AzTrials
AzTrials

Gastric CancerPhase 2/3NCT01641939

A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer

A Phase 2/3 study testing Taxane and trastuzumab emtansine in people with Gastric Cancer, run by Hoffmann-La Roche at 148 sites in 28 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This multicenter, randomized, adaptive Phase II/III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) compared to standard taxane (docetaxel or paclitaxel) treatment in participants with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
Taxane and trastuzumab emtansine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
415 participants
Where
148 sitesin 28 countries
Study dates
3 Sep 2012to 30 Apr 2016
Phase
Phase 2/3
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

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy of at least 12 weeks from the first dose of study treatment
  • Measurable and/or evaluable disease based on Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
  • Adequate organ function as determined by the following laboratory results, within 28 days prior to randomization
  • Participants must have a history of advanced gastric cancer (AGC), defined as unresectable and locally advanced or metastatic gastric cancer, including adenocarcinoma of the gastroesophageal junction (GEJ), and must have experienced disease progression during or after first-line therapy for their disease
  • HER2-positive tumor (primary tumor or metastatic lesion) as confirmed by central laboratory HER2 testing (immunohistochemistry and/or in-situ hybridization)
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  • Participants must have received at least one prior chemotherapy regimen for AGC; prior therapy does not need to have included HER2-directed therapy.
  • First-line therapy for AGC, including adenocarcinoma of the GEJ, must have included a combination of at least a platinum- and a fluoropyrimidine-based treatment given concurrently; prior therapy does not need to have included a HER2-directed therapy.
  • Adjuvant or neoadjuvant therapy for AGC is allowed.

Who cannot join

  • An interval shorter than 21 days from the last dose of chemotherapy or HER2-directed therapy until the time of randomization
  • Prior treatment with trastuzumab emtansine, docetaxel, or paclitaxel either as single agents or as part of a treatment regimen.
  • Treatment with any investigational anticancer drug within 21 days of the first study treatment administration
  • More than one prior line of therapy for advanced gastric cancer
  • History of other malignancy within the previous 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other malignancies with an expected curative outcome
  • Brain metastases that are untreated or symptomatic or require any radiation, surgery, or steroid therapy to control symptoms from brain metastases within 1 month of randomization
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  • Peripheral neuropathy Grade >/=2
  • Uncontrolled cardiopulmonary dysfunction (e.g., high blood pressure, serious cardiac arrhythmia)
  • Other current, severe, uncontrolled systemic disease (e.g., clinically significant metabolic disease, wound healing disorders, ulcers)
  • Clinically significant bleeding within 30 days before enrollment
  • For female participants, current pregnancy or lactation
  • Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
  • Infection with Human immunodeficiency virus (HIV) or hepatitis B virus, hepatitis C virus

Trial locations and contacts

148 sites in 28 countries.

148 sites in 28 countries

China20 sites

  • The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)

    Beijing, 100071

  • Beijing Cancer Hospital

    Beijing, 100142

  • Jilin Cancer Hospital

    Changchun, 130012

  • the First Hospital of Jilin University

    Changchun, 130021

  • Changzhou First People's Hospital

    Changzhou, 213003

  • Third Affiliated Hospital of Third Military Medical University

    Chongqing, 400042

  • Fujian Cancer Hospital

    Fuzhou, 350014

  • Sun Yet-sen University Cancer Center

    Guangzhou, 510060

  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

    Hangzhou, 310016

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • Jiangsu Cancer Hospital

    Nanjing, 210009

  • The 81st Hospital of P.L.A.

