Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies
NCT ID: NCT01607957
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
800 participants
INTERVENTIONAL
2012-06-17
2016-05-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TAS-102
TAS-102
35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met.
Placebo
Placebo
Placebo tablets, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met.
Interventions
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TAS-102
35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met.
Placebo
Placebo tablets, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met.
Eligibility Criteria
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Inclusion Criteria
2. Has adenocarcinoma of the colon or rectum
3. Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer
4. ECOG performance status of 0 or 1
5. Is able to take medications orally
6. Has adequate organ function (bone marrow, kidney and liver)
7. Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.
Exclusion Criteria
2. Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, within the specified time frames prior to study drug administration
3. Has received TAS-102
4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
5. Is a pregnant or lactating female
18 Years
ALL
No
Sponsors
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Taiho Oncology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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From - Boston, MA
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
From - Leuven, Belgium
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Gasthuisberg
From - Kashiwa, Chiba Japan
Role: PRINCIPAL_INVESTIGATOR
National Cancer Center Hospital East
Locations
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Arizona Center for Cancer Care
Glendale, Arizona, United States
California Cancer Associates for Research and Excellence
Fresno, California, United States
Ronald H. Yanagihara, MD
Gilroy, California, United States
LAC and USC Medical Center
Los Angeles, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Pacific Hematology Oncology Associates
San Francisco, California, United States
San Jose Medical Group
San Jose, California, United States
Coastal Integrative Cancer Care
San Luis Obispo, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
MD Anderson Cancer Center Orlando
Orlando, Florida, United States
Illinois Cancer Care, P.C.
Peoria, Illinois, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Ochsner Clinic Fndtn
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Jefferson City Medical Group
Jefferson City, Missouri, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Gabrail Cancer Center
Canton, Ohio, United States
Hickman Cancer Center at Flower Hospital
Sylvania, Ohio, United States
Hematology/Oncology Associates of Fredericksburg
Fredericksburg, Virginia, United States
Royal North Shore Hospital
Sydney, New South Wales, Australia
The Queen Elisabeth Hospital
Woodville South, South Australia, Australia
Austin Hospital
Heidelberg, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia
Krankenhaus der Barmherzigen Schwestern Linz
Linz, , Austria
Universitaet Wien
Vienna, , Austria
Universitaetsklinik fur Innere Medizin
Vienna, , Austria
Wilhelminenspital Wien
Vienna, , Austria
Klinikum Wels-Grieskirchen GmbH
Wels, , Austria
Cliniques Universitaires UCL St. Luc
Brussels, , Belgium
Erasme University Hospital-ULB-Brussels
Brussels, , Belgium
Grand Hospital de Charleroi
Charleroi, , Belgium
Antwerp University Hospital
Edegem, , Belgium
University Hospital Gent
Edegem, , Belgium
University Hospital Gent
Ghent, , Belgium
Leuven University Hospital - Campus Gasthuiseberg
Leuven, , Belgium
University Hospital Gasthuisberg
Leuven, , Belgium
Klinika onkologie a radioteraie, Facultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Institute of Oncology and Rehabilitation Ples
Nová Ves pod Pleší, , Czechia
CHU de Becançon
Besançon, , France
University Hospital of Bordeaux
Bordeaux, , France
Centre Oscar Lambret
Lille, , France
CRLC Val d'Aurelle
Montpellier, , France
Hopital Saint Antoine
Paris, , France
Centre Eugene Marquis
Rennes, , France
Onkologische Schwerpunktpraxis Kurfuerstendamm
Berlin, , Germany
Praxiskooperation Bonn-Euskirchen-Rheinbach
Bonn, , Germany
Uniklinik Koeln
Cologne, , Germany
Universitatsklinikum Carl Gustav Carus - Dresden
Dresden, , Germany
Medizinische Klinik am Krankenhaus Nordwest GmbH
Frankfurt, , Germany
Uniklinik der Martin-Luther-Universitaet Halle-Wittenberg
Halle, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Johannes Gutenberg Universität Mainz
Mainz, , Germany
Interdisziplinaeres Tumorzentrum Mannheim
Mannheim, , Germany
