Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer
- Conditions
- Refractory Metastatic Gastric Cancer
- Interventions
- Drug: Placebo
- Registration Number
- NCT02500043
- Lead Sponsor
- Taiho Oncology, Inc.
- Brief Summary
The purpose of this trial is to compare the effects of TAS-102 and best supportive care (BSC) with Placebo (an inactive drug) and best supportive care on metastatic gastric cancer.
- Detailed Description
This is a multinational, double-blind, two-arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of TAS-102 plus BSC versus placebo plus BSC in participants with metastatic gastric cancer who have previously received at least 2 prior regimens for advanced disease. Eligible participants will be centrally randomized (2:1) to TAS-102 + BSC (experimental arm) or placebo + BSC (control arm).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 507
- Has histologically confirmed non-resectable, metastatic gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction.
- Has previously received at least 2 prior regimens for advanced disease and were refractory to or unable to tolerate their last prior therapy.
- Has measureable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
- Is able to take medications orally (ie, no feeding tube).
- Has an Eastern Cooperative Oncology Group performance status of 0 or 1.
- Has adequate organ function as defined by protocol defined labs.
- 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.
- Has certain serious illnesses or medical conditions
- 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 previously received TAS-102.
- Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events 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+BSC Placebo Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met. TAS-102+BSC TAS-102 Participants received 35 milligrams per meter square (mg/m\^2) of TAS-102 tablets orally twice daily (BID) for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) From the date of randomization to the data cut-off date (maximum duration: up to approximately 46 months) OS was defined as the time from the date of randomization to the date of death due to any cause. Participants without documented death were censored at last follow-up or cut-off date, whichever comes first. OS was estimated by Kaplan-Meier method.
- Secondary Outcome Measures
Name Time Method Progression-Free Survival (PFS) From the date of randomization to the cut-off date (maximum duration: up to approximately 46 months) PFS was defined as the time from randomization until the date of first occurrence of investigator-assessed radiological disease progression or death due to any cause, whichever came first. Disease progression as per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) for target lesions were defined as target lesions with at least 20 % relative increase in the sum of diameters with reference to the smallest sum on study, including the baseline sum and this sum demonstrated an absolute increase of at least 5 millimeter (mm) or the appearance of one or more new lesions or Unequivocal progression of existing non-target lesions. All alive participants with no disease progression as of the analysis cut-off date were censored at the last tumor assessment. PFS was estimated by Kaplan-Meier method.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE) From the first dose of study treatment until 30 days after the last dose of study treatment (maximum duration: up to approximately 46 months) Any untoward medical condition that occurs in a participants while participating in a clinical study and does not necessarily have a causal relationship with the use of the study medication was considered an adverse event (AE). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs/TESAEs were defined as events that started on or after treatment or started before treatment and worsened after the start of treatment through 30 days after the last dose of study treatment.
Trial Locations
- Locations (139)
Los Angeles Cancer Network
🇺🇸Los Angeles, California, United States
Alta Bates Summit Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
St. Jude Heritage Healthcare
🇺🇸Fullerton, California, United States
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
University of Southern California - Keck School of Medicine
🇺🇸Los Angeles, California, United States
21st Century Oncology
🇺🇸Jacksonville, Florida, United States
Mount Sinai Hospital Medical Center
🇺🇸Chicago, Illinois, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Illinois CancerCare P.C.
