Trial in Metastatic Colorectal Cancer With FOLFIRI Plus Aflibercept as First Line Treatment

Phase 2 Unknown 31 enrolled Hellenic Oncology Research Group

NaSingle-groupOpen-labelTreatment

Summary

Investigators propose to study the combination of m FOLFIRI plus Aflibercept in a Phase II trial of patients with metastatic colorectal cancer. The promising results of aflibercept derived from preclinical studies and from clinical trials conducted in patients with refractory of recurrent to oxaliplatin-based 1st line treatment in patients with mCRC open the field to explore such therapeutic approaches in the 1st line setting in combination with the FOLFIRI regimen.

Timeline

Start: 2016-01
Primary completion: 2018-10
Completion: 2019-03

Publications

Matikas A, Souglakos J, Katsaounis P, Kotsakis A, Kouroupakis P, Pantazopoulos N, Kentepozidis N, Nikolaidi A, Messaritakis I, Tzovara I, Hatzidaki D, Prinarakis E, Georgoulias V. MINOAS: A Single-arm Translational Phase II Trial of FOLFIRI Plus Aflibercept as First-line Therapy in Unresectable, Metastatic Colorectal Cancer. Target Oncol. 2019 Jun;14(3):285-293. doi: 10.1007/s11523-019-00647-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aflibercept	Protein / enzyme biologic	4 mg/kg	Intravenous
Background	Irinotecan	Small molecule	180 mg/m2	Intravenous
Background	Leucovorin	Small molecule	400 mg/m2	Intravenous
Background	fluorouracil	Small molecule	2400 mg/m2	Intravenous

Trial in Metastatic Colorectal Cancer With FOLFIRI Plus Aflibercept as First Line Treatment

Summary

Timeline

Publications

Drugs

Indications