Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer
Refractory Metastatic Gastric Cancer
About this trial
This is an interventional treatment trial for Refractory Metastatic Gastric Cancer focused on measuring Gastric Cancer, Metastatic Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Banner MD Anderson Cancer Center
- Alta Bates Summit Comprehensive Cancer Center
- St. Jude Heritage Healthcare
- Los Angeles Cancer Network
- University of Southern California - Keck School of Medicine
- USC/Norris Comprehensive Cancer Center
- California Pacific Medical Center
- 21st Century Oncology
- Mount Sinai Hospital Medical Center
- Rush University Medical Center
- University of Chicago
- Illinois CancerCare P.C.
- University of Kentucky
- University of Michigan
- Dartmouth-Hitchcock Medical Center (DHMC)
- Laura & Isaac Perlmutter Cancer Center
- Memorial Sloan Kettering Cancer Center
- Univeristy of Rochester Medical Center
- Wake Forest Baptist Health
- University of Pittsburgh Medical Cancer Center
- Roger Williams Medical Center
- Coastal Bend Cancer Center
- University of Wisconsin
- Medical College of Wisconsin
- Gomel Regional Clinical Oncology Dispensary
- Minsk City Clinical Oncology Dispensary
- Republican center for oncology and medical radiology n.a. Alexandrov
- Clinique universitaire Saint Luc
- Grand Hopital de Charleroi
- University Hospital Antwerpen
- UZ Leuven
- Recherche GCP Research
- Fakultni Nemocniceu sv. Anny v Brne
- Faculty Hospital Hradec Kralove
- Fakultní Nemocnice Olomouc
- Nemocnice Na Homolce
- VFN Praha
- ICO Paul Papin
- Centre Léon Bérard
- Hopital de La Timone
- Hôpital Saint Joseph
- Centre Val D'Aurelle
- Hopital Europeen Georges Pompidou
- AP-HP - HU La Pitié-Salpêtrière - Charles-Foix
- Hôpital Saint-Jean
- Centre medico-chirurgical Magellan
- Centre Eugène Marquis
- Centre René Gauducheau
- Technische Universitaet Muenchen
- Charite Universitaetsmedizin Berlin
- Universitaetsklinikum Hamburg-Eppendorf
- Medizinische Hochschule Hannover
- Staedtisches Krankenhaus Muenchen Neuperlach
- Leopoldina-Krankenhaus
- Universitaetsklinikum Ulm
- The Adelaide and Meath Hospital, Dublin, Incorporating The National Children's Hospital
- St James Hospital
- Waterford Regional Hospital
- Soroka Medical Centre
- Rambam healthcare campus
- Wolfson Medical Center
- Hadassah Ein Karem
- Rabin MC Belinson Hospital
- Sheba Medical Center
- Tel Aviv Sourasky Medical Center
- IRCCS Centro di Riferimento Oncologico - Aviano
- Humanitas Gavazzeni
- Fondazione Poliambulanza Istituto Ospedaliero
- Struttura Complessa di Oncologia
- Azienda Ospedaliero - Universitaria Careggi
- Azienda Ospedaliera San Martino
- IRCCS - Istituto Scientifico Romagnolo Per lo Studio e la Cura Dei Tumori (I.R.S.T.)
- A.O. Ospedale 'Niguarda Ca Granda'
- Istituto Europeo di Oncologia (IEO)
- A.O.U. Seconda Universita'degli Studi di Napoli
- A.O.U. San Luigi Gonzaga
- Azienda Ospedaliero Universitaria Pisana (AOUP)
- A.O.R. San Carlo
- Istituto Clinico Humanitas
- A.O. della Valtellina e della Valchiavenna Ospedale di Sondrio
- National Cancer Center Hospital East
- Gunma Prefectural Cancer Center
- Ibaraki Prefectural Central Hospital
- Osaka National Hospital
- Osaka General Medical Center
- Sakai City Medical Center
- Tochigi Cancer Center
- Toyama University Hospital
- Iwate Medical University
- Górnoslaskie Centrum Medyczne im. prof. Leszka Gieca
- Szpital Uniwersytecki w Krakowie
- Regionalny Osrodek Onkologiczny
- Szpital MSWiA i Warminsko - Mazurskim Centrum Onkologii w Olsztynie
- Opolskie centrum Onkologii
- Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
- Unidade Local de Saúde de Matosinhos E.P.E.- H. Pedro Hispano
- Hospital Garcia de Orta, E.P.E.
- SNS - Hospital Braga
- Fundação Champalimaud
- Hospital da Luz, S.A.
- Centro Hospitalar do Porto, E.P.E
- Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E.
- Centro Hospitalar de São João, EPE
- Centro Hospitalar de Tras-os-Montes e Alto Douro, EPE
- Centrul De Oncologie "Sfantul Nectarie"
- Spitalul Judetean de Urgenta "Sfantul Ioan cel Nou" Suceava
- N.N. Blokhin Russian Cancer Research Center
- Nizhegorodsky Regional Oncology Center
- Budget Institution of Healthcare Omsk Region -Clinical Oncology Dispensary
- North-Western State Medical University n.a. I.I. Mechnikov
- N.N.Petrov Research Institute of Oncology
- Saint-Petersburgskiy Oncologic Hospital
- Republican Oncology Center
- Hospital Universitario Vall d'Hebron
- Hospital Universitario Reina Sofía
- Hospital Universitario Ramon y Cajal
- Hospital Universitario La Paz
- Hospital Universitario Morales Meseguer
- Hospital Universitario Central de Asturias
- Corporacio Parc Tauli
- Baskent University Adana Practice and Research Centre Kisla
- Ankara University Medical Faculty Cebeci Hospital
- Hacettepe University
- Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research
- Diskapi Yildirim Beyazit Training and Research Hospital
- Uludag University Medical Faculty
- Trakya University Medical Faculty Hospital
- Istanbul Üniversitesi
- Bezmialem Vakif Üniversitesi Tip Fakültesi Hastanesi
- Marmara University Pendik Training and Research Hospital
- Dokuz Eylul University Oncology Institute
- East and North Hertfordshire NHS Trust
- NHS Grampian
- Belfast Health and Social Care Trust - Belfast City Hospital
- Leicester Royal Infirmary
- Guy's and St Thomas' NHS Foundation Trust
- Sarah Cannon Research Institute
- The Christie NHS Foundation Trust
- The Royal Marsden NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
TAS-102+BSC
Placebo+BSC
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.
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.