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Study of Cabozantinib Plus TAS102 in mCRC as Salvage Therapy

Colorectal Cancer Clinical Trial

Official title:
A Phase 1 Study of the Combination of Cabozantinib With Trifluridine/Tipiracil (TAS-102) in Patients With Metastatic Colorectal Adenocarcinoma (mCRC)

Clinical Trial Summary

This is a phase I clinical trial assessing the safety and recommended phase II dose of cabozantinib in combination with trifluridine/tipiracil (TAS102) in patients with metastatic colorectal carcinoma (mCRC).

Clinical Trial Description

Patients with histologically proven colorectal adenocarcinoma not amenable to curative treatment will be eligible to participate for this study. After meeting the eligibility criteria, patients will be given a IP regimen consisting of cabozantinib 20 - 40 mg given orally everyday for 28 days, trifluridine/tipiracil (TAS102) 25 - 35 mg/m2 on Days 1 - 5 and Days 8 - 12 every 28 days, and peg-filgrastim 6 mg subcutaneously on Day 13 every 28 days. Tumor assessments will be completed by CT/MRI every 8 weeks during the first year of treatment and every 3 months after the first year until patient comes off treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04868773
Study type Interventional
Source University of California, Irvine
Contact
Status Active, not recruiting
Phase Phase 1
Start date July 16, 2021
Completion date February 2025
View Details
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