin Small molecule 400 mg/m2
Background Oxaliplatin Small molecule 85 mg/m2
Background fluorouracil Small molecule 2.4 unknown
Background fluorouracil Small molecule 400 mg/m2

Indications