Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer

Randomized, Double-blind, Phase 3 Study Evaluating TAS-102 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Metastatic Gastric Cancer Refractory to Standard Treatments

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.

Study Overview

• Status: Completed
• Conditions: Refractory Metastatic Gastric Cancer
• Intervention / Treatment: Drug: TAS-102; Drug: Placebo

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).

• Study Type: Interventional
• Enrollment (Actual): 507
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belarus
  • Gomel, Belarus, 246012
    • Gomel Regional Clinical Oncology Dispensary
  • Minsk, Belarus, 220013
    • Minsk City Clinical Oncology Dispensary
  • Minsk, Belarus, 223040
    • Republican center for oncology and medical radiology n.a. Alexandrov
• Belgium
  • Brussels, Belgium
    • Clinique Universitaire Saint LUC
  • Charleroi, Belgium, 6000
    • Grand Hopital De Charleroi
  • Edegem, Belgium, B-2650
    • University Hospital Antwerpen
  • Leuven, Belgium
    • UZ Leuven
• Canada
  • Montreal, Canada, H1M 1M1
    • Recherche GCP Research
• Czechia
  • Brno, Czechia, 62100
    • Fakultni Nemocniceu sv. Anny v Brne
  • Hradec Králové, Czechia, 50005
    • Faculty Hospital Hradec Králové
  • Olomouc, Czechia, 77520
    • Fakultni Nemocnice Olomouc
  • Praha, Czechia
    • Nemocnice Na Homolce
  • Praha, Czechia
    • VFN Praha
• France
  • Angers cedex 9, France, 49933
    • ICO Paul Papin
  • Lyon, France, 69008
    • Centre Leon Berard
  • Marseille, France, 13005
    • Hopital de la Timone
  • Marseille, France, 13008
    • Hopital Saint Joseph
  • Montpellier, France, 34298
    • Centre Val d'Aurelle
  • Paris, France, 75015
    • Hopital Europeen Georges Pompidou
  • Paris, France, 75651
    • AP-HP - HU La Pitié-Salpêtrière - Charles-Foix
  • Perpignan, France, 66000
    • Hôpital Saint-Jean
  • Pessac, France, 33604
    • Centre medico-chirurgical Magellan
  • Rennes Cedex, France, 35042
    • Centre Eugène Marquis
  • Saint Herblain, France
    • Centre René Gauducheau
• Germany
  • Berlin, Germany, 13353
    • Charité Universitaetsmedizin Berlin
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg-Eppendorf
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Muenchen, Germany, 81737
    • Staedtisches Krankenhaus Muenchen Neuperlach
  • Schweinfurt, Germany, 97422
    • Leopoldina-Krankenhaus
  • Ulm, Germany, 89081
    • Universitaetsklinikum Ulm
  • Bayern
    • Muenchen, Bayern, Germany, 81675
      • Technische Universitaet Muenchen
• Ireland
  • Dublin, Ireland
    • St James Hospital
  • Dublin 24, Ireland
    • The Adelaide and Meath Hospital, Dublin, incorporating the National Children's Hospital
  • Waterford, Ireland
    • Waterford Regional Hospital
• Israel
  • Beersheba, Israel, 8410101
    • Soroka Medical Centre
  • Haifa, Israel, 31096
    • Rambam Healthcare Campus
  • Holon, Israel, 5822012
    • Wolfson Medical Center
  • Jerusalem, Israel, 91120
    • Hadassah Ein Karem
  • Petah Tikva, Israel, 49100
    • Rabin MC Belinson Hospital
  • Ramat Gan, Israel, 52520
    • Sheba Medical Center
  • Ramat Gan, Israel, 64239
    • Tel Aviv Sourasky Medical Center
• Italy
  • Aviano (PN), Italy, 33081
    • IRCCS Centro di Riferimento Oncologico - Aviano
  • Bergamo, Italy, 24125
    • Humanitas Gavazzeni
  • Brescia, Italy, 25124
    • Fondazione Poliambulanza Istituto Ospedaliero
  • Cremona, Italy, 26100
    • Struttura Complessa di Oncologia
  • Firenze, Italy, 50134
    • Azienda Ospedaliero - Universitaria Careggi
  • Genova, Italy, 16132
    • Azienda Ospedaliera San Martino
  • Meldola (FC), Italy, 47014
    • IRCCS - Istituto Scientifico Romagnolo Per lo Studio e la Cura Dei Tumori (I.R.S.T.)
  • Milan, Italy, 20141
    • Istituto Europeo di Oncologia (IEO)
  • Milano, Italy, 20162
    • A.O. Ospedale 'Niguarda Ca Granda'
  • Napoli, Italy, 80131
    • A.O.U. Seconda Universita'degli Studi di Napoli
  • Orbassano (TO), Italy, 10043
    • A.O.U. San Luigi Gonzaga
  • Pisa, Italy, 56126
    • Azienda Ospedaliero Universitaria Pisana (AOUP)
  • Potenza, Italy, 85100
    • A.O.R. San Carlo
  • Rozzano (Mi), Italy, 20089
    • Istituto Clinico Humanitas
  • Sondrio, Italy, 23100
    • A.O. della Valtellina e della Valchiavenna Ospedale di Sondrio
• Japan
  • Morioka, Japan, 020-8505
    • Iwate Medical University
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
  • Gunma
    • Ōta, Gunma, Japan, 373-8550
      • Gunma Prefectural Cancer Center
  • Ibaraki
    • Kasama, Ibaraki, Japan, 309-1793
      • Ibaraki Prefectural Central Hospital
  • Osaka
    • Osaka-shi, Osaka, Japan, 558-8558
      • Osaka General Medical Center
    • Osaka-shi, Osaka, Japan, 540-0006
      • Osaka National Hospital
    • Sakai, Osaka, Japan, 593-8304
      • Sakai City Medical Center
  • Tochigi
    • Utsunomiya, Tochigi, Japan, 320-0834
      • Tochigi Cancer Center
  • Toyama
    • Tōyama, Toyama, Japan, 930-0194
      • Toyama University Hospital
• Poland
  • Katowice, Poland, 40-635
    • Górnośląskie Centrum Medyczne im. Prof. Leszka Gieca
  • Kraków, Poland, 31-531
    • Szpital Uniwersytecki w Krakowie
  • Lodz, Poland, 93-513
    • Regionalny Osrodek Onkologiczny
  • Olsztyn, Poland, 10-228
    • Szpital MSWiA i Warminsko - Mazurskim Centrum Onkologii w Olsztynie
  • Opole, Poland, 45-060
    • Opolskie Centrum Onkologii
  • Warszawa, Poland, 02-781
    • Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
• Portugal
  • Braga, Portugal, 4710-243
    • SNS - Hospital Braga
  • Lisboa, Portugal, 1400-038
    • Fundacao Champalimaud
  • Lisboa, Portugal, 1500-650
    • Hospital da Luz, S.A.
  • Porto, Portugal, 4200-319
    • Centro Hospitalar de Sao Joao, EPE
  • Porto, Portugal, 4200-072
    • Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E.
  • Porto, Portugal, 4099-001
    • Centro Hospitalar do Porto, E.P.E
  • Vila Real, Portugal, 5000-259
    • Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE
  • Porto
    • Matosinhos, Porto, Portugal, 4464-513
      • Unidade Local de Saúde de Matosinhos E.P.E.- H. Pedro Hispano
  • Setubal
    • Almada, Setubal, Portugal, 2805-267
      • Hospital Garcia de Orta, E.P.E.
• Romania
  • Suceava, Romania, 720224
    • Spitalul Judetean de Urgenta "Sfantul Ioan cel Nou" Suceava
  • Dolj
    • Craiova, Dolj, Romania, 200385
      • Centrul de Oncologie "Sfântul Nectarie"
• Russian Federation
  • Moscow, Russian Federation, 115478
    • N.N. Blokhin Russian Cancer Research Center
  • Nizhniy Novgorod, Russian Federation
    • Nizhegorodsky Regional Oncology Center
  • Omsk, Russian Federation, 644013
    • Budget Institution of Healthcare Omsk Region -Clinical Oncology Dispensary
  • Saint Petersburg, Russian Federation, 195067
    • North-Western State Medical University n.a. I.I. Mechnikov
  • Saint Petersburg, Russian Federation, 197758
    • N.N.Petrov Research Institute of Oncology
  • Saint Petersburg, Russian Federation, 197758
    • Saint-Petersburgskiy Oncologic Hospital
  • Ufa, Russian Federation, 450054
    • Republican Oncology Center
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron
  • Cordoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Murcia, Spain, 30008
    • Hospital Universitario Morales Meseguer
  • Oviedo, Spain, 33006
    • Hospital Universitario Central de Asturias
  • Sabadell, Spain, 08208
    • Corporació Parc Tauli
• Turkey
  • Adana, Turkey, 1230
    • Baskent University Adana Practice and Research Centre Kisla
  • Ankara, Turkey, 6100
    • Ankara University Medical Faculty Cebeci Hospital
  • Ankara, Turkey, 6100
    • Hacettepe University
  • Ankara, Turkey, 6200
    • Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research
  • Ankara, Turkey, 6330
    • Diskapi Yildirim Beyazit Training and Research Hospital
  • Bursa, Turkey, 16059
    • Uludag University Medical Faculty
  • Edirne, Turkey, 22030
    • Trakya University Medical Faculty Hospital
  • Istanbul, Turkey, 34722
    • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
  • Izmir, Turkey, 35340
    • Dokuz Eylul University Oncology Institute
  • İstanbul, Turkey, 34098
    • Istanbul Universitesi
  • İstanbul, Turkey, 34890
    • Marmara University Pendik Training and Research Hospital
• United Kingdom
  • Belfast, United Kingdom, SM2 5NG
    • Belfast Health and Social Care Trust - Belfast City Hospital
  • Leicester, United Kingdom, LE1 5WW
    • Leicester Royal Infirmary
  • London, United Kingdom, W1G 6AD
    • Sarah Cannon Research Institute
  • London, United Kingdom, SE1 9RT
    • Guy's and St Thomas' NHS Foundation Trust
  • Manchester, United Kingdom, M20 4BX
    • The Christie NHS Foundation Trust
  • Sutton, United Kingdom, SM2 5PT
    • The Royal Marsden NHS Foundation Trust
  • Middlesex
    • Northwood, Middlesex, United Kingdom, HA6 2RN
      • East and North Hertfordshire NHS Trust
  • Scotland
    • Aberdeen, Scotland, United Kingdom, AB25 2ZN
      • NHS Grampian
• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Banner MD Anderson Cancer Center
  • California
    • Berkeley, California, United States, 94704
      • Alta Bates Summit Comprehensive Cancer Center
    • Fullerton, California, United States, 92835
      • St. Jude Heritage Healthcare
    • Los Angeles, California, United States, 90033
      • USC/Norris Comprehensive Cancer Center
    • Los Angeles, California, United States, 90033
      • University of Southern California - Keck School of Medicine
    • Los Angeles, California, United States, 90017
      • Los Angeles Cancer Network
    • San Francisco, California, United States, 94109
      • California Pacific Medical Center
  • Florida
    • Jacksonville, Florida, United States, 32204
      • 21st Century Oncology
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Chicago, Illinois, United States, 60608
      • Mount Sinai Hospital Medical Center
    • Peoria, Illinois, United States, 61615
      • Illinois CancerCare P.C.
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University Of Kentucky
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center (DHMC)
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10016
      • Laura & Isaac Perlmutter Cancer Center
    • Rochester, New York, United States, 14642
      • Univeristy of Rochester Medical Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Cancer Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02908
      • Roger Williams Medical Center
  • Texas
    • Corpus Christi, Texas, United States, 78404
      • Coastal Bend Cancer Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53792-0001
      • University of Wisconsin
    • Milwaukee, Wisconsin, United States, 53226-3522
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Has histologically confirmed non-resectable, metastatic gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction.
2. Has previously received at least 2 prior regimens for advanced disease and were refractory to or unable to tolerate their last prior therapy.
3. Has measureable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
4. Is able to take medications orally (ie, no feeding tube).
5. Has an Eastern Cooperative Oncology Group performance status of 0 or 1.
6. Has adequate organ function as defined by protocol defined labs.
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:

1. Has certain serious illnesses or medical conditions
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 previously received TAS-102.
4. Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events Grade 2 attributed to any prior therapies.
5. Is a pregnant or lactating female.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAS-102+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.	Drug: TAS-102; 35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle.
Experimental: Placebo+BSC; 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.	Drug: Placebo; 35 mg/m2/dose of placebo orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	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.	From the date of randomization to the data cut-off date (maximum duration: up to approximately 46 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	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.	From the date of randomization to the cut-off date (maximum duration: up to approximately 46 months)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE)	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.	From the first dose of study treatment until 30 days after the last dose of study treatment (maximum duration: up to approximately 46 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	Overall response rate was defined as the percentage of participants with objective evidence of complete response (CR) or partial response (PR). CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes for target lesions or all lymph nodes for non-target lesions were non-pathological morphologically that was reduced in size in short axis to < 10 mm. PR was defined as target lesions with at least 30% decrease in the sum of diameters, taking baseline sum diameters as reference.	From the date of randomization to the cut-off date (maximum duration: up to approximately 46 months), assessed every 8 weeks
Disease Control Rate (DCR)	DCR was defined as the proportion of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD). The assessment of DCR was based on Investigator review of radiologic images and following RECIST criteria (version 1.1, 2009).	From the date of randomization to the cut-off date (maximum duration: up to approximately 46 months), assessed every 8 weeks
Time to Deterioration of European Cooperative Oncology Group (ECOG) Performance Status Score From Baseline	The ECOG performance status was used to evaluate participant's disease progression and the effect of the disease on the participant's activities of daily living. It ranges on the scale from 0-5 (0 = normal activity; 1= symptoms but ambulatory; 2= in bed for < 50% of the time; 3= in bed for > 50% of the time; 4= 100% bedridden; 5= dead). Time to definitive deterioration in ECOG performance status score from baseline was defined as a change from 0, 1 to >=2, or from 2 to >=3.	At the time of randomization (Day 1 Cycle 1) and within 24 hours prior to start of study treatment in every cycle (maximum duration: up to approximately 46 months)
Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health Status	EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) and other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health and QoL, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 and 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best QoL for participant.	Baseline, Day 1 Cycle 2 up to end of treatment (EOT) (within 30 days of last study treatment) and 30-Day safety follow-up visit (maximum duration: up to approximately 46 months)
EORTC Quality of Life Questionnaire - Gastric-specific Module (EORTC QLQ-STO22): Percentage of Participants With Overall Compliance	The Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) assessed symptoms and treatment-related side effects commonly reported in participants. There are 22 questions which comprise 5 scales (dysphagia, dietary restrictions, pain QS22, reflux, and anxiety) and 4 single items (dry mouth, hair loss, taste problems, body image). Most questions use 4-point scale (1='Not at all', 2=a little, 3=quite a bit and 4='Very much'). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100, where higher score=better level of functioning or greater degree of symptoms.	Baseline, Cycle 1 Day 1 up to end of treatment (EOT) (within 30 days of last study treatment) (maximum duration: up to approximately 46 months)