    Nanjing

  • Affiliated Hospital of Nantong University

    Nantong, 226001

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Zhongshan Hospital Fudan University

    Shanghai, 200032

  • Shanghai First People's Hospital

    Shanghai, 200080

  • General Hospital of Shenyang Military Command of PLA

    Shenyang, 110016

  • Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center

    Wuhan, 430023

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061

  • The Affiliated Hospital of Xuzhou Medical College

    Xuzhou, 221004

Other trials in China

Japan19 sites

  • Aichi Cancer Center Hospital; Clinical Oncology

    Aichi, 464-8681

  • Chiba Cancer Center; Gastroenterology

    Chiba, 260-8717

  • National Cancer Center Hospital East; Gastroenterology

    Chiba, 277-8577

  • National Hospital Organization Shikoku Cancer Center; Gastroenterology

    Ehime, 791-0280

  • Hokkaido University Hospital：Gastroenterology

    Hokkaido, 060-8648

  • Hyogo College Of Medicine; Upper Gastroenterology

    Hyōgo, 663-8501

  • Hyogo Cancer Center; Gastroenterology

    Hyōgo, 673-8558

  • Ibaraki Prefectural Central Hospital; Gastroenterology

    Ibaraki, 309-1793

  • Tohoku Uni Hospital; Clinical Oncology

    Miyagi, 980-8574

  • Osaka University Hospital; Surgery

    Osaka, 565-0871

  • Kindai University Hospital; Medical Oncology

    Osaka, 589-8511

  • Saitama Cancer Center; Gastroenterology

    Saitama, 362-0806

  • Shizuoka Cancer Center; Gastroenterology

    Shizuoka, 411-8777

  • Shizuoka General Hospital; Clinical Oncology

    Shizuoka, 420-8527

  • Tochigi Cancer Center; Medical Oncology

    Tochigi, 320-0834

  • National Cancer Center Hospital; Gastrointestinal Oncology

    Tokyo, 104-0045

  • Toranomon Hospital; Medical Oncology

    Tokyo, 105-8470

  • Tokyo Metropolitan Komagome Hospital; Chemotherapy

    Tokyo, 113-8677

  • The Cancer Institute Hospital, JFCR; Gastroenterology

    Tokyo, 135-8550

Other trials in Japan

United States10 sites

  • Comprehensive Blood/Cancer Ctr

    Bakersfield, California, 93309

  • Massachusetts General Hospital.

    Boston, Massachusetts, 02114

  • Dana Farber Can Ins

    Boston, Massachusetts, 02215

  • University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • Norton Healthcare Inc.

    Louisville, Kentucky, 40202

  • Vanderbilt

    Nashville, Tennessee, 37232

  • Yale Cancer Center

    New Haven, Connecticut, 06520

  • Weill Cornell Medical College

    New York, New York, 10065

  • Stanford University School of Medicine

    Stanford, California, 94305-5151

  • University of Kansas; Medical Center & Medical pavilion

    Westwood, Kansas, 66205

Other trials in United States

Spain8 sites

  • Hospital Clinic i Provincial; Servicio de Farmacia

    Barcelona, 08036

  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

    Madrid, 28007

  • Hospital Universitario La Paz; Servicio de Oncologia

    Madrid, 28046

  • Hospital Univ. Central de Asturias; Servicio de Oncologia

    Oviedo, Principality of Asturias, 33011

  • Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

    Santander, Cantabria, 39008

  • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

    Santiago de Compostela, La Coruña, 15706

  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia

    Seville, 41013

  • Hospital Universitario Miguel Servet; Servicio Oncologia

    Zaragoza, 50009

Other trials in Spain

Brazil7 sites

  • Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400

  • Hospital Amaral Carvalho

    Jaú, São Paulo, 17210-080

  • Clinica de Oncologia de Porto Alegre - CliniOnco

    Porto Alegre, Rio Grande do Sul, 90430-090

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto Nacional de Cancer - INCa; Oncologia

    Rio de Janeiro, Rio de Janeiro, 20560-120

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000

  • Instituto de Oncologia de Sorocaba - CEPOS

    Sorocaba, São Paulo, 18030-245

Other trials in Brazil

France7 sites

  • Hopital Augustin Morvan; Federation De Cancerologie

    Brest, 29200

  • Hopital Beaujon; Gastro Enterologie 1

    Clichy, 92118

  • Centre Val Aurelle Paul Lamarque; Medecine A1 A2

    Montpellier, 34298

  • Hopital Saint Antoine; Hepatologie-Gastr-Enterologie

    Paris, 75571

  • Hop Europeen Georges Pompidou; Gastro Enterologie

    Paris, 75908

  • Hopital Robert Debre; Gastro Enterologie

    Reims, 51092

  • Hopital Purpan; Unite Onco Digestive

    Toulouse, 31059

Other trials in France

Germany6 sites

  • Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.

    Berlin, 10117

  • Universitätsklinikum Köln

    Cologne, 50937

  • Universitätsklinikum "Carl Gustav Carus"; Med. Klinik & Poliklinik I, Arbeitsgr. intern. Onkologie

    Dresden, 01307

  • Facharztzentrum Eppendorf, Studien GbR

    Hamburg, 20249

  • Tagesklinik Landshut; Hämatologie/Onkologie

    Landshut, 84028

  • Onkologische Gemeinschaftspraxis

    Magdeburg, 39104

Other trials in Germany

South Korea6 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center; Medical Oncology

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Yonsei University Severance Hospital; Medical Oncology

    Seoul, 120-752

  • Korea University Anam Hospital; Oncology Haemotology

    Seoul, 136-705

  • Seoul St.Mary's Hospital; Medical Oncology

    Seoul, 137-807

Other trials in South Korea

United Kingdom6 sites

  • Velindre Cancer Centre; Oncology Dept

    Cardiff, CF14 2TL

  • The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit

    Glasgow, G12 0YN

  • Royal Marsden Hospital; Dept of Med-Onc

    London, SW3 6JJ

  • Christie Hospital Nhs Trust; Medical Oncology

    Manchester, M2O 4BX

  • Royal Marsden Hospital; Dept of Medical Oncology

    Sutton, SM2 5PT

  • BRISTOL ONCOLOGY CENTRE; CLINICAL TRIALS UNIT; R & D department

    Weston-super-Mare, BS23 4TQ

Other trials in United Kingdom

Italy5 sites

  • AZ.Osp S. Orsola - Malpighi-Reparto di Oncologia Medica

    Bologna, Emilia-Romagna, 40138

  • Campus Universitario S.Venuta; Centro Oncologico T.Campanella

    Catanzaro, Calabria, 88100

  • Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

    Florence, Tuscany, 50139

  • A.O. Universitaria Pisana; Oncologia

    Pisa, Tuscany, 56100

  • A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica

    Turin, Piedmont, 10126

Other trials in Italy

Poland5 sites

  • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

    Gdansk, 80-952

  • Szpital Uniwersytecki w Krakowie

    Krakow, 31-501

  • Wielkopolskie Centrum Onkologii; im. Marii Skłodowskiej-Curie

    Poznan, 61-866

  • Wojewódzki Szpital Specjalistyczny Nr 3

    Rybnik, 44-200

  • Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie; Klinika Gastroenterologii Onkologicznej

    Warsaw, 02-781

Other trials in Poland

Russia5 sites

  • Arkhangelsk Regional Clinical Oncology Dispensary

    Arkhangelsk, 163045

  • Ivanovo Regional Oncology Dispensary

    Ivanovo, 153040

  • Omsk Region Clinical Oncology Dispensary; 1St Sergical Department

    Omsk, 644013

  • State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary

    Pyatigorsk, 357502

  • Tula Regional Oncology Dispensary

    Tula, 300053

Other trials in Russia

Turkey (Türkiye)5 sites

  • Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department

    Erzurum, 25240

  • Istanbul Bilim University School Of Medicine; Department Of Medical Oncology

    Istanbul, 34300

  • Marmara Uni Faculty of Medicine; Medical Oncology

    Istanbul, 34890

  • Ege Uni Medical Faculty; Oncology Dept

    Izmir, 35100

  • Hacettepe Uni Medical Faculty Hospital; Oncology Dept

    Sıhhiye, Ankara, 06100

Other trials in Turkey (Türkiye)

