Study of ctDNA Guided Change in Tx for Refractory Minimal Residual Disease in Colon Adenocarcinomas

PHASE1RecruitingINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

August 26, 2021

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Colon AdenocarcinomaColorectal Cancer
Interventions
DRUG

TAS-102

Given PO

DRUG

Irinotecan

Given IV

COMBINATION_PRODUCT

Standard Treatment

6 cycles for a 2-week regimen (infusional 5FU based) and up to 4 cycles for a 3-week regimen (oral capecitabine based) after randomization

DIAGNOSTIC_TEST

Signatera MRD ctDNA Assay

To be performed within 6-8 weeks of Cycle 1 Day 1. A Mid-treatment ctDNA is to be completed within 6 - 8 weeks of starting treatment. ctDNA is to also be completed within four weeks after completion of study treatment (+/- two weeks)

Trial Locations (1)

92868

RECRUITING

Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Taiho Pharmaceutical Co., Ltd.

INDUSTRY

collaborator

Natera, Inc.

INDUSTRY

lead

University of California, Irvine

OTHER

NCT04920032 - Study of ctDNA Guided Change in Tx for Refractory Minimal Residual Disease in Colon Adenocarcinomas | Biotech Hunter | Biotech Hunter