🇺🇸Peoria, Illinois, United States
Laura & Isaac Perlmutter Cancer Center
🇺🇸New York, New York, United States
Dartmouth-Hitchcock Medical Center (DHMC)
🇺🇸Lebanon, New Hampshire, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Univeristy of Rochester Medical Center
🇺🇸Rochester, New York, United States
University of Pittsburgh Medical Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
Centre medico-chirurgical Magellan
🇫🇷Pessac, France
Coastal Bend Cancer Center
🇺🇸Corpus Christi, Texas, United States
Roger Williams Medical Center
🇺🇸Providence, Rhode Island, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Gomel Regional Clinical Oncology Dispensary
🇧🇾Gomel, Belarus
Minsk City Clinical Oncology Dispensary
🇧🇾Minsk, Belarus
Republican center for oncology and medical radiology n.a. Alexandrov
🇧🇾Minsk, Belarus
Clinique universitaire Saint Luc
🇧🇪Brussels, Belgium
Grand Hopital de Charleroi
🇧🇪Charleroi, Belgium
Recherche GCP Research
🇨🇦Montreal, Canada
Fakultni Nemocniceu sv. Anny v Brne
🇨🇿Brno, Czechia
Faculty Hospital Hradec Kralove
🇨🇿Hradec Králové, Czechia
Nemocnice Na Homolce
🇨🇿Praha, Czechia
VFN Praha
🇨🇿Praha, Czechia
Fakultní Nemocnice Olomouc
🇨🇿Olomouc, Czechia
Hopital de La Timone
🇫🇷Marseille, France
Hôpital Saint Joseph
🇫🇷Marseille, France
ICO Paul Papin
🇫🇷Angers cedex 9, France
Centre Val D'Aurelle
🇫🇷Montpellier, France
Centre Léon Bérard
🇫🇷Lyon, France
Hopital Europeen Georges Pompidou
🇫🇷Paris, France
AP-HP - HU La Pitié-Salpêtrière - Charles-Foix
🇫🇷Paris, France
Hôpital Saint-Jean
🇫🇷Perpignan, France
Centre Eugène Marquis
🇫🇷Rennes Cedex, France
Centre René Gauducheau
🇫🇷Saint Herblain, France
Technische Universitaet Muenchen
🇩🇪Muenchen, Bayern, Germany
Universitaetsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Staedtisches Krankenhaus Muenchen Neuperlach
🇩🇪Muenchen, Germany
Charite Universitaetsmedizin Berlin
🇩🇪Berlin, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Leopoldina-Krankenhaus
🇩🇪Schweinfurt, Germany
Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
Soroka Medical Centre
🇮🇱Beersheba, Israel
Hadassah Ein Karem
🇮🇱Jerusalem, Israel
Rambam healthcare campus
🇮🇱Haifa, Israel
Rabin MC Belinson Hospital
🇮🇱Petah Tikva, Israel
Sheba Medical Center
🇮🇱Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Ramat Gan, Israel
Azienda Ospedaliera San Martino
🇮🇹Genova, Italy
Gunma Prefectural Cancer Center
🇯🇵Ōta, Gunma, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa, Chiba, Japan
Ibaraki Prefectural Central Hospital
🇯🇵Kasama, Ibaraki, Japan
Sakai City Medical Center
🇯🇵Sakai, Osaka, Japan
Osaka General Medical Center
🇯🇵Osaka-shi, Osaka, Japan
Osaka National Hospital
🇯🇵Osaka-shi, Osaka, Japan
Tochigi Cancer Center
🇯🇵Utsunomiya, Tochigi, Japan
Szpital Uniwersytecki w Krakowie
🇵🇱Kraków, Poland
Iwate Medical University
🇯🇵Morioka, Japan
Górnoslaskie Centrum Medyczne im. prof. Leszka Gieca
🇵🇱Katowice, Poland
Regionalny Osrodek Onkologiczny
🇵🇱Lodz, Poland
Szpital MSWiA i Warminsko - Mazurskim Centrum Onkologii w Olsztynie
🇵🇱Olsztyn, Poland
Opolskie centrum Onkologii
🇵🇱Opole, Poland
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
🇵🇱Warszawa, Poland
Unidade Local de Saúde de Matosinhos E.P.E.- H. Pedro Hispano
🇵🇹Matosinhos, Porto, Portugal
Hospital Garcia de Orta, E.P.E.
🇵🇹Almada, Setubal, Portugal
SNS - Hospital Braga
🇵🇹Braga, Portugal
Hospital da Luz, S.A.
🇵🇹Lisboa, Portugal
Fundação Champalimaud
🇵🇹Lisboa, Portugal
Centro Hospitalar do Porto, E.P.E
🇵🇹Porto, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E.