Canada4 sites

  • Brampton Memorial Hospital, William Osler Health Center

    Brampton, Ontario, L6R 3J7

  • Toronto East General Hospital; Haematology/Oncology

    Toronto, Ontario, M4C 3E7

  • St. Michael'S Hospital

    Toronto, Ontario, M5B 1W8

  • BCCA-Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Czechia4 sites

  • Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

    Hradec Králové, 500 05

  • Fakultni nemocnice Olomouc; Onkologicka klinika

    Olomouc, 779 00

  • Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

    Prague, 128 08

  • Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni

    Prague, 150 06

Other trials in Czechia

Hungary4 sites

  • Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X

    Budapest, 1097

  • Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

    Szeged, 6720

  • Hetenyi Geza County Hospital; Onkologiai Kozpont

    Szolnok, 5004

  • Zala Megyei Kórház, Külsö Kórház, Pózva; Onkológiai Osztály

    Zalaegerszeg, 8900

Other trials in Hungary

Peru4 sites

  • Hospital Nacional Almanzor Aguinaga Asenjo; Unidad De Investigacion Del Servicio De Oncologia Medica

    Chiclayo, CIX

  • Hospital Nacional Adolfo Guevara Velasco

    Cusco, 08006

  • Hospital Nacional Edgardo Rebagliati Martins

    Jesus Maria, Lima 11

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, 34

Other trials in Peru

Romania4 sites

  • Institutul Clinic Fundeni Bucuresti

    Bucharest, 022328

  • Spitalul Universitar CF Cluj-Napoca; Sectia Oncologie

    Cluj-Napoca, 400015

  • Medisprof SRL

    Cluj-Napoca, 400058

  • Spitalul Clinic Judetean Mures; Oncologie Medicala

    Târgu Mureş, 540141

Other trials in Romania

Argentina3 sites

  • Fundación Investigar

    Buenos Aires, 1025

  • Hospital de Gastroenterologia Dr. Bonorino Udaondo ; Servicio de Oncología

    Buenos Aires, C1264AAA

  • Instituto de Oncología de Rosario

    Rosario, S2000KZE

Other trials in Argentina

Mexico3 sites

  • Centenario Hospital Miguel Hidalgo

    Aguascalientes, 20230

  • Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre

    Chihuahua City, 31000

  • Hospital General de México; Unidad de Oncologia

    Mexico City, 06726

Other trials in Mexico

Taiwan3 sites

  • Kaohsiung Chang Gung Memorial Hospital; Dept of Hem and Onc

    Kaohsung, 883

  • National Taiwan Uni Hospital; Dept of Oncology

    Taipei, 100

  • Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology

    Taoyuan, 333

Other trials in Taiwan

Guatemala2 sites

  • Centro Oncológico Sixtino / Centro Oncológico SA

    Guatemala City, 01010

  • Grupo Angeles

    Guatemala City, 01015

Other trials in Guatemala

Malaysia2 sites

  • University Malaya Medical Centre; Clinical Oncology Unit,

    Kuala Lumpur, 59100

  • Hospital Wanita dan Kanak-Kanak Sabah

    Sabah, Sabah, 88996

Other trials in Malaysia

Philippines2 sites

  • Perpetual Succour Hospital

    Cebu, 6000

  • Veterans Memorial Medical Ctr; Cancer Research Centre

    Quezon City, Luzon, 1101

Other trials in Philippines

Belgium1 site

  • UZ Leuven Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Finland1 site

  • Tampere University Hospital; Dept of Oncology

    Tampere, 33520

Other trials in Finland

Panama1 site

  • Centro Hemato Oncologico Paitilla

    Panama City, 083200752

Other trials in Panama

Singapore1 site

  • National Cancer Centre

    Singapore, 169610

Other trials in Singapore

About this study

Official title: A Randomized, Multicenter, Adaptive Phase II/III Study To Evaluate The Efficacy And Safety Of Trastuzumab Emtansine (T-DM1) Versus Taxane (Docetaxel Or Paclitaxel) In Patients With Previously Treated Locally Advanced Or Metastatic HER2-Positive Gastric Cancer, Including Adenocarcinoma Of The Gastroesophageal Junction

This multicenter, randomized, adaptive Phase II/III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) compared to standard taxane (docetaxel or paclitaxel) treatment in participants with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer. At the start of the trial (stage 1), participants will be randomized with a ratio 2:2:1 to one of three treatment arms: Arm A: trastuzumab emtansine 3.6 milligram per kilogram (mg/kg) per intravenous injection (IV) every 3 weeks; Arm B: trastuzumab emtansine 2.4 mg/kg IV every week; Arm C: standard taxane therapy (docetaxel 75 milligram per meter square [mg/m^2] IV every 3 weeks or paclitaxel 80 mg/m^2 kg IV every week per investigator choice). At the end of the first stage of the study, the dose and schedule of trastuzumab emtansine that will be used in the second stage of the study will be selected by an Independent Data Monitoring Committee (IDMC). The regimen selection analysis will be made after approximately 100 participants across all three study arms have been treated for at least 12 weeks.

Once a trastuzumab emtansine regimen has been selected, Stage I participants who were assigned to the treatment arm which was selected for Stage II of the study and participants who were in the standard taxane group will continue to receive their assigned treatment regimen. Stage I participants who were assigned to the regimen that was not selected for further evaluation will continue to receive their assigned regimen and will continue to be followed for efficacy and safety. In Stage II of the study, additional participants will be recruited and randomized with a ratio 2:1 to either the selected regimen of trastuzumab emtansine or to the standard taxane therapy. Participants will receive study treatment until disease progression, unacceptable toxicity, initiation of another cancer therapy or withdrawal.

Conditions
Gastric Cancer
Being tested
Taxane, trastuzumab emtansine
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • TaxaneDrug

    Standard taxane (docetaxel 75 mg/m^2 IV every 3 weeks or paclitaxel 80 mg/m^2) IV once a week according to investigator choice.

  • trastuzumab emtansineDrug

    trastuzumab emtansine 3.6 mg/kg IV every 3 weeks

  • trastuzumab emtansineDrug

    trastuzumab emtansine 2.4 mg/kg IV once a week

Study groups in NCT01641939
Study groupRoleWhat they receive
Standard taxane therapyActive comparatorDocetaxel will be administered at 75 milligram per meter square (mg/m^2) intravenous (IV) on Day 1 of a 21-day cycle, or paclitaxel will administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) according to investigator choice until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
Receives: Drug: Taxane
trastuzumab emtansine 2.4 mgExperimentalTrastuzumab emtansine will be administered on Day 1, 8, and 15 of a 21-day cycle at 2.4 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
Receives: Drug: trastuzumab emtansine
trastuzumab emtansine 3.6 mgExperimentalTrastuzumab emtansine will be administered on Day 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
Receives: Drug: trastuzumab emtansine

What is being measured

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

  1. Overall Survival (OS)- Phase 3

    Overall survival was defined as the time between the date of randomization and date of death due to any cause. Kaplan-Meier estimates were used for analysis. Participants for whom no death was reported prior to an analysis cutoff (30 June 2015) was censored at the latest date before the cutoff in which they were known to be alive. All data from the standard taxane therapy and trastuzumab emtansine 2.4 mg (selected treatment arm) from phase 2 and phase 3 (Stage 2) are combined into phase 3 data, and thus cumulative data are provided within the results presented for phase 3. The confirmatory analyses are restricted to comparisons between the taxane arm and the selected trastuzumab emtansine arm (2.4 mg).

    Measured: Date of randomization until death (up to 2 years 3 months)

  2. Overall Survival (OS) - Phase 2 (Dose Selection Portion of the Study)

    Overall survival was defined as the time between the date of randomization and date of death due to any cause. Kaplan-Meier estimates were used for analysis. Participants for whom no death was reported prior to an analysis cutoff (10 August 2013) was censored at the latest date before the cutoff in which they were known to be alive.

    Measured: Date of randomization until death (up to 1 year)

Secondary outcomes (15)

  1. Percentage of Participants With Disease Progression or Death According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3

    Progressive disease could base on symptom deterioration or was defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Tumor assessment was performed using modified RECIST v1.1. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.

    Measured: Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)

  2. Progression Free Survival (PFS) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3

    Progression-free survival was defined as the time between the date of randomization and the first date of documented progression or date of death due to any cause, whichever occurred first. Tumor assessment was performed using modified RECIST v1.1. Progressive disease could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Kaplan-Meier estimates were used for analysis. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure. The confirmatory analyses are restricted to comparisons between the taxane arm and the selected trastuzumab emtansine arm (2.4 mg).

    Measured: Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)

  3. Percentage of Participants With Objective Response According to mRECIST v1.1 - Phase 3

    Objective response referred to participants with complete response (CR) or partial response (PR). CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: greater than or equal to (>=) 30% decrease in sum of the longest diameter (LD) of all target lesions taking as reference the screening sum LD. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed no less than 4 weeks after the criteria for response were first met. Longer intervals as determined by the study protocol were also appropriate. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.

    Measured: Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)

  4. Duration of Objective Response (DOR) - Phase 3

    DOR: time from the date when a clinical response [CR or PR] was first documented to the date of first documented progressive disease (PD) or death. CR:disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: >= 30% decrease in sum of the LD of all target lesions taking as reference the screening sum LD. PD: could base on symptom deterioration or at least a 20% increase in the sum of diameters of target or non-target lesions and new lesions, taking as reference the smallest sum on study (nadir), including baseline. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed no less than 4 weeks after the criteria for response were first met. Longer intervals as determined by the study protocol were also appropriate. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.

    Measured: Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)

  5. Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC QLQ-C30) Score - Phase 3

    The EORTC QLQ-C30 is a validated, cancer-specific 30-item patient-reported measure, and contains 14 domains to assess the impact of cancer treatment on 5 aspects of participants functioning (physical, role, cognitive, emotional, and social), 9 aspects of disease/treatment-related symptoms (fatigue, nausea and vomiting, pain, dyspnea, insomnia, loss of appetite, constipation, diarrhea) and a global QoL/overall health status scale. Questions used 4 point scale (1 'Not at all' to 4 'Very much'; with the exception of the QoL/health status scale which uses a 7-point scale (1 'very poor' to 7 'Excellent'). Each scale is transformed on a scale of 0-100; a higher score equals (=) a better level of functioning or greater degree of symptoms. Change of greater than or equal to (>=) 10-points has been found to be clinically significant. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.

    Measured: Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at follow-up (up to 2 years 3 months)

  6. Percentage of Participants With Clinically Significant Improvement in Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) Score - Phase 3

    The Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) supplements the EORTC QLQ-C30 to assess symptoms and treatment-related side effects commonly reported in participants. There are 22 questions which comprise 5 scales (dysphagia, pain, reflux symptom, dietary restrictions, and anxiety) and 4 single items (dry mouth, hair loss, taste, body image). Most questions use 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms. Change of >=10 points has been found to be clinically significant. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.

    Measured: Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months)

  7. Percentage of Participants With Advanced Gastric Cancer (AGC) Symptom Progression - Phase 3

    AGC symptomatic progression: a worsening of >=10-points in any 1 of the abdominal discomfort, loss of appetite, weakness and fatigue, upper abdominal pain, change in bowel movement, and/or weight loss scales of the EORTC QLQ-C30 and QLQ-STO22. QLQ-STO22 supplements EORTC QLQ-C30 to assess symptoms and commonly reported treatment-related side effects. There are 22 questions comprise 5 scales (dysphagia, pain, reflux symptom, diet restrictions, anxiety), 4 single items (dry mouth, hair loss, taste, body image), which are related to the symptoms of the disease. Most questions used 4-point scale (1 'Not at all' to 4 'Very much'). All scores and single-items transformed to a scale of 0-100; higher score=better level of functioning or greater degree of symptoms. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.

