Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies
- Registration Number
- NCT01607957
- Lead Sponsor
- Taiho Oncology, Inc.
- Brief Summary
The purpose of this study is to compare the efficacy and safety of TAS-102 versus placebo in patients with refractory metastatic colorectal cancer.
- Detailed Description
This is a multinational, double-blind, two-arm, parallel, randomized Phase 3 comparison study evaluating the efficacy and safety of TAS-102 versus placebo in patients with refractory metastatic colorectal cancer. Patients will be randomly assigned (2:1) to TAS-102 (experimental arm) or placebo (control arm).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 800
- Has provided written informed consent
- Has adenocarcinoma of the colon or rectum
- Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer
- ECOG performance status of 0 or 1
- Is able to take medications orally
- Has adequate organ function (bone marrow, kidney and liver)
- 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.
- Certain serious illnesses or medical condition(s)
- 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
- Has received TAS-102
- Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
- Is a pregnant or lactating female
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - TAS-102 TAS-102 -
- Primary Outcome Measures
Name Time Method Overall Survival Every 8 weeks, up to 12 months after the last participant was randomized or until the target number of events (deaths) was met, whichever was later. (Overall survival data was collected till 24 Jan 2014 which was date of observation of the 571st death) Overall survival was defined as the time from the date of randomization to the date of death for participants. If a participant discontinued study medication for reasons other than radiologic disease progression, the participant was followed for tumor response until radiologic disease progression or initiation of new anticancer therapy.
- Secondary Outcome Measures
Name Time Method Progression-free Survival Every 8 weeks, up to 12 months after the last participant was randomized or until the date of the investigator-assessed radiological disease progression or death due to any cause,whichever was later. (Progression free survival cutoff: 31 Jan 2014) Tumor assessments were performed throughout the study based on RECIST, Version 1.1, 2009. Progression free survival was defined as the time (in months) from the date of randomization until the date of the investigator-assessed radiological disease progression or death due to any cause. For participants who were alive with no radiological disease progression as of the analysis cut-off date, their survival was censored at the date of the last tumor assessment. Participants who received non-study cancer treatment before disease progression, or participants with clinical but not radiologic evidence of progression, were censored at the date of the last radiologic evaluable tumor assessment before the non-study cancer treatment was initiated.
Percentage of Participants With Adverse Events (AE), Treatment-Related AEs, Discontinuations, Serious Adverse Events (SAEs) and Deaths From the time of signing the informed consent form until the period of participant follow up (30 days following after the administration of last dose of study medication or until initiation of new antitumor therapy, whichever was earlier An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AEs were events between administration of study drug and up to 30 Days that were absent before treatment or that worsened relative to pre-treatment state. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability /incapacity; congenital anomaly. The AEs were graded for severity using National Cancer Institute Common Terminology Criteria for AEs.
Trial Locations
- Locations (113)
San Jose Medical Group
🇺🇸San Jose, California, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Jefferson City Medical Group
🇺🇸Jefferson City, Missouri, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
CRLC Val d'Aurelle
🇫🇷Montpellier, France
Centre Eugene Marquis
🇫🇷Rennes cedex, France
Klinikum der Universität München - Großhadern
🇩🇪München, Germany
Klinikum Oldenburg gGmbH
🇩🇪Oldenburg, Germany
Sir Charles Gairdner Hospital
🇦🇺Perth, Western Australia, Australia
Chiba Cancer Center
🇯🇵Chiba, Japan
Pacific Hematology Oncology Associates
🇺🇸San Francisco, California, United States
Indiana University Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Klinikum Wels-Grieskirchen GmbH
🇦🇹Wels, Austria
Universitaet Wien
🇦🇹Wien, Austria
Universitaetsklinik fur Innere Medizin
🇦🇹Wien, Austria
Shizuoka Cancer Center
🇯🇵Sunto-gun, Shizuoka, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
🇯🇵Osaka, Japan
Jichi Medical University Hospital
🇯🇵Shimotsuke, Tochigi, Japan
Austin Hospital
🇦🇺Heidelberg, Victoria, Australia
The Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Krankenhaus der Barmherzigen Schwestern Linz
🇦🇹Linz, Austria
Antwerp University Hospital
🇧🇪Edegem, Belgium
University Hospital Gent
🇧🇪Gent, Belgium
Leuven University Hospital - Campus Gasthuiseberg
🇧🇪Leuven, Belgium
National Hospital Organization Shikoku Cancer Center
🇯🇵Matsuyama, Ehime, Japan
Tokushima University Hospital
🇯🇵Tokushima, Japan
Wilhelminenspital Wien
🇦🇹Wien, Austria
Erasme University Hospital-ULB-Brussels
🇧🇪Brussels, Belgium
Grand Hospital de Charleroi
🇧🇪Charleroi, Belgium
Fondazione Poliambulanza
🇮🇹Brescia, Lombardy, Italy
Osaka Medical College Hospital
🇯🇵Takatsuki, Osaka, Japan
Kanagawa Cancer Center
🇯🇵Yokohama, Kanagawa, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo, Japan
Saitama Cancer Center
🇯🇵Kita-adachi-gun, Saitama, Japan
National Hospital Organization Kyushu Cancer Center
🇯🇵Fukuoka, Japan
Kumamoto University Hospital
🇯🇵Kumamoto, Japan
Ospedale di Rimini
🇮🇹Rimini, Italy
Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
Hospital ClÃnico Universitario de Valencia
🇪🇸Valencia, Spain
Arizona Center for Cancer Care
🇺🇸Glendale, Arizona, United States
Ronald H. Yanagihara, MD
🇺🇸Gilroy, California, United States
California Cancer Associates for Research and Excellence
🇺🇸Fresno, California, United States
LAC and USC Medical Center
🇺🇸Los Angeles, California, United States
USC Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Coastal Integrative Cancer Care
🇺🇸San Luis Obispo, California, United States
Illinois Cancer Care, P.C.
