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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 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

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,696 Previous Clinical Trials
2,603,677 Total Patients Enrolled
Taiho Oncology, Inc.Industry Sponsor
78 Previous Clinical Trials
13,029 Total Patients Enrolled
IpsenIndustry Sponsor
350 Previous Clinical Trials
74,394 Total Patients Enrolled

Media Library

Nanoliposomal Irinotecan (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03368963 — Phase 1 & 2
Pancreatic Cancer Research Study Groups: Treatment (Nal-IRI, TAS-102)
Pancreatic Cancer Clinical Trial 2023: Nanoliposomal Irinotecan Highlights & Side Effects. Trial Name: NCT03368963 — Phase 1 & 2
Nanoliposomal Irinotecan (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03368963 — Phase 1 & 2
~0 spots leftby Nov 2024
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