NCT03227926: CHRONOS

Rechallenge With Panitumumab Driven by RAS Dynamic of Resistance

Completed Phase 2 Last updated 25 August 2022

What this trial tests

Phase 2 trial testing Panitumumab 20 MG/ML Intravenous Solution [VECTIBIX] in Colorectal Cancer in 32 participants. Completed in 31 December 2021.

Timeline

11 October 2017

Primary endpoint
6 November 2019

31 December 2021

Quick facts

Lead sponsor	Fondazione del Piemonte per l'Oncologia
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	11 October 2017
Primary completion	6 November 2019
Estimated completion	31 December 2021
Sites	4 locations across Italy

Drugs / interventions tested

• Panitumumab 20 MG/ML Intravenous Solution [VECTIBIX] — full drug profile →
• Molecular Screening

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

Fondazione del Piemonte per l'Oncologia — full company profile →

Who can join

18 and older, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Rechallenge for Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer With Acquired Resistance to First-line Cetuximab and Irinotecan: A Phase 2 Single-Arm Clinical Trial.
   Cremolini C, Rossini D, Dell'Aquila E, Lonardi S, et al · · 2019 · cited 310× · PMID 30476968 · DOI 10.1001/jamaoncol.2018.5080
2. ctDNA applications and integration in colorectal cancer: an NCI Colon and Rectal-Anal Task Forces whitepaper.
   Dasari A, Morris VK, Allegra CJ, Atreya C, et al · · 2020 · cited 281× · PMID 32632268 · DOI 10.1038/s41571-020-0392-0
3. Circulating tumor DNA to guide rechallenge with panitumumab in metastatic colorectal cancer: the phase 2 CHRONOS trial.
   Sartore-Bianchi A, Pietrantonio F, Lonardi S, Mussolin B, et al · · 2022 · cited 202× · PMID 35915157 · DOI 10.1038/s41591-022-01886-0
4. Longitudinal Liquid Biopsy and Mathematical Modeling of Clonal Evolution Forecast Time to Treatment Failure in the PROSPECT-C Phase II Colorectal Cancer Clinical Trial.
   Khan KH, Cunningham D, Werner B, Vlachogiannis G, et al · · 2018 · cited 181× · PMID 30166348 · DOI 10.1158/2159-8290.cd-17-0891
5. Integrating circulating-free DNA (cfDNA) analysis into clinical practice: opportunities and challenges.
   García-Pardo M, Makarem M, Li JJN, Kelly D, et al · · 2022 · cited 94× · PMID 35347327 · DOI 10.1038/s41416-022-01776-9
6. Circulating tumor DNA to monitor treatment response in solid tumors and advance precision oncology.
   Bartolomucci A, Nobrega M, Ferrier T, Dickinson K, et al · · 2025 · cited 72× · PMID 40122951 · DOI 10.1038/s41698-025-00876-y
7. Research progress of CTC, ctDNA, and EVs in cancer liquid biopsy.
   Wang X, Wang L, Lin H, Zhu Y, et al · · 2024 · cited 54× · PMID 38333685 · DOI 10.3389/fonc.2024.1303335
8. The Evolving Biomarker Landscape for Treatment Selection in Metastatic Colorectal Cancer.
   Taieb J, Jung A, Sartore-Bianchi A, Peeters M, et al · · 2019 · cited 49× · PMID 31347092 · DOI 10.1007/s40265-019-01165-2