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Clinical trials for Trifluridine

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    32 result(s) found for: Trifluridine. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2021-003151-41 Sponsor Protocol Number: CL3-95026-001 Start Date*: 2022-01-25
    Sponsor Name:Institut de Recherches Internationales Servier
    Full Title: A randomised, open-label, multi-centre, two-arm Phase 3 study comparing futuximab/modotuximab in combination with trifluridine/tipiracil to trifluridine/tipiracil single agent with a Safety Lead-In...
    Medical condition: Metastatic colorectal cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052358 Colorectal cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended) BE (Completed) FI (Completed) HU (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2020-001976-14 Sponsor Protocol Number: CL3-95005-007 Start Date*: 2020-09-22
    Sponsor Name:Institut de Recherches Internationales Servier
    Full Title: An open-label, randomised, phase III study comparing trifluridine/tipiracil in combination with bevacizumab to trifluridine/tipiracil monotherapy in patients with refractory metastatic colorectal c...
    Medical condition: Refractory metastatic colorectal cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052358 Colorectal cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) FR (Completed) DE (Completed) HU (Completed) BE (Completed) AT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-003799-15 Sponsor Protocol Number: ACE1100-01 Start Date*: 2022-04-25
    Sponsor Name:Ascelia Pharma AB
    Full Title: A Randomized, Double-blind Study to Investigate the Safety, Pharmacokinetics, and Antitumor Activity of ASC-201 Plus Trifluridine/Tipiracil Compared With Trifluridine/Tipiracil in Patients With Adv...
    Medical condition: Advanced Gastric Cancer.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10017947 Gastrointestinal disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-001600-12 Sponsor Protocol Number: 20177097 Start Date*: 2019-05-29
    Sponsor Name:Dipartimento di Medicina di Precisione - Università degli studi della Campania "L. Vanvitelli"
    Full Title: 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
    Medical condition: mCRC
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10017991 Gastrointestinal neoplasms malignant and unspecified HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-004223-20 Sponsor Protocol Number: FIRE-8 Start Date*: 2021-06-15
    Sponsor Name:Charité Universitätsmedizin Berlin
    Full Title: Prospective, randomized, open, multicenter Phase II trial to investigate the efficacy of trifluridine/tipiracil plus panitumumab versus trifluridine/tipiracil plus bevacizumab as first-line treatme...
    Medical condition: Prospective, randomized, open, multicenter Phase II trial to investigate the efficacy of trifluridine/tipiracil plus panitumumab versus trifluridine/tipiracil plus bevacizumab as first-line treatme...
    Disease: Version SOC Term Classification Code Term Level
    27.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052362 Metastatic colorectal cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-002311-18 Sponsor Protocol Number: CL3-95005-004 Start Date*: 2016-09-19
    Sponsor Name:Laboratorios Servier S. L.
    Full Title: An open-label early access phase IIIb study of trifluridine / tipiracil (S 95005/TAS-102) in patients with a pretreated metastatic colorectal cancer.
    Medical condition: Metastatic colorectal cancer
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052358 Colorectal cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) BE (Completed) PT (Completed) PL (Completed) SI (Completed) FR (Completed) SK (Completed) BG (Completed) HR (Completed) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2021-004008-16 Sponsor Protocol Number: 20190172 Start Date*: 2022-01-26
    Sponsor Name:Amgen, Inc.
    Full Title: A Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib and Panitumumab Versus Investigator’s Choice (Trifluridine and Tipiracil, or Regorafenib) for the Treatment of Pr...
    Medical condition: Previously Treated Metastatic Colorectal Cancer Subjects with KRAS p.G12C Mutation
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10052362 Metastatic colorectal cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Restarted) GR (Trial now transitioned) ES (Ongoing) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-004059-22 Sponsor Protocol Number: CL3-95005-006 Start Date*: 2018-06-01
    Sponsor Name:Institut de Recherches Internationales Servier
    Full Title: An open-label, randomised, phase III Study cOmparing trifLuridine/tipiracil (S 95005) in combination with bevacizumab to capecitabine in combination with bevacizumab in firST-line treatment of pati...
    Medical condition: Metastatic colorectal cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052358 Colorectal cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IE (Completed) SE (Trial now transitioned) AT (Completed) ES (Ongoing) DK (Trial now transitioned) LT (Completed) NL (Completed) LV (Completed) SK (Trial now transitioned) CZ (Completed) HU (Completed) DE (Completed) PL (Trial now transitioned) PT (Completed) BG (Completed) IT (Completed) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2021-004285-35 Sponsor Protocol Number: CA224-123 Start Date*: 2022-07-12
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3, Randomized, Open-label (Sponsor Blinded) Study of Relatlimab-nivolumab Fixed-dose Combination Versus Regorafenib or Trifluridine + Tipiracil (TAS-102) for Participants with Later-lines o...
    Medical condition: Metastatic Colorectal Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052362 Metastatic colorectal cancer LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052358 Colorectal cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) AT (Trial now transitioned) ES (Ongoing) DE (Trial now transitioned) IT (Trial now transitioned) PL (Trial now transitioned) NL (Trial now transitioned) CZ (Trial now transitioned) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-000627-13 Sponsor Protocol Number: C201 Start Date*: 2018-06-06
    Sponsor Name:GAMAMABS Pharma
    Full Title: OPEN, NON CONTROLLED, PARALLEL COHORTS, MULTICENTER, PHASE 2A STUDY FOR THE EVALUATION OF THE ANTITUMOR ACTIVITY OF GM102 SINGLE AGENT AND IN COMBINATION WITH CHEMOTHERAPY IN PATIENTS WITH LOCALLY ...