Collaborators and Investigators

• Sponsor: Taiho Oncology, Inc.

Publications and helpful links

General Publications

• Tabernero J, Alsina M, Shitara K, Doi T, Dvorkin M, Mansoor W, Arkenau HT, Prokharau A, Ghidini M, Faustino C, Gorbunova V, Zhavrid E, Nishikawa K, Ando T, Yalcin S, Van Cutsem E, Sabater J, Skanji D, Leger C, Amellal N, Ilson DH. Health-related quality of life associated with trifluridine/tipiracil in heavily pretreated metastatic gastric cancer: results from TAGS. Gastric Cancer. 2020 Jul;23(4):689-698. doi: 10.1007/s10120-020-01053-9. Epub 2020 Mar 4.
• Ilson DH, Tabernero J, Prokharau A, Arkenau HT, Ghidini M, Fujitani K, Van Cutsem E, Thuss-Patience P, Beretta GD, Mansoor W, Zhavrid E, Alsina M, George B, Catenacci D, McGuigan S, Makris L, Doi T, Shitara K. Efficacy and Safety of Trifluridine/Tipiracil Treatment in Patients With Metastatic Gastric Cancer Who Had Undergone Gastrectomy: Subgroup Analyses of a Randomized Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):e193531. doi: 10.1001/jamaoncol.2019.3531. Epub 2020 Jan 9.
• Shitara K, Doi T, Dvorkin M, Mansoor W, Arkenau HT, Prokharau A, Alsina M, Ghidini M, Faustino C, Gorbunova V, Zhavrid E, Nishikawa K, Hosokawa A, Yalcin S, Fujitani K, Beretta GD, Cutsem EV, Winkler RE, Makris L, Ilson DH, Tabernero J. Trifluridine/tipiracil versus placebo in patients with heavily pretreated metastatic gastric cancer (TAGS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Nov;19(11):1437-1448. doi: 10.1016/S1470-2045(18)30739-3. Epub 2018 Oct 21. Erratum In: Lancet Oncol. 2018 Dec;19(12):e668. doi: 10.1016/S1470-2045(18)30843-X.
• Bando H, Doi T, Muro K, Yasui H, Nishina T, Yamaguchi K, Takahashi S, Nomura S, Kuno H, Shitara K, Sato A, Ohtsu A. A multicenter phase II study of TAS-102 monotherapy in patients with pre-treated advanced gastric cancer (EPOC1201). Eur J Cancer. 2016 Jul;62:46-53. doi: 10.1016/j.ejca.2016.04.009. Epub 2016 May 19.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2016
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): December 19, 2019

Study Registration Dates

• First Submitted: July 13, 2015
• First Submitted That Met QC Criteria: July 14, 2015
• First Posted (Estimated): July 16, 2015

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: August 30, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Gastric Cancer; Metastatic Gastric Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: TO-TAS-102-302; 2015-002683-16 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No