Trifluridine

Generic Name: Trifluridine

Brand Names: Lonsurf, Viroptic

Drug Type: Small Molecule

Chemical Formula: C_₁₀H_₁₁F_₃N_₂O_₅

CAS Number: 70-00-8

Unique Ingredient Identifier: RMW9V5RW38

Background: Trifluridine is a fluorinated pyrimidine nucleoside that is structurally related to idoxuridine . It is an active antiviral agent in ophthalmic solutions used mainly in the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus. It displays effective antiviral activity against Herpes simplex virus type 1 and 2 .

The combination product of trifluridine with tipiracil marketed as Lonsurf has been approved in Japan, the United States, and the European Union for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. In the anticancer therapy, trifluridine acts as a thymidine-based nucleoside metabolic inhibitor that gets incorporated into DNA of cancer cells following cell uptake to aberrate DNA function during cell replication .

Indication: 用于Ⅰ及Ⅱ型单纯疱疹病毒、胞病毒、牛痘病毒、巨细胞病毒、带状疱疹病毒及耐阿昔洛韦的疱疹病毒的眼部感染。

Associated Conditions: Metastatic Colorectal Cancer (CRC), Metastatic Gastric Cancers, Metastatic Gastroesophageal Junction Adenocarcinoma, Primary keratoconjunctivitis caused by herpes simplex virus type 2, Recurrent epithelial keratitis caused by herpes simplex 2

Clinical Trials

Investigate the Efficacy of Chemotherapy in Patients With Positive ctDNA After Surgery and Adjuvant Chemotherapy for a Stage III Colorectal Cancer

Phase 3

Not yet recruiting

Conditions: Colon or Upper Rectum Adenocarcinoma

Interventions: Drug: "FOLFIRI" cures
Drug: Trifluridine cures
Biological: BIOLOGICAL ASSESSMENT
Other: Questionnaires
Other: Thoracic-abdomino-pelvic scan or MRI

First Posted Date: 2024-01-09

Last Posted Date: 2024-01-09

Lead Sponsor: Centre Hospitalier Universitaire Dijon

Target Recruit Count: 1660

Registration Number: NCT06197425

Locations: 🇫🇷
Chu Dijon Bourgogne, Dijon, France

Phase II Randomized Study Evaluating the Efficacy of Panitumumab (VEctibix ) and Trifluridine-Tipiracil (LOnsurf) in Pretreated RAS Wild Type Metastatic Colorectal Cancer Patients: the VELO Trial

Phase 2

Completed

Conditions: Metastatic Colon Cancer

Interventions: Drug: Trifluridine Tipiracil
Drug: Panitumumab 20 MG/1 ML Intravenous Solution [VECTIBIX]

First Posted Date: 2022-07-21

Last Posted Date: 2024-02-01

Lead Sponsor: University of Campania "Luigi Vanvitelli"

Target Recruit Count: 68

Registration Number: NCT05468892

Locations: 🇮🇹
A.O.U. Cagliari - Presidio Policlinico D. Casula, Monserrato, CA, Italy
🇮🇹
A.O.U. Pisana, Pisa, PI, Italy
🇮🇹
Universiyà Campus-Biomedico, Roma, Italy

and more 5 locations

Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation

Phase 3

Active, not recruiting

Conditions: Colorectal Cancer (CRC)

Interventions: Drug: Trifluridine and Tipiracil
Drug: Sotorasib
Drug: Panitumumab
Drug: Regorafenib

First Posted Date: 2022-01-20

Last Posted Date: 2025-04-15

Lead Sponsor: Amgen

Target Recruit Count: 160

Registration Number: NCT05198934

Locations: 🇯🇵
Saitama Cancer Center, Kitaadachi-gun, Saitama, Japan
🇺🇸
Kelsey Research Foundation, Houston, Texas, United States
🇺🇸
Northwest Georgia Oncology Centers PC, Marietta, Georgia, United States

and more 100 locations

A Study of ASP1570 Alone or in Combination With Pembrolizumab or Standard Therapies in Adults With Solid Tumors

