Study of FOLFIRI + Panitumumab Using Ultra-selection Technology of Patients With Stage IV Colorectal Cancer Refractory to Irinotecan Without Any Mutation on KRAS, PIK3Ca, BRAF and NRAS Genes Detected With Highly Sensitive Techniques

Phase 2 Completed 72 enrolled Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

NaSingle-groupOpen-labelTreatment

Summary

Open label Phase II study of FOLFIRI + Panitumumab using ultra-selection technology with next generation high sensitivity genotyping of patients with stage IV colorectal cancer refractory to irinotecan without any mutation on KRAS, PIK3Ca, BRAF and NRAS genes detected with highly sensitive techniques.

Timeline

Start: 2012-10
Primary completion: 2016-07
Completion: 2016-07

Publications

Santos C, Azuara D, Vieitez JM, Paez D, Falco E, Elez E, Lopez-Lopez C, Valladares M, Robles-Diaz L, Garcia-Alfonso P, Buges C, Duran G, Salud A, Navarro V, Capella G, Aranda E, Salazar R. Phase II study of high-sensitivity genotyping of KRAS, NRAS, BRAF and PIK3CA to ultra-select metastatic colorectal cancer patients for panitumumab plus FOLFIRI: the ULTRA trial. Ann Oncol. 2019 May 1;30(5):796-803. doi: 10.1093/annonc/mdz082.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Panitumumab	Monoclonal antibody	6 mg/kg	Intravenous
Background	Irinotecan	Small molecule	180 mg/m2	Intravenous
Background	Leucovorin	Small molecule	400 mg/m2	Intravenous
Background	fluorouracil	Small molecule	400 mg/m2	Intravenous
Background	fluorouracil	Small molecule	2400 mg/m2	Intravenous

Study of FOLFIRI + Panitumumab Using Ultra-selection Technology of Patients With Stage IV Colorectal Cancer Refractory to Irinotecan Without Any Mutation on KRAS, PIK3Ca, BRAF and NRAS Genes Detected With Highly Sensitive Techniques

Summary

Timeline

Publications

Drugs

Indications