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Generated: December 18, 2018

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CLINICAL TRIALS PROFILE FOR TRIFLURIDINE

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Clinical Trials for Trifluridine

Trial ID Title Status Sponsor Phase Summary
NCT00000138 Herpetic Eye Disease Study (HEDS) I Unknown status National Eye Institute (NEI) Phase 3 To evaluate the efficacy of topical corticosteroids in treating herpes simplex stromal keratitis in conjunction with topical trifluridine. To evaluate the efficacy of oral acyclovir in treating herpes simplex stromal keratitis in patients receiving concomitant topical corticosteroids and trifluridine. To evaluate the efficacy of oral acyclovir in treating herpes simplex iridocyclitis in conjunction with treatment with topical corticosteroids and trifluridine.
NCT00000635 Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine Completed Glaxo Wellcome N/A To determine the safety, effectiveness, and toxicity of topical (local) trifluridine in treating mucocutaneous (at the nasal, oral, vaginal, and anal openings) Herpes simplex virus ( HSV ) disease that has shown resistance to acyclovir in HIV-infected patients. HSV infection in patients with AIDS is often associated with skin sores and frequent recurrences. Treatment with the drug acyclovir results in healing for most patients, but repeated treatment sometimes results in resistance of the virus to acyclovir. Thus, when this happens, other treatments need to be used. Trifluridine is an antiviral drug that is used for the treatment of Herpes infections that occur in the eye. This study attempts to determine if trifluridine is useful for treating HSV sores that have not healed after treatment with acyclovir.
NCT00000635 Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A To determine the safety, effectiveness, and toxicity of topical (local) trifluridine in treating mucocutaneous (at the nasal, oral, vaginal, and anal openings) Herpes simplex virus ( HSV ) disease that has shown resistance to acyclovir in HIV-infected patients. HSV infection in patients with AIDS is often associated with skin sores and frequent recurrences. Treatment with the drug acyclovir results in healing for most patients, but repeated treatment sometimes results in resistance of the virus to acyclovir. Thus, when this happens, other treatments need to be used. Trifluridine is an antiviral drug that is used for the treatment of Herpes infections that occur in the eye. This study attempts to determine if trifluridine is useful for treating HSV sores that have not healed after treatment with acyclovir.
NCT00081835 Evaluation and Treatment of Eye Complications of Vaccinia Vaccination Completed National Eye Institute (NEI) Phase 2 This study will evaluate patients with eye complications related to vaccination against smallpox to learn more about these conditions. Vaccinia vaccination has been used for more than 100 years for preventing smallpox. A small number of people who receive the vaccination (less than 1 in 1,000) develop complications, sometimes in their eyes. This usually results from the accidental transfer of the infection from the vaccination site to the face or eyes, perhaps by touching the vaccination area and then the face or eyelids before washing the hands. The study will also examine whether an experimental treatment called NP-016 vaccinia immune globulin can reduce corneal scarring that is sometimes associated with serious vaccinia complications and can impair vision. Children and adults with keratitis, severe conjunctivitis, or blepharitis following exposure to vaccinia vaccination may be eligible for this study. Children must weigh at least 10 kg. Participants undergo the following tests and procedures at enrollment, with some tests repeated at scheduled study visits: 1. Medical history and physical examination 2. Infectious disease consultation 3. Complete eye evaluation including: - Fundus photography to examine the back of the eye - dilation of the pupils with eye drops to examine and photograph the back of the eye - Slit lamp biomicroscopy - evaluation of the front part of the eye with a slit lamp microscope - Eye pressure measurements - Eye swab to look for vaccinia virus or other causes of disease 4. Blood tests 5. Photographs and documentation of eye and skin lesions 6. Vaccinia diagnostic tests, such as skin or mucosa scrapings; blood, throat, or urine cultures; and tissue biopsies, if needed Patients begin treatment with standard medications for their eye disease, such as trifluridine (Viroptic® (Registered Trademark)) anti-viral eye drops. Patients whose condition becomes serious are offered additional treatment with intravenous (through a vein) infusions of either VIG or placebo (salt water solution with no active drug) and are randomly assigned to one or the other treatment group. All patients continue standard-of-care treatment as well. Follow-up visits at the NIH eye clinic are scheduled as required by the patient's condition. Patients with mild complications who are taking only standard medications may need to be seen only 1 month after the initial visit and then 6 months and 12 months later. Patients with more serious conditions who qualify for VIG or placebo treatments may be seen daily for a week, then once a week for the rest of the first month, and then at 6 months and 12 months, unless more frequent treatment or observation is required.
NCT02654639 Ph 2 Study of TAS-102 / Bevacizumab Maintenance Therapy Post Induction Chemotherapy in Metastatic Colorectal Cancer Recruiting Georgetown University Phase 2 Phase II study of TAS-102 plus bevacizumab switch maintenance therapy in patients with mCRC
NCT03223779 Study of TAS-102 Plus Radiation Therapy for the Treatment of the Liver in Patients With Hepatic Metastases From Colorectal Cancer Not yet recruiting Taiho Oncology, Inc. Phase 1/Phase 2 This research study is studying a drug in combination with radiation therapy as a possible treatment for hepatic metastases from colorectal cancer. The interventions involved in this study are: - Trifluridine (TAS-102) - Radiation Therapy
NCT03223779 Study of TAS-102 Plus Radiation Therapy for the Treatment of the Liver in Patients With Hepatic Metastases From Colorectal Cancer Not yet recruiting Massachusetts General Hospital Phase 1/Phase 2 This research study is studying a drug in combination with radiation therapy as a possible treatment for hepatic metastases from colorectal cancer. The interventions involved in this study are: - Trifluridine (TAS-102) - Radiation Therapy
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Trifluridine

Condition Name

Condition Name for Trifluridine
Intervention Trials
Metastatic Colorectal Cancer 3
Stage IV Rectal Cancer AJCC v7 2
Stage IVA Rectal Cancer AJCC v7 2
Stage IVB Rectal Cancer AJCC v7 2
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Condition MeSH

Condition MeSH for Trifluridine
Intervention Trials
Colorectal Neoplasms 6
Herpes Simplex 2
Colonic Neoplasms 2
Rectal Neoplasms 2
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Clinical Trial Locations for Trifluridine

Trials by Country

Trials by Country for Trifluridine
Location Trials
United States 13
France 1
Poland 1
Slovakia 1
Turkey 1
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Trials by US State

Trials by US State for Trifluridine
Location Trials
Minnesota 2
Maryland 2
California 2
Arizona 1
Massachusetts 1
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Clinical Trial Progress for Trifluridine

Clinical Trial Phase

Clinical Trial Phase for Trifluridine
Clinical Trial Phase Trials
Phase 3 3
Phase 2 3
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Trifluridine
Clinical Trial Phase Trials
Not yet recruiting 6
Recruiting 3
Completed 2
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Clinical Trial Sponsors for Trifluridine

Sponsor Name

Sponsor Name for Trifluridine
Sponsor Trials
Mayo Clinic 2
National Eye Institute (NEI) 2
National Cancer Institute (NCI) 2
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Sponsor Type

Sponsor Type for Trifluridine
Sponsor Trials
Other 6
Industry 5
NIH 5
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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
UBS
McKesson
Colorcon
Fish and Richardson
Mallinckrodt
QuintilesIMS
Dow
Deloitte

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