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Anti-tumor antibiotic

TAS-102 + Nanoliposomal Irinotecan for Gastrointestinal Cancer

Phase 1 & 2

Recruiting

Led By Olatunji B. Alese, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

Adequate renal function as evidenced by a serum creatinine ≤ 1.5 x upper limit of normal (ULN)

Must not have

New York Heart Association (NYHA) class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure

Investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years after end of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the best dose and how well trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) and nanoliposomal irinotecan work in treating patients with gastrointestinal cancers that have spread to other places in the body (metastatic) or cannot be removed by surgery.

Who is the study for?

This trial is for adults with advanced gastrointestinal cancers that are metastatic or can't be surgically removed. Participants must have tried at least one prior therapy, have measurable disease per RECIST 1.1, and adequate organ function. They should not have had irinotecan before (for certain phases), no recent severe heart issues or infections, and cannot be pregnant or breastfeeding.

What is being tested?

The trial is testing the combination of TAS-102 (trifluridine/tipiracil hydrochloride) and nanoliposomal irinotecan to find the best dose and see how well it works against various gastrointestinal cancers by stopping tumor growth.

What are the potential side effects?

Potential side effects may include typical chemotherapy-related reactions such as nausea, vomiting, diarrhea, fatigue, decreased appetite, neutropenia (low white blood cell count), which increases infection risk; anemia (low red blood cell count); thrombocytopenia (low platelet count); liver enzyme elevation; and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My kidney function is within the normal range.

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I need a new biopsy for my condition before joining the study.

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I have tried at least one standard treatment for my advanced cancer but it didn't work or I couldn't tolerate it.

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My white blood cell count is healthy without needing medication to boost it.

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My liver function tests are within the required limits.

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I have advanced gastrointestinal cancer and previous treatments didn't work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe heart issues or uncontrolled blood pressure.

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I haven't taken any experimental drugs recently.

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I cannot take medications by mouth.

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I am allergic to nal-IRI, liposomal products, fluoropyrimidines, or leucovorin.

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I have a history of DPD deficiency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years after end of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years after end of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years after end of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events of trifluridine/tipiracil hydrochloride combination agent TAS-102 in combination with nanoliposomal irinotecan

Overall response rate based on modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Secondary study objectives

Progression free survival

Response duration

Response rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (Nal-IRI, TAS-102)Experimental Treatment2 Interventions

Patients receive nanoliposomal irinotecan IV over 90 minutes on day 1 and combination of trifluridine/tipiracil hydrochloride combination agent TAS-102 PO BID on days 1-5. Cycles repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trifluridine and Tipiracil Hydrochloride

2019

Completed Phase 2

~180

Nanoliposomal Irinotecan

2019

Completed Phase 1

~50