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

ConditionsColon Adenocarcinoma Colorectal Cancer

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of California, Irvine

About this trial

This is a phase 1b, prospective, single arm, non-randomized, open-label clinical trial determining the efficacy of adjuvant trifluridine and tipiracil (TAS-102) in combination with irinotecan in patients with ctDNA positive colon adenocarcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must have histologically or cytologically confirmed adenocarcinoma of the colon (high rectal cancer is eligible if resected and no radiation needed). Other histologies which are treated per NCCN guidelines for adjuvant colon cancer are eligible.

Must have Stage II, Stage III, or Stage IV colorectal cancer after curative intent resection eligible for adjuvant doublet chemotherapy for at least 3 months.

Must have ctDNA positive assay (tested by Signatera MRD assay) after at least 3 months of perioperative chemotherapy

Age ≥ 18 years

Disqualifiers

Patients who have had major surgery within 4 weeks, or chemotherapy or radiotherapy within 2 weeks prior to Cycle 1 Day 1

All toxicities attributed to prior anti-cancer therapy other than alopecia must have resolved to grade 1 or baseline

Patients may not be receiving any other investigational agents.

Patients with known metastases.

Trial design

Design model

Single group

Treatments tested in this trial

TAS-102
Drug
Given PO
Irinotecan
Drug
Given IV
Standard Treatment
Combination product
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
Signatera MRD ctDNA Assay
Diagnostic test
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)

Treatment groups

22 Participants

are divided into 1 treatment group

Group A: TASIRIExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

Percentage of ctDNA positivity in treatment cohort after 6 cycles or at least 3 months of adjuvant treatment

Percent of patients positive for ctDNA after 6 cycles or at least 3 months months after starting adjuvant treatment will be used to estimate the efficacy of adjuvant trifluridine and tipiracil (TAS102) in combination with irinotecan in patients with ctDNA positive colon adenocarcinoma. The Signatera MRD ctDNA Assay will be used to measure ctDNA positivity.

Time frame

6 months

Secondary outcomes

Percentage of Grade 3-5 Adverse Events

To evaluate the tolerability of drug-related grade 3-5 adverse events in patients with ctDNA positive colon adenocarcinoma. Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0.

Time frame

8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Irvine

Lead sponsor

Taiho Pharmaceutical Co., Ltd.

Collaborator

Natera, Inc.