    Medical condition: Patients with locally advanced or metastatic colorectal cancer (CRC), having received at least two lines of therapy for the locally advanced or metastatic CRC disease.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10010030 Colorectal cancer recurrent PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10010034 Colorectal cancer stage III PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10010035 Colorectal cancer stage IV PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052358 Colorectal cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2020-000923-37 Sponsor Protocol Number: TriComB Start Date*: 2021-08-04
    Sponsor Name:G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST
    Full Title: A phase 1/2 study exploring the safety and activity of Trifluridine/tipiracil in combination with capecitabine and bevacizumab in metastatic colorectal cancer patients.
    Medical condition: metastatic colorectal cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10052362 Metastatic colorectal cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004196-39 Sponsor Protocol Number: UC-GIG-1910 Start Date*: 2020-07-23
    Sponsor Name:UNICANCER
    Full Title: A randomized, phase II study comparing the sequences of regorafenib and trifluridine/tipiracil, after failure of standard therapies in patients with metastatic colorectal cancer
    Medical condition: The study population will consist of male and female patients aged ≥ 18 years old with metastatic colorectal cancer after failure of fluoropyrimidine-, irinotecan-, and oxaliplatin-based chemothera...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10079136 Adenocarcinoma of colon metastatic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) BE (Completed) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-004845-18 Sponsor Protocol Number: 1.4 Start Date*: 2019-03-27
    Sponsor Name:Lene Bæksgaard Jensen
    Full Title: LON-GAS TRIFLURIDINE/TIPIRACIL (FTD/TPI) with or without Bevacizumab in patients with platinum-refractory esophago-gastric adenocarcinoma. A randomized phase III study
    Medical condition: TRIFLURIDINE/TIPIRACIL (FTD/TPI) with or without bevacizumab in patients with platinum-refractory esophago-gastric adenocarcinoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2017-000292-83 Sponsor Protocol Number: Tallisur Start Date*: 2017-08-30
    Sponsor Name:Servier Deutschland GmbH
    Full Title: Prospective, Multicenter, Open-label Phase IV trial of Trifluridine/Tipiracil to Evaluate the Health-related Quality of Life in Patients with Metastatic Colorectal Cancer
    Medical condition: Histologically or cytologically confirmed UICC stage IV carcinoma of colon or rectum with metastasis (metastatic colorectal cancer) with need for treatment due to progression
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-004636-25 Sponsor Protocol Number: ACOTAS_G098 Start Date*: 2021-06-17
    Sponsor Name:GERCOR
    Full Title: A phase II study to evaluate the rate of cardiovascular events during trifluridine/tipiracil +/-oxaliplatin treatment in colorectal/oesogastric adenocarcinoma patients that have experienced a pas...
    Medical condition: colorectal or oesogastric adenocarcinoma
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052360 Colorectal adenocarcinoma PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10017758 Gastric cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-000109-66 Sponsor Protocol Number: TPU-TAS-102-301 Start Date*: 2012-12-10
    Sponsor Name:Taiho Oncology, Inc.
    Full Title: RANDOMIZED, DOUBLE-BLIND, PHASE 3 STUDY OF TAS-102 PLUS BEST SUPPORTIVE CARE (BSC) VERSUS PLACEBO PLUS BSC IN PATIENTS WITH METASTATIC COLORECTAL CANCER REFRACTORY TO STANDARD CHEMOTHERAPIES
    Medical condition: Refractory metastatic colorectal cancer
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052358 Colorectal cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) SE (Completed) AT (Completed) ES (Completed) IE (Completed) CZ (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2022-000273-81 Sponsor Protocol Number: UC-GIG-2203 Start Date*: 2022-09-13
    Sponsor Name:UNICANCER
    Full Title: Randomised phase II study evaluating trifluridine/tipiracil plus oxaliplatin versus FOLFOX in patients with gastric, oesophagus or gastroesophageal junction adenocarcinoma locally advanced, recurre...
    Medical condition: Patients with gastric, oesophagus or gastroesophageal junction adenocarcinoma locally advanced, recurrent or metastatic, ineligible for triplet chemotherapy.
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10030137 Oesophageal adenocarcinoma PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10001150 Adenocarcinoma gastric PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066354 Adenocarcinoma of the gastroesophageal junction LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-004544-18 Sponsor Protocol Number: CL2-95005-002 Start Date*: 2016-03-23
    Sponsor Name:Institut de Recherches Internationales Servier
    Full Title: An open-label, randomised, non-comparative phase 2 study evaluating S 95005 (TAS-102) plus bevacizumab and capecitabine plus bevacizumab in patients with previously untreated metastatic COlorectal ...
    Medical condition: Metastatic colorectal cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052358 Colorectal cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) DK (Completed) NL (Completed) BE (Completed) ES (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-000276-41 Sponsor Protocol Number: SUMO Start Date*: 2020-03-05
    Sponsor Name:Erasmus MC
    Full Title: Study on the effects of an OCT2/MATE1 substrate (metformin) and inhibitor (cimetidine) on the exposure of trifluridine/tipiracil (Lonsurf®) in patients with metastatic colorectal cancer (mCRC).
    Medical condition: patients with mCRC with an indication for lonsurf treatment.
    Disease:
    Population Age: Gender:
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-002936-26 Sponsor Protocol Number: 17-157 Start Date*: 2019-11-28
    Sponsor Name:Heinrich-Heine-University Düsseldorf
    Full Title: Efficacy and safety of Trifluridine/Tipiracil in combination with Irinotecan as a second line therapy in patients with Cholangiocarcinoma
    Medical condition: Patients with advanced, non resectable or metastatic cholangio- and gallbladder carcinoma after failure to respond to a previous gemcitabine treatment.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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