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Anti-metabolites

Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102 for Bile Duct Cancer

Phase 2

Waitlist Available

Led By Amit Mahipal

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial tests how well trifluridine/tipiracil hydrochloride combination agent TAS-102 works in treating biliary tract cancers that have spread to other places in the body.

Eligible Conditions

Bile Duct Cancer
Gallbladder Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

16-Week Progression-free Survival (PFS) Rate

Secondary outcome measures

Overall Response Rate (ORR)

Overall Survival (OS)

Overall Toxicity Rates (Percentages) for Grade 3 or Higher Adverse Events Considered at Least Possibly Related to Treatment, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4)

+1 more

Other outcome measures

Change in Circulating Tumor Cells (CTCs) or Cell-free Deoxyribonucleic Acid (DNA) (cfDNA)

Circulating Tumor Cells (CTCs) or Cell-free Deoxyribonucleic Acid (DNA) (cfDNA) Analysis at Baseline

Mutation Status of the Tumor

Side effects data

From 2021 Phase 2 trial • 28 Patients • NCT03278106

100%

Fatigue

93%

Anemia

81%

Abdominal pain

74%

Anorexia

63%

Nausea

59%

Platelet count decreased

56%

Neutrophil count decreased

44%

White blood cell decreased

44%

Diarrhea

33%

Vomiting

22%

Alkaline phosphatase increased

19%

General disorders and administration site conditions - Other, specify

19%

Constipation

15%

Aspartate aminotransferase increased

15%

Back pain

15%

Blood bilirubin increased

11%

Peripheral sensory neuropathy

11%

Lymphocyte count decreased

11%

Edema limbs

Hepatobiliary disorders - Other, specify

Alanine aminotransferase increased

Arthralgia

Generalized muscle weakness

Dyspnea

Alopecia

Hypertension

Infections and infestations - Other, specify

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Mucositis oral

Confusion

Pain in extremity

Headache

Neck edema

Sinus tachycardia

Insomnia

Fever

Tumor pain

Hypoalbuminemia

Pruritus

Skin and subcutaneous tissue disorders - Other, specify

Cognitive disturbance

Biliary tract infection

Hepatic infection

Watering eyes

Ascites

Oral pain

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (TAS-102)

Trial Design

1Treatment groups

Experimental Treatment

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

Patients receive trifluridine/tipiracil hydrochloride combination agent TAS-102 orally PO BID on days 1-5 and 8-12. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tipiracil

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,212 Previous Clinical Trials

3,767,010 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,826 Total Patients Enrolled

Amit MahipalPrincipal InvestigatorMayo Clinic

1 Previous Clinical Trials

28 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102 been studied before in any previous investigations?

"At this moment in time, there are 43 active clinical research projects focusing on Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102 with 4 of them at the Phase 3 stage. As many as 527 trial sites throughout the world have opened their doors to studying this medication; a notable number can be found in Lakewood, New jersey."

Answered by AI

What have been the findings of safety studies involving Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102?

"TAS-102 was appraised to be safe at a level of 2, reflecting the Phase 2 status which indicates that there is some data confirming safety but none indicating efficacy."

Answered by AI

What primary purpose does Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102 serve?

"Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102 is oftentimes prescribed to treat vaccinia related corneal and conjunctival infections. Additionally, this medication can be applied when dealing with conditions like oxaliplatin chemotherapy resistance, anti-VEGF treatment failure, as well as blepharitis."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TAS-102 in Treating Advanced Biliary Tract Cancers

2017. "TAS-102 in Treating Advanced Biliary Tract Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03278106.