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

Primary Purpose

Gastric Cancer

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Taxane

trastuzumab emtansine

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

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

Inclusion Criteria:

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)
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.

Exclusion Criteria:

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
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

Sites / Locations

Comprehensive Blood/Cancer Ctr
Stanford University School of Medicine
Yale Cancer Center
University of Kansas; Medical Center & Medical pavilion
Norton Healthcare Inc.
Massachusetts General Hospital.
Dana Farber Can Ins
Weill Cornell Medical College
Vanderbilt
University of Texas M.D. Anderson Cancer Center
Fundación Investigar
Hospital de Gastroenterologia Dr. Bonorino Udaondo ; Servicio de Oncología
Instituto de Oncología de Rosario
UZ Leuven Gasthuisberg
Instituto Nacional de Cancer - INCa; Oncologia
Clinica de Oncologia de Porto Alegre - CliniOnco
Hospital Sao Lucas - PUCRS
Hospital de Cancer de Barretos
Hospital Amaral Carvalho
Instituto do Cancer do Estado de Sao Paulo - ICESP
Instituto de Oncologia de Sorocaba - CEPOS
BCCA-Vancouver Cancer Centre
Brampton Memorial Hospital, William Osler Health Center
Toronto East General Hospital; Haematology/Oncology
St. Michael'S Hospital
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
Beijing Cancer Hospital
Jilin Cancer Hospital
the First Hospital of Jilin University
Changzhou First People's Hospital
Third Affiliated Hospital of Third Military Medical University
Fujian Cancer Hospital
Sun Yet-sen University Cancer Center
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Harbin Medical University Cancer Hospital
Jiangsu Cancer Hospital
The 81st Hospital of P.L.A.
Affiliated Hospital of Nantong University
Fudan University Shanghai Cancer Center
Zhongshan Hospital Fudan University
Shanghai First People's Hospital
General Hospital of Shenyang Military Command of PLA
Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
The Affiliated Hospital of Xuzhou Medical College
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
Fakultni nemocnice Olomouc; Onkologicka klinika
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni
Tampere University Hospital; Dept of Oncology
Hopital Augustin Morvan; Federation De Cancerologie
Hopital Beaujon; Gastro Enterologie 1
Centre Val Aurelle Paul Lamarque; Medecine A1 A2
Hopital Saint Antoine; Hepatologie-Gastr-Enterologie
Hop Europeen Georges Pompidou; Gastro Enterologie
Hopital Robert Debre; Gastro Enterologie
Hopital Purpan; Unite Onco Digestive
Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.
Universitätsklinikum "Carl Gustav Carus"; Med. Klinik & Poliklinik I, Arbeitsgr. intern. Onkologie
Facharztzentrum Eppendorf, Studien GbR
Universitätsklinikum Köln
Tagesklinik Landshut; Hämatologie/Onkologie
Onkologische Gemeinschaftspraxis
Grupo Angeles
Centro Oncológico Sixtino / Centro Oncológico SA
Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
Hetenyi Geza County Hospital; Onkologiai Kozpont
Zala Megyei Kórház, Külsö Kórház, Pózva; Onkológiai Osztály
Campus Universitario S.Venuta; Centro Oncologico T.Campanella
AZ.Osp S. Orsola - Malpighi-Reparto di Oncologia Medica
A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica
Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
A.O. Universitaria Pisana; Oncologia
Aichi Cancer Center Hospital; Clinical Oncology
Chiba Cancer Center; Gastroenterology
National Cancer Center Hospital East; Gastroenterology
National Hospital Organization Shikoku Cancer Center; Gastroenterology
Hokkaido University Hospital：Gastroenterology
Hyogo College Of Medicine; Upper Gastroenterology
Hyogo Cancer Center; Gastroenterology
Ibaraki Prefectural Central Hospital; Gastroenterology
Tohoku Uni Hospital; Clinical Oncology
Osaka University Hospital; Surgery
Kindai University Hospital; Medical Oncology
Saitama Cancer Center; Gastroenterology
Shizuoka Cancer Center; Gastroenterology
Shizuoka General Hospital; Clinical Oncology
