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Rechallenge With Panitumumab Driven by RAS Dynamic of Resistance

NCT03227926 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-08-25

No results posted yet for this study

Summary

This is a hypothesis driven, open label, single-arm, multiple centers, Phase II trial. The trial has been designed to prove or disprove whether a rechallenge with panitumumab can achieve an objective response rate (ORR= CR+PR) of 30% or more in a population of RAS wild type mCRC patients selected on the basis of RAS extended clonal evolution in their plasma.

Conditions

Interventions

DRUG

Panitumumab 20 MG/ML Intravenous Solution [VECTIBIX]

Panitumumab 6 mg/kg in 100 cc 0.9% NaCl solution on Day 1 every two weeks by IV administration over 1 hour.

DIAGNOSTIC_TEST

Molecular Screening

Patients without plasmatic evidence of potentially resistant clones harbouring RAS or EGFR-ectodomain mutations in the RML liquid biopsy, will be molecular eligible for the trial phase

Sponsors & Collaborators

  • Fondazione del Piemonte per l'Oncologia

    lead OTHER

Principal Investigators

  • Salvatore Siena, MD · Grande Ospedale Metropolitano Niguarda - Milano

  • Alberto Bardelli, MD · Fondazione del Piemonte per l'Oncologia

  • Silvia Marsoni, MD · Fondazione del Piemonte per l'Oncologia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-11
Primary Completion
2019-11-06
Completion
2021-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03227926 on ClinicalTrials.gov