Spots Global Cancer Trial Database for Study of Cabozantinib Plus TAS102 in mCRC as Salvage Therapy
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Trial Identification
Brief Title: Study of Cabozantinib Plus TAS102 in mCRC as Salvage Therapy
Official Title: A Phase 1 Study of the Combination of Cabozantinib With Trifluridine/Tipiracil (TAS-102) in Patients With Metastatic Colorectal Adenocarcinoma (mCRC)
Study ID: NCT04868773
Study Description
Brief 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).
Detailed 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange, California, United States
Contact Details
Name: Farshid Dayyani, MD
Affiliation: Chao Family Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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