Tochigi Cancer Center; Medical Oncology
National Cancer Center Hospital; Gastrointestinal Oncology
Toranomon Hospital; Medical Oncology
Tokyo Metropolitan Komagome Hospital; Chemotherapy
The Cancer Institute Hospital, JFCR; Gastroenterology
Seoul National University Hospital
Asan Medical Center; Medical Oncology
Samsung Medical Center
Yonsei University Severance Hospital; Medical Oncology
Korea University Anam Hospital; Oncology Haemotology
Seoul St.Mary's Hospital; Medical Oncology
University Malaya Medical Centre; Clinical Oncology Unit,
Hospital Wanita dan Kanak-Kanak Sabah
Centenario Hospital Miguel Hidalgo
Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre
Hospital General de México; Unidad de Oncologia
Centro Hemato Oncologico Paitilla
Hospital Nacional Almanzor Aguinaga Asenjo; Unidad De Investigacion Del Servicio De Oncologia Medica
Hospital Nacional Adolfo Guevara Velasco
Hospital Nacional Edgardo Rebagliati Martins
Instituto Nacional de Enfermedades Neoplasicas
Perpetual Succour Hospital
Veterans Memorial Medical Ctr; Cancer Research Centre
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Szpital Uniwersytecki w Krakowie
Wielkopolskie Centrum Onkologii; im. Marii Skłodowskiej-Curie
Wojewódzki Szpital Specjalistyczny Nr 3
Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie; Klinika Gastroenterologii Onkologicznej
Institutul Clinic Fundeni Bucuresti
Spitalul Universitar CF Cluj-Napoca; Sectia Oncologie
Medisprof SRL
Spitalul Clinic Judetean Mures; Oncologie Medicala
Arkhangelsk Regional Clinical Oncology Dispensary
Ivanovo Regional Oncology Dispensary
Omsk Region Clinical Oncology Dispensary; 1St Sergical Department
State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary
Tula Regional Oncology Dispensary
National Cancer Centre
Hospital Univ. Central de Asturias; Servicio de Oncologia
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
Hospital Clinic i Provincial; Servicio de Farmacia
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Hospital Universitario La Paz; Servicio de Oncologia
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Hospital Universitario Miguel Servet; Servicio Oncologia
Kaohsiung Chang Gung Memorial Hospital; Dept of Hem and Onc
National Taiwan Uni Hospital; Dept of Oncology
Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
Istanbul Bilim University School Of Medicine; Department Of Medical Oncology
Marmara Uni Faculty of Medicine; Medical Oncology
Ege Uni Medical Faculty; Oncology Dept
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Velindre Cancer Centre; Oncology Dept
The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit
Royal Marsden Hospital; Dept of Med-Onc
Christie Hospital Nhs Trust; Medical Oncology
Royal Marsden Hospital; Dept of Medical Oncology
BRISTOL ONCOLOGY CENTRE; CLINICAL TRIALS UNIT; R & D department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Standard taxane therapy

trastuzumab emtansine 2.4 mg

trastuzumab emtansine 3.6 mg

Arm Description

Docetaxel 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.

Trastuzumab 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.

Trastuzumab 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.

Outcomes

Primary Outcome Measures

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).

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

Secondary Outcome Measures

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT01641939

First Posted

July 13, 2012

Last Updated

May 5, 2017

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT01641939

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Terminated

Study Start Date

September 3, 2012 (Actual)

Primary Completion Date

June 30, 2015 (Actual)

Study Completion Date

April 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

415 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard taxane therapy

Arm Type

Active Comparator

Arm Description

Arm Title

trastuzumab emtansine 2.4 mg

Arm Type

Experimental

Arm Description

Arm Title

trastuzumab emtansine 3.6 mg

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Taxane

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

trastuzumab emtