CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 68 enrolled
Drug / intervention
Trifluridine Tipiracil +1 moredrug
Likely dose
Panitumumab 20 MG/1 ML Intravenous Solution [VECTIBIX]from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05468892
NCT05468892Phase 2Completed
CompareCT.gov

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

University of Campania Luigi Vanvitelli·interventional·Posted Jul 21, 2022·Updated Feb 1, 2024

In Brief

A Phase 2 clinical trial evaluating Trifluridine Tipiracil and Panitumumab 20 MG/1 ML Intravenous Solution [VECTIBIX] for Metastatic Colon Cancer. Completed, enrolled 68 participants across 8 sites.

Detailed Summary

This is a randomized phase II, open label, two arm study, evaluating the efficacy of panitumumab in combination with Trifluridine-Tipiracilas third line therapy, after a first line containing an anti-EGFR agent panitumumab(at least 70% of study population) or cetuximab in metastatic colorectal cancer (mCRC) patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Colon Cancer
CountriesItaly
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJul 21, 2022
Enrollment StartOct 29, 2019
Primary CompletionMay 31, 2022
Study CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 3.9 years ago

Interventions

Trifluridine Tipiracildrug

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

Panitumumab 20 MG/1 ML Intravenous Solution [VECTIBIX]drug

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).