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Refractory Metastatic Gastric CancerPhase 3NCT02500043

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

A Phase 3 study testing TAS-102 in people with Refractory Metastatic Gastric Cancer, run by Taiho Oncology, Inc. at 139 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Refractory Metastatic Gastric Cancer
What is being tested?
TAS-102
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
507 participants
Where
139 sitesin 18 countries
Study dates
24 Feb 2016to 19 Dec 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

139 sites in 18 countries.

139 sites in 18 countries

United States24 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Alta Bates Summit Comprehensive Cancer Center

    Berkeley, California, 94704

  • Mount Sinai Hospital Medical Center

    Chicago, Illinois, 60608

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • Coastal Bend Cancer Center

    Corpus Christi, Texas, 78404

  • St. Jude Heritage Healthcare

    Fullerton, California, 92835

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • 21st Century Oncology

    Jacksonville, Florida, 32204

  • Dartmouth-Hitchcock Medical Center (DHMC)

    Lebanon, New Hampshire, 03756

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Los Angeles Cancer Network

    Los Angeles, California, 90017

  • University of Southern California - Keck School of Medicine

    Los Angeles, California, 90033

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • University of Wisconsin

    Madison, Wisconsin, 53792-0001

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226-3522

  • Laura & Isaac Perlmutter Cancer Center

    New York, New York, 10016

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Illinois CancerCare P.C.

    Peoria, Illinois, 61615

  • University of Pittsburgh Medical Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Roger Williams Medical Center

    Providence, Rhode Island, 02908

  • Univeristy of Rochester Medical Center

    Rochester, New York, 14642

  • California Pacific Medical Center

    San Francisco, California, 94109

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

Other trials in United States

Italy15 sites

  • IRCCS Centro di Riferimento Oncologico - Aviano

    Aviano (PN), 33081

  • Humanitas Gavazzeni

    Bergamo, 24125

  • Fondazione Poliambulanza Istituto Ospedaliero

    Brescia, 25124

  • Struttura Complessa di Oncologia

    Cremona, 26100

  • Azienda Ospedaliero - Universitaria Careggi

    Florence, 50134

  • Azienda Ospedaliera San Martino

    Genova, 16132

  • IRCCS - Istituto Scientifico Romagnolo Per lo Studio e la Cura Dei Tumori (I.R.S.T.)

    Meldola (FC), 47014

  • Istituto Europeo di Oncologia (IEO)

    Milan, 20141

  • A.O. Ospedale 'Niguarda Ca Granda'

    Milan, 20162

  • A.O.U. Seconda Universita'degli Studi di Napoli

    Naples, 80131

  • A.O.U. San Luigi Gonzaga

    Orbassano (TO), 10043

  • Azienda Ospedaliero Universitaria Pisana (AOUP)

    Pisa, 56126

  • A.O.R. San Carlo

    Potenza, 85100

  • Istituto Clinico Humanitas

    Rozzano (Mi), 20089

  • A.O. della Valtellina e della Valchiavenna Ospedale di Sondrio

    Sondrio, 23100

Other trials in Italy

France11 sites

  • ICO Paul Papin

    Angers, 49933

  • Centre Léon Bérard

    Lyon, 69008

  • Hopital de La Timone

    Marseille, 13005

  • Hôpital Saint Joseph

    Marseille, 13008

  • Centre Val D'Aurelle

    Montpellier, 34298

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • AP-HP - HU La Pitié-Salpêtrière - Charles-Foix

    Paris, 75651

  • Hôpital Saint-Jean

    Perpignan, 66000

  • Centre medico-chirurgical Magellan

    Pessac, 33604

  • Centre Eugène Marquis

    Rennes, 35042

  • Centre René Gauducheau

    Saint-Herblain

Other trials in France

Turkey (Türkiye)11 sites

  • Baskent University Adana Practice and Research Centre Kisla

    Adana, 1230

  • Ankara University Medical Faculty Cebeci Hospital

    Ankara, 6100

  • Hacettepe University

    Ankara, 6100

  • Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research

    Ankara, 6200

  • Diskapi Yildirim Beyazit Training and Research Hospital

    Ankara, 6330

  • Uludag University Medical Faculty

    Bursa, 16059

  • Trakya University Medical Faculty Hospital

    Edirne, 22030

  • Istanbul Üniversitesi

    Istanbul, 34098

  • Bezmialem Vakif Üniversitesi Tip Fakültesi Hastanesi

    Istanbul, 34722

  • Marmara University Pendik Training and Research Hospital

    Istanbul, 34890

  • Dokuz Eylul University Oncology Institute

    Izmir, 35340

Other trials in Turkey (Türkiye)

Japan9 sites

  • Ibaraki Prefectural Central Hospital

    Kasama, Ibaraki, 309-1793

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • Iwate Medical University

    Morioka, 020-8505

  • Osaka National Hospital

    Osaka, Osaka, 540-0006

  • Osaka General Medical Center

    Osaka, Osaka, 558-8558

  • Gunma Prefectural Cancer Center

    Ōta, Gunma, 373-8550

  • Sakai City Medical Center

    Sakai, Osaka, 593-8304

  • Toyama University Hospital

    Tōyama, Toyama, 930-0194

  • Tochigi Cancer Center

    Utsunomiya, Tochigi, 320-0834

Other trials in Japan

Portugal9 sites

  • Hospital Garcia de Orta, E.P.E.

    Almada, Setúbal District, 2805-267

  • SNS - Hospital Braga

    Braga, 4710-243

  • Fundação Champalimaud

    Lisbon, 1400-038

  • Hospital da Luz, S.A.

    Lisbon, 1500-650

  • Unidade Local de Saúde de Matosinhos E.P.E.- H. Pedro Hispano

    Matosinhos Municipality, Porto District, 4464-513

  • Centro Hospitalar do Porto, E.P.E

    Porto, 4099-001

  • Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E.

    Porto, 4200-072

  • Centro Hospitalar de São João, EPE

    Porto, 4200-319

  • Centro Hospitalar de Tras-os-Montes e Alto Douro, EPE

    Vila Real, 5000-259

Other trials in Portugal

United Kingdom8 sites

  • NHS Grampian

    Aberdeen, Scotland, AB25 2ZN

  • Belfast Health and Social Care Trust - Belfast City Hospital

    Belfast, SM2 5NG

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 9RT

  • Sarah Cannon Research Institute

    London, W1G 6AD

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • East and North Hertfordshire NHS Trust

    Northwood, Middlesex, HA6 2RN

  • The Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT

Other trials in United Kingdom

Germany7 sites

  • Charite Universitaetsmedizin Berlin

    Berlin, 13353

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Staedtisches Krankenhaus Muenchen Neuperlach

    München, 81737

  • Technische Universitaet Muenchen

    Munich, Bavaria, 81675

  • Leopoldina-Krankenhaus

    Schweinfurt, 97422

  • Universitaetsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Israel7 sites

  • Soroka Medical Centre

    Beersheba, 8410101

  • Rambam healthcare campus

    Haifa, 31096

  • Wolfson Medical Center

    Holon, 5822012

  • Hadassah Ein Karem

    Jerusalem, 91120

  • Rabin MC Belinson Hospital

    Petah Tikva, 49100

  • Sheba Medical Center

    Ramat Gan, 52520

  • Tel Aviv Sourasky Medical Center

    Ramat Gan, 64239

Other trials in Israel

Russia7 sites

  • N.N. Blokhin Russian Cancer Research Center

    Moscow, 115478

  • Nizhegorodsky Regional Oncology Center

    Nizhny Novgorod

  • Budget Institution of Healthcare Omsk Region -Clinical Oncology Dispensary

    Omsk, 644013

  • North-Western State Medical University n.a. I.I. Mechnikov

    Saint Petersburg, 195067

  • N.N.Petrov Research Institute of Oncology

    Saint Petersburg, 197758

  • Saint-Petersburgskiy Oncologic Hospital

    Saint Petersburg, 197758

  • Republican Oncology Center

    Ufa, 450054

Other trials in Russia

Spain7 sites

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Morales Meseguer

    Murcia, 30008

  • Hospital Universitario Central de Asturias

    Oviedo, 33006

  • Corporacio Parc Tauli

    Sabadell, 08208

Other trials in Spain

Poland6 sites

  • Górnoslaskie Centrum Medyczne im. prof. Leszka Gieca

    Katowice, 40-635

  • Szpital Uniwersytecki w Krakowie

    Krakow, 31-531

  • Regionalny Osrodek Onkologiczny

    Lodz, 93-513

  • Szpital MSWiA i Warminsko - Mazurskim Centrum Onkologii w Olsztynie

    Olsztyn, 10-228

  • Opolskie centrum Onkologii

    Opole, 45-060

  • Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

    Warsaw, 02-781

Other trials in Poland

Czechia5 sites

  • Fakultni Nemocniceu sv. Anny v Brne

    Brno, 62100

  • Faculty Hospital Hradec Kralove

    Hradec Králové, 50005

  • Fakultní Nemocnice Olomouc

    Olomouc, 77520

  • Nemocnice Na Homolce

    Prague

  • VFN Praha

    Prague

Other trials in Czechia

Belgium4 sites

  • Clinique universitaire Saint Luc

    Brussels

  • Grand Hopital de Charleroi

    Charleroi, 6000

  • University Hospital Antwerpen

    Edegem, B-2650

  • UZ Leuven

    Leuven

Other trials in Belgium

Belarus3 sites

  • Gomel Regional Clinical Oncology Dispensary

    Homyel, 246012

  • Minsk City Clinical Oncology Dispensary

    Minsk, 220013

  • Republican center for oncology and medical radiology n.a. Alexandrov

    Minsk, 223040

Other trials in Belarus

Ireland3 sites

  • St James Hospital

    Dublin

  • The Adelaide and Meath Hospital, Dublin, Incorporating The National Children's Hospital

    Dublin

  • Waterford Regional Hospital

    Waterford

Other trials in Ireland

Romania2 sites

  • Centrul De Oncologie "Sfantul Nectarie"

    Craiova, Dolj, 200385

  • Spitalul Judetean de Urgenta "Sfantul Ioan cel Nou" Suceava

    Suceava, 720224

Other trials in Romania

Canada1 site

  • Recherche GCP Research

    Montreal, H1M 1M1

Other trials in Canada

About this study

Official title: 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.

Read the 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).

Being tested
TAS-102, Placebo
Keywords
Gastric Cancer, Metastatic Gastric Cancer
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAS-102Drug

    35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle.

  • PlaceboDrug

    35 mg/m2/dose of placebo orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle.

Study groups in NCT02500043
Study groupRoleWhat they receive
TAS-102+BSCExperimentalParticipants 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.
Receives: Drug: TAS-102
Placebo+BSCExperimentalParticipants 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From the date of randomization to the data cut-off date (maximum duration: up to approximately 46 months)

Secondary outcomes (2)

  1. 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.

    Measured: From the date of randomization to the cut-off date (maximum duration: up to approximately 46 months)

  2. 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.

    Measured: From the first dose of study treatment until 30 days after the last dose of study treatment (maximum duration: up to approximately 46 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2015 (estimated)
  2. Study start24 Feb 2016
  3. Primary completion30 Apr 2018
  4. Study completion19 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
507 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02500043
Sponsor's protocol ID
TO-TAS-102-302
Other IDs
2015-002683-16, 2015
Status last verified
Aug 2024
First submitted
13 Jul 2015
Last updated
3 Sep 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Ying T, Xia R, Zhang Y, Dai J, Wang Y, Xie X. Cost-effectiveness analysis of trifluridine/tipiracil in the treatment of heavily pretreated metastatic gastric cancer from the perspective of Chinese healthcare system. BMJ Open. 2024 Nov 7;14(11):e080846. doi: 10.1136/bmjopen-2023-080846.

    PubMed 39510786

  • Shitara K, George B, Taieb J, Sundar R, Fakih MG, Makris L, Benhadji KA, Ghidini M. Effects of prior therapies on outcomes with trifluridine/tipiracil in patients with metastatic gastric/gastroesophageal junction cancer in a randomized phase III trial (TAGS). J Cancer Res Clin Oncol. 2023 Sep;149(11):9361-9374. doi: 10.1007/s00432-023-04813-z. Epub 2023 May 22.

    PubMed 37213030

  • 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.

    PubMed 32128634

  • 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.

    PubMed 31600365

  • 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.

    PubMed 30355453

  • 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.

    PubMed 27208903

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAS-102 in people with Refractory Metastatic Gastric Cancer, run by Taiho Oncology, Inc. at 139 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 139 sites in United States, Italy, France, Turkey (Türkiye), Japan and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From the date of randomization to the data cut-off date (maximum duration: up to approximately 46 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02500043, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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