PIT

Acronym: 

PIT

ACTRN/NCT /ethics: 

ACTRN12617001190392

Scientific title: 

An open label dose-finding, safety and tolerability study of Panitumumab, Irinotecan, Trifluridine/Tipiracil in RAS wild-type patients with metastatic colorectal cancer.

Summary of trial and patient characteristics

Trial Summary

This study aims to determine the maximum tolerated dose (MTD) and assess the efficacy of panitumumab, irinotecan and trifluridine/tipiracil when given in combination for participants with RAS/BRAF wild-type (WT) metastatic colorectal cancer (mCRC). Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a confirmed diagnosis of metastatic colorectal cancer that is RAS/BRAF wild type. Study details This study will be conducted in two parts: phase Ib and phase II. The study will commence with a phase Ib dose escalation phase, during which participants will be administered Irinotecan (180mg/m2) and Panitumumab (6mg/Kg) intravenously (IV) on Day 1 of every 14 day cycle, in combination with oral Trifluridine/tipiracil twice a day on Days 1-5 of every 14 day cycle. Dosing of trifluridine/Tipiracil will commence at 25 mg/m2 orally twice a day in the first group. If tolerated, the dose will be elevated for subsequent groups up to a maximum of 35 mg/m2 orally twice a day. Phase II of the study will enrol a separate group of participants who will receive the maximum tolerated dose determined in phase Ib. Treatment in both phases will continue until disease progression, unacceptable toxicity or participant withdrawal. Participants will be regularly assessed throughout the study in order to monitor safety and tumour response. Follow-up visits will occur every 12 weeks after the end of treatment visit until death or study closure. It is hoped that this study will provide evidence for further research into this combination, and improve health outcomes for patients with this disease.

Lay Summary

An open label dose-finding, safety and tolerability study of Panitumumab, Irinotecan, Trifluridine/Tipiracil in RAS wild-type patients with metastatic colorectal cancer.

Sponsor / Cooperative group

Participating Hospitals