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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
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 belowSelect...
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:Select...
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
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
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
1,679 Previous Clinical Trials
2,583,602 Total Patients Enrolled
Taiho Oncology, Inc.Industry Sponsor
78 Previous Clinical Trials
13,056 Total Patients Enrolled
IpsenIndustry Sponsor
349 Previous Clinical Trials
73,738 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe heart issues or uncontrolled blood pressure.Your platelet count is at least 100,000 per microliter within 14 days before starting treatment.Your albumin levels in your blood are at least 3.0 grams per deciliter within 14 days before starting the treatment.I have been cancer-free for 5 years, except for in-situ, basal, or squamous cell skin cancer.I haven't had a severe heart attack, unstable chest pain, or stroke in the last 6 months.I am fully active or can carry out light work.I haven't taken any experimental drugs recently.I cannot take medications by mouth.You have a fever or active infection that the doctor thinks could make it hard for you to take part in the trial or affect the study results.My blood clotting time is normal or near normal, or controlled if I'm on blood thinners.My kidney function is within the normal range.My cancer is advanced, cannot be surgically removed, and can be measured by specific criteria.I need a new biopsy for my condition before joining the study.I have tried at least one standard treatment for my advanced cancer but it didn't work or I couldn't tolerate it.I have pancreatic cancer that cannot be surgically removed or has spread, and I haven't been treated with irinotecan.I am allergic to nal-IRI, liposomal products, fluoropyrimidines, or leucovorin.My cancer can be measured and has grown despite previous radiation.I am using or willing to use birth control or practice abstinence.My white blood cell count is healthy without needing medication to boost it.My hemoglobin level is at least 8 g/dL, or I've had a transfusion to reach this.I am not pregnant or breastfeeding, and if capable of having children, I agree to use birth control during and for 3 months after the study.I have stable brain metastases, not on steroids for 7 days, and no carcinomatous meningitis.I have a specific genetic makeup (UGT1A1*28) relevant for the study.I have been treated before for my advanced or spreading cancer.My kidney function is within the required range for the study.My liver function tests are within the required limits.My bilirubin levels are within the normal range.My blood clotting time is normal or managed with medication.I am a man who can father children and agree to use birth control or practice abstinence.I have advanced gastrointestinal cancer and previous treatments didn't work.I have previously been treated with irinotecan.You have been diagnosed with HIV.I have recovered from my last cancer treatment.I have a history of DPD deficiency.I can understand and sign the consent form myself, or have someone who can do it for me.I have colorectal cancer, it has spread, and I haven't had irinotecan treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (Nal-IRI, TAS-102)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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