Klinikum der Universität München - Großhadern
München, , Germany
Staedtisches Klinikum Muenchen / Klinikum Neuperlach
München, , Germany
Klinikum Oldenburg gGmbH
Oldenburg, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
Bon Secours Hospital
Cork, , Ireland
Adelaide and Meath Hospital
Dublin, , Ireland
St. Vincent's University Hospital
Dublin, , Ireland
Fondazione Poliambulanza
Brescia, Lombardy, Italy
Universita Delgi Studi de Genova (UNIGE)- Azienda Ospedaliera. Universitaria "San Martino" (Ospedale San Martino)
Genova, , Italy
A.O. Ospedale Niguarda Ca' Granda
Milan, , Italy
Fondazione IRCCS Instituto Nazionale dei Tumori Milano
Milan, , Italy
A.O. R.N. "A.Cardarelli"
Naples, , Italy
Seconda Universita degli Studi de Napoli
Napoli, , Italy
AOU San Luidi di Orbassano
Orbassano, , Italy
Azienda Ospedaliero
Pisa, , Italy
Arcispidale S Maria Nuova
Reggio Emilia, , Italy
Ospedale di Rimini
Rimini, , Italy
Ospedale di Sondrio
Sondrio, , Italy
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
KKR Sapporo Medical Center TONAN-Hospital
Sapporo, Hokkaido, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Tsukuba University Hospital
Tsukuba, Ibaraki, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Osaka Medical College Hospital
Takatsuki, Osaka, Japan
Saitama Cancer Center
Kita-adachi-gun, Saitama, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, Japan
Chiba Cancer Center
Chiba, , Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
Kumamoto University Hospital
Kumamoto, , Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, , Japan
Tokushima University Hospital
Tokushima, , Japan
Hospital Universitario Vall d'Hebrón
Barcelona, , Spain
Hospital Arnau de Vilanova
Lleida, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Fundacion Jimenez Diaz - Universidad Autonoma de Madrid
Madrid, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Hospital Carlos Haya
Málaga, , Spain
Hospital Universitario Morales Messeguer
Murcia, , Spain
Corporacion Sanitaria Parc Tauli
Sabadell, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Karolinska University Hospital
Stockholm, , Sweden
Akademiska Sjukhuset
Uppsala, , Sweden
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, , United Kingdom
St James' Institute of Oncology
Leeds, , United Kingdom
University College London Hospitals Foundation NHS Trust
London, , United Kingdom
The Royal Marsden NHS Foundation Trust
Surrey, , United Kingdom
Countries
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References
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Yoshino T, Cleary JM, Van Cutsem E, Mayer RJ, Ohtsu A, Shinozaki E, Falcone A, Yamazaki K, Nishina T, Garcia-Carbonero R, Komatsu Y, Baba H, Argiles G, Tsuji A, Sobrero A, Yamaguchi K, Peeters M, Muro K, Zaniboni A, Sugimoto N, Shimada Y, Tsuji Y, Hochster HS, Moriwaki T, Tran B, Esaki T, Hamada C, Tanase T, Benedetti F, Makris L, Yamashita F, Lenz HJ. Neutropenia and survival outcomes in metastatic colorectal cancer patients treated with trifluridine/tipiracil in the RECOURSE and J003 trials. Ann Oncol. 2020 Jan;31(1):88-95. doi: 10.1016/j.annonc.2019.10.005.
Van Cutsem E, Mayer RJ, Laurent S, Winkler R, Gravalos C, Benavides M, Longo-Munoz F, Portales F, Ciardiello F, Siena S, Yamaguchi K, Muro K, Denda T, Tsuji Y, Makris L, Loehrer P, Lenz HJ, Ohtsu A; RECOURSE Study Group. The subgroups of the phase III RECOURSE trial of trifluridine/tipiracil (TAS-102) versus placebo with best supportive care in patients with metastatic colorectal cancer. Eur J Cancer. 2018 Feb;90:63-72. doi: 10.1016/j.ejca.2017.10.009. Epub 2017 Dec 21.
Longo-Munoz F, Argiles G, Tabernero J, Cervantes A, Gravalos C, Pericay C, Gil-Calle S, Mizuguchi H, Carrato-Mena A, Limon ML, Garcia-Carbonero R. Efficacy of trifluridine and tipiracil (TAS-102) versus placebo, with supportive care, in a randomized, controlled trial of patients with metastatic colorectal cancer from Spain: results of a subgroup analysis of the phase 3 RECOURSE trial. Clin Transl Oncol. 2017 Feb;19(2):227-235. doi: 10.1007/s12094-016-1528-7. Epub 2016 Jul 21.
Mayer RJ, Van Cutsem E, Falcone A, Yoshino T, Garcia-Carbonero R, Mizunuma N, Yamazaki K, Shimada Y, Tabernero J, Komatsu Y, Sobrero A, Boucher E, Peeters M, Tran B, Lenz HJ, Zaniboni A, Hochster H, Cleary JM, Prenen H, Benedetti F, Mizuguchi H, Makris L, Ito M, Ohtsu A; RECOURSE Study Group. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015 May 14;372(20):1909-19. doi: 10.1056/NEJMoa1414325.
Other Identifiers
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2012-000109-66
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TPU-TAS-102-301
Identifier Type: -
Identifier Source: org_study_id
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