🇵🇹Porto, Portugal
Centro Hospitalar de São João, EPE
🇵🇹Porto, Portugal
Centrul De Oncologie "Sfantul Nectarie"
🇷🇴Craiova, Dolj, Romania
Nizhegorodsky Regional Oncology Center
🇷🇺Nizhniy Novgorod, Russian Federation
Budget Institution of Healthcare Omsk Region -Clinical Oncology Dispensary
🇷🇺Omsk, Russian Federation
Saint-Petersburgskiy Oncologic Hospital
🇷🇺Saint Petersburg, Russian Federation
North-Western State Medical University n.a. I.I. Mechnikov
🇷🇺Saint Petersburg, Russian Federation
N.N.Petrov Research Institute of Oncology
🇷🇺Saint Petersburg, Russian Federation
Republican Oncology Center
🇷🇺Ufa, Russian Federation
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario Reina Sofía
🇪🇸Cordoba, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario Morales Meseguer
🇪🇸Murcia, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Baskent University Adana Practice and Research Centre Kisla
🇹🇷Adana, Turkey
Hacettepe University
🇹🇷Ankara, Turkey
Diskapi Yildirim Beyazit Training and Research Hospital
🇹🇷Ankara, Turkey
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research
🇹🇷Ankara, Turkey
Uludag University Medical Faculty
🇹🇷Bursa, Turkey
Trakya University Medical Faculty Hospital
🇹🇷Edirne, Turkey
Istanbul Üniversitesi
🇹🇷İstanbul, Turkey
Bezmialem Vakif Üniversitesi Tip Fakültesi Hastanesi
🇹🇷Istanbul, Turkey
Dokuz Eylul University Oncology Institute
🇹🇷Izmir, Turkey
East and North Hertfordshire NHS Trust
🇬🇧Northwood, Middlesex, United Kingdom
NHS Grampian
🇬🇧Aberdeen, Scotland, United Kingdom
Belfast Health and Social Care Trust - Belfast City Hospital
🇬🇧Belfast, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
Sarah Cannon Research Institute
🇬🇧London, United Kingdom
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom
The Royal Marsden NHS Foundation Trust
🇬🇧Sutton, United Kingdom
California Pacific Medical Center
🇺🇸San Francisco, California, United States
The Adelaide and Meath Hospital, Dublin, Incorporating The National Children's Hospital
🇮🇪Dublin 24, Ireland
Waterford Regional Hospital
🇮🇪Waterford, Ireland
Centro Hospitalar de Tras-os-Montes e Alto Douro, EPE
🇵🇹Vila Real, Portugal
Spitalul Judetean de Urgenta "Sfantul Ioan cel Nou" Suceava
🇷🇴Suceava, Romania
University Hospital Antwerpen
🇧🇪Edegem, Belgium
Toyama University Hospital
🇯🇵Tōyama, Toyama, Japan
Marmara University Pendik Training and Research Hospital
🇹🇷İstanbul, Turkey
St James Hospital
🇮🇪Dublin, Ireland
N.N. Blokhin Russian Cancer Research Center
🇷🇺Moscow, Russian Federation
Wolfson Medical Center
🇮🇱Holon, Israel
UZ Leuven
🇧🇪Leuven, Belgium
Istituto Europeo di Oncologia (IEO)
🇮🇹Milan, Italy
Corporacio Parc Tauli
🇪🇸Sabadell, Spain
Ankara University Medical Faculty Cebeci Hospital
🇹🇷Ankara, Turkey
IRCCS Centro di Riferimento Oncologico - Aviano
🇮🇹Aviano (PN), Italy
Humanitas Gavazzeni
🇮🇹Bergamo, Italy
Fondazione Poliambulanza Istituto Ospedaliero
🇮🇹Brescia, Italy
Struttura Complessa di Oncologia
🇮🇹Cremona, Italy
Azienda Ospedaliero - Universitaria Careggi
🇮🇹Firenze, Italy
IRCCS - Istituto Scientifico Romagnolo Per lo Studio e la Cura Dei Tumori (I.R.S.T.)
🇮🇹Meldola (FC), Italy
A.O. Ospedale 'Niguarda Ca Granda'
🇮🇹Milano, Italy
A.O.U. Seconda Universita'degli Studi di Napoli
🇮🇹Napoli, Italy
A.O.U. San Luigi Gonzaga
🇮🇹Orbassano (TO), Italy
Azienda Ospedaliero Universitaria Pisana (AOUP)
🇮🇹Pisa, Italy
A.O.R. San Carlo
🇮🇹Potenza, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano (Mi), Italy
A.O. della Valtellina e della Valchiavenna Ospedale di Sondrio
🇮🇹Sondrio, Italy
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
Guy's and St Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom