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

Primary Purpose

Refractory Metastatic Gastric Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TAS-102
Placebo
Sponsored by
Taiho Oncology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Metastatic Gastric Cancer focused on measuring Gastric Cancer, Metastatic Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

Arm Type

Experimental

Experimental

Arm Label

TAS-102+BSC

Placebo+BSC

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 13, 2015
Last Updated
August 19, 2021
Sponsor
Taiho Oncology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02500043
Brief Title
Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 24, 2016 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
December 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Oncology, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Metastatic Gastric Cancer
Keywords
Gastric Cancer, Metastatic Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
507 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAS-102+BSC
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo+BSC
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
TAS-102
Intervention Description
35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
35 mg/m2/dose of placebo orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle.
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
From the date of randomization to the data cut-off date (maximum duration: up to approximately 46 months)
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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.
Time Frame
From the date of randomization to the cut-off date (maximum duration: up to approximately 46 months)
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE)
Description
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.
Time Frame
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 Pre-specified Outcome Measures:
Title
Overall Response Rate (ORR)
Description
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.
Time Frame
From the date of randomization to the cut-off date (maximum duration: up to approximately 46 months), assessed every 8 weeks
Title
Disease Control Rate (DCR)
Description
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).
Time Frame
From the date of randomization to the cut-off date (maximum duration: up to approximately 46 months), assessed every 8 weeks
Title
Time to Deterioration of European Cooperative Oncology Group (ECOG) Performance Status Score From Baseline
Description
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.
Time Frame
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)
Title
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
Description
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.
Time Frame
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)
Title
EORTC Quality of Life Questionnaire - Gastric-specific Module (EORTC QLQ-STO22): Percentage of Participants With Overall Compliance
Description
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.
Time Frame
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)

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
32128634
Citation
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.
Results Reference
derived
PubMed Identifier
31600365
Citation
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.
Results Reference
derived
PubMed Identifier
30355453
Citation
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.
Results Reference
derived
PubMed Identifier
27208903
Citation
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.
Results Reference
derived

Learn more about this trial

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

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