Phase 1

Recruiting

Conditions: Advanced Solid Tumors

Interventions: Drug: ASP1570
Drug: Trifluridine + Tipiracil
Drug: pembrolizumab
Drug: Docetaxel
Drug: Bevacizumab

First Posted Date: 2021-10-19

Last Posted Date: 2025-04-23

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 310

Registration Number: NCT05083481

Locations: 🇪🇸
Site ES34002, Madrid, Spain
🇪🇸
Site ES34007, Malaga, Spain
🇪🇸
Site ES34006, Pozuelo de Alarcón, Spain

and more 23 locations

A Study to Evaluate the Safety and Efficacy of Selinexor With or Without Pembrolizumab Versus Standard of Care in Previously Treated Metastatic Colorectal Cancer With RAS Mutations

Phase 2

Terminated

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: Selinexor
Drug: Trifluridine
Drug: Tipiracil
Drug: Pembrolizumab

First Posted Date: 2021-04-22

Last Posted Date: 2023-11-03

Lead Sponsor: Karyopharm Therapeutics Inc

Target Recruit Count: 13

Registration Number: NCT04854434

Locations: 🇺🇸
Christiana Care Health Services, Christiana Hospital, Newark, Delaware, United States
🇺🇸
BRCR Global, Plantation, Florida, United States
🇺🇸
Valkyrie Clinical Trials, Los Angeles, California, United States

Initial Attack on Latent Metastasis Using TAS-102 for ct DNA Identified Colorectal Cancer Patients After Curative Resection

Phase 3

Recruiting

Conditions: Colorectal Neoplasms
Trifluridine and Tipiracil
Circulating Tumor DNA

Interventions: Drug: trifluridine and tipiracil
Drug: Placebo

First Posted Date: 2020-07-07

Last Posted Date: 2022-11-18

Lead Sponsor: National Cancer Center Hospital East

Target Recruit Count: 240

Registration Number: NCT04457297

Locations: 🇯🇵
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
🇯🇵
Sapporo Medical University Hospital, Sapporo, Hokkaido, Japan
🇯🇵
University of Tsukuba Hospital, Tsukuba, Ibaraki, Japan

and more 36 locations

Bioequivalence Study of Trifluridine and Tipiracil Tablets in Colorectal Cancer Patients

Phase 1

Completed

Conditions: Colorectal Cancer

Interventions: Drug: Trifluridine and Tipiracil Tablets
Drug: TAS-102

First Posted Date: 2019-06-05

Last Posted Date: 2022-04-19

Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Target Recruit Count: 64

Registration Number: NCT03974594

Locations: 🇨🇳
Tangdu Hospital,Fourth Military Medical University, Xi'an, Shanxi, China

Study Comparing the Pharmacokinetics of FTD as a Component of TAS-102 With FTD Alone

Phase 1

Completed

Conditions: Advanced Solid Tumors

Interventions: Drug: TAS-102
Drug: Trifluridine

First Posted Date: 2013-06-04

Last Posted Date: 2024-06-27

Lead Sponsor: Taiho Oncology, Inc.

Target Recruit Count: 44

Registration Number: NCT01867866

Locations: 🇺🇸
South Texas Accelerated Research Therapeutics, LLC, San Antonio, Texas, United States

Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine

Not Applicable

Completed

Conditions: Herpes Simplex
HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2021-11-02

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 25

Registration Number: NCT00000635

Locations: 🇺🇸
University of Colorado Hospital CRS, Aurora, Colorado, United States
🇺🇸
NY Univ. HIV/AIDS CRS, New York, New York, United States
🇺🇸
Cook County Hosp. CORE Ctr., Chicago, Illinois, United States

and more 5 locations

Evaluation of the Therapeutic Benefit of r-metHuIFN- Gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study

Not Applicable

Completed

Conditions: Mycobacterium Avium-Intracellulare Infection
HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2005-06-24

Lead Sponsor: Amgen

Target Recruit Count: 15

Registration Number: NCT00002037

Locations: 🇺🇸
New York Hosp - Cornell Med Ctr, New York, New York, United States

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