🇺🇸Peoria, Illinois, United States
Mary Bird Perkins Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Hematology/Oncology Associates of Fredericksburg
🇺🇸Fredericksburg, Virginia, United States
Hickman Cancer Center at Flower Hospital
🇺🇸Sylvania, Ohio, United States
Royal North Shore Hospital
🇦🇺Sydney, New South Wales, Australia
The Queen Elisabeth Hospital
🇦🇺Woodville South, South Australia, Australia
Cliniques Universitaires UCL St. Luc
🇧🇪Brussels, Belgium
University Hospital Gasthuisberg
🇧🇪Leuven, Belgium
CHU de Becançon
🇫🇷Besancon, France
University Hospital of Bordeaux
🇫🇷Bordeaux, France
Klinika onkologie a radioteraie, Facultni nemocnice Hradec Kralove
🇨🇿Hradec Kralove, Czechia
Institute of Oncology and Rehabilitation Ples
🇨🇿Nova Ves pod Plesi, Czechia
Centre Oscar Lambret
🇫🇷Lille, France
Onkologische Schwerpunktpraxis Kurfuerstendamm
🇩🇪Berlin, Germany
Hopital Saint Antoine
🇫🇷Paris cedex 12, France
Praxiskooperation Bonn-Euskirchen-Rheinbach
🇩🇪Bonn, Germany
Universitatsklinikum Carl Gustav Carus - Dresden
🇩🇪Dresden, Germany
Medizinische Klinik am Krankenhaus Nordwest GmbH
🇩🇪Frankfurt, Germany
Uniklinik der Martin-Luther-Universitaet Halle-Wittenberg
🇩🇪Halle (Saale), Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Uniklinik Koeln
🇩🇪Koeln, Germany
Johannes Gutenberg Universität Mainz
🇩🇪Mainz, Germany
Interdisziplinaeres Tumorzentrum Mannheim
🇩🇪Mannheim, Germany
Staedtisches Klinikum Muenchen / Klinikum Neuperlach
🇩🇪Muenchen, Germany
Bon Secours Hospital
🇮🇪Cork, Ireland
Adelaide and Meath Hospital
🇮🇪Dublin, Ireland
St. Vincent's University Hospital
🇮🇪Dublin, Ireland
Universita Delgi Studi de Genova (UNIGE)- Azienda Ospedaliera. Universitaria "San Martino" (Ospedale San Martino)
🇮🇹Genova, Italy
Fondazione IRCCS Instituto Nazionale dei Tumori Milano
🇮🇹Milano, Italy
Seconda Universita degli Studi de Napoli
🇮🇹Napoli, Italy
A.O. Ospedale Niguarda Ca' Granda
🇮🇹Milan, Italy
A.O. R.N. "A.Cardarelli"
🇮🇹Naples, Italy
AOU San Luidi di Orbassano
🇮🇹Orbassano, Italy
Azienda Ospedaliero
🇮🇹Pisa, Italy
Arcispidale S Maria Nuova
🇮🇹Reggio Emilia, Italy
Ospedale di Sondrio
🇮🇹Sondrio, Italy
Aichi Cancer Center Hospital
🇯🇵Nagoya, Aichi, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa, Chiba, Japan
KKR Sapporo Medical Center TONAN-Hospital
🇯🇵Sapporo, Hokkaido, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital
🇯🇵Kobe, Hyogo, Japan
Tsukuba University Hospital
🇯🇵Tsukuba, Ibaraki, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
🇯🇵Koto-ku, Tokyo, Japan
Keio University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Hospital Universitario Vall d'Hebrón
🇪🇸Barcelona, Spain
Hospital Arnau de Vilanova
🇪🇸Lleida, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Carlos Haya
🇪🇸Malaga, Spain
Fundacion Jimenez Diaz - Universidad Autonoma de Madrid
🇪🇸Madrid, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario Morales Messeguer
🇪🇸Murcia, Spain
Corporacion Sanitaria Parc Tauli
🇪🇸Sabadell, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Akademiska Sjukhuset
🇸🇪Uppsala, Sweden
Karolinska University Hospital
🇸🇪Stockholm, Sweden
Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
University Hospitals Bristol NHS Foundation Trust
🇬🇧Bristol, United Kingdom
The Royal Marsden NHS Foundation Trust
🇬🇧Surrey, United Kingdom
University College London Hospitals Foundation NHS Trust
🇬🇧London, United Kingdom
St James' Institute of Oncology
🇬🇧Leeds, United Kingdom
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
MD Anderson Cancer Center Orlando
🇺🇸Orlando, Florida, United States
St. Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
Saint Luke's Cancer Institute
🇺🇸Kansas City, Missouri, United States
Ochsner Clinic Fndtn
🇺🇸New Orleans, Louisiana, United States