Phase II Randomized Study Evaluating the Efficacy of Panitumumab (VEctibix ) and Trifluridine-Tipiracil (LOnsurf) in Pretreated RAS Wild Type Metastatic Colorectal Cancer Patients: the VELO Trial

PHASE2CompletedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

October 29, 2019

Primary Completion Date

May 31, 2022

Study Completion Date

June 30, 2022

Conditions
Metastatic Colon Cancer
Interventions
DRUG

Trifluridine Tipiracil

"Trifluridine-Tipiracil will be administered at 35 mg per square meter orally twice daily, with a glass of water within 1 hour after completion of morning and evening meals, 5 days a week, with 2 days of rest, for 2 weeks, followed by a 14-day rest period. One treatment cycle with Trifluridine-Tipiracil consists of the following:~Days 1-5: Trifluridine / Tipiracil (35 mg/m2/dose) orally twice daily Days 6-7: Rest Days 8-12: Trifluridine / Tipiracil(35mg/m²/dose) orally twice daily Days 13-28: Rest"

DRUG

Panitumumab 20 MG/1 ML Intravenous Solution [VECTIBIX]

Panitumumab will be administered as a 6 mg/kg intravenous infusion over 60 minutes every 2 weeks (q2w) of a 28-day cycle (Day 1 and Day 15).

Trial Locations (8)

80131

AORN-Ospedale dei colli, UOC Oncologia, Napoli

Unknown

A.O.U. Cagliari - Presidio Policlinico D. Casula, Monserrato

A.O.U. Pisana, Pisa

A.R.N.A.S. Garibaldi - P.O. GaribaldiNesima, Catania

Istituto Europeo di Oncologia, Milan

"A.O.U. dell'Università degli studi della Campania Luigi Vanvitelli", Napoli

"IRCCS Istituto Nazionale Tumori Fondazione G. Pascale", Napoli

Universiyà Campus-Biomedico, Roma

All Listed Sponsors
lead

University of Campania Luigi Vanvitelli

OTHER

NCT05468892 - Phase II Randomized Study Evaluating the Efficacy of Panitumumab (VEctibix ) and Trifluridine-Tipiracil (LOnsurf) in Pretreated RAS Wild Type Metastatic Colorectal Cancer Patients: the VELO Trial | Biotech Hunter | Biotech Hunter