    Measured: Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months)

  8. Time to Advanced Gastric Cancer (AGC) Symptom Progression - Phase 3

    Time to AGC symptom were defined as the time from randomization to the first documentation of an increase in at least one of the pre-specified abdominal discomfort, loss of appetite, weakness and fatigue, upper abdominal pain, change in bowel movement, and weight loss subscales of the QLQ STO22 and EORTC QLQ-C30. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.

    Measured: Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months)

  9. Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 1

    Maximum observed plasma concentration of Trastuzumab Emtansine (T-DM1) and total trastuzumab were reported. Stage 1 consists of all participants recruited before the regimen selection, which was carried out after 12 weeks of randomization.

    Measured: Day 1 (D1) of Cycle 1 (C1) and C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)

  10. Maximum Observed Plasma Concentration (Cmax) of N2'-Deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maytansine (DM1) - Stage 1

    Maximum observed plasma concentration of DM1 were reported. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.

    Measured: C1D1 and C1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)

  11. Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 2

    Stage 2 consists of all participants recruited after the regimen selection decision up to primary data cut-off date 30-June-2015.

    Measured: C1D1; C4D1

  12. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] - Stage 1

    AUCinf= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf). Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.

    Measured: D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)

  13. Plasma Decay Half-Life (t1/2) - Stage 1

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.

    Measured: D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)

  14. Volume of Distribution at Steady State (Vss) - Stage 1

    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.

    Measured: D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)

  15. Systemic Clearance (CL) - Stage 1

    CL is a quantitative measure of the rate at which a drug substance is removed from the body. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.

    Measured: D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)

Timeline

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

  1. First posted17 Jul 2012 (estimated)
  2. Study start3 Sep 2012
  3. Primary completion30 Jun 2015
  4. Study completion30 Apr 2016

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
415 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01641939
Sponsor's protocol ID
BO27952
Other IDs
2012-000660-22
Status last verified
May 2017
First submitted
13 Jul 2012
Last updated
12 May 2017

Publications

  • Shah MA, Kang YK, Thuss-Patience PC, Ohtsu A, Ajani JA, Van Cutsem E, Hoersch S, Harle-Yge ML, de Haas SL. Biomarker analysis of the GATSBY study of trastuzumab emtansine versus a taxane in previously treated HER2-positive advanced gastric/gastroesophageal junction cancer. Gastric Cancer. 2019 Jul;22(4):803-816. doi: 10.1007/s10120-018-00923-7. Epub 2019 Jan 31.

    PubMed 30706247

  • Thuss-Patience PC, Shah MA, Ohtsu A, Van Cutsem E, Ajani JA, Castro H, Mansoor W, Chung HC, Bodoky G, Shitara K, Phillips GDL, van der Horst T, Harle-Yge ML, Althaus BL, Kang YK. Trastuzumab emtansine versus taxane use for previously treated HER2-positive locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma (GATSBY): an international randomised, open-label, adaptive, phase 2/3 study. Lancet Oncol. 2017 May;18(5):640-653. doi: 10.1016/S1470-2045(17)30111-0. Epub 2017 Mar 23.

    PubMed 28343975

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Taxane and trastuzumab emtansine in people with Gastric Cancer, run by Hoffmann-La Roche at 148 sites in 28 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 9 inclusion and 13 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: stopped early, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 148 sites in China, Japan, United States, Spain, Brazil and 23 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 11 Aug 2016). 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)- Phase 3 (time frame: Date of randomization until death (up to 2 years 3 months)). The study lists 2 primary outcomes in all. 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 NCT01641939, which also lists 2 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 12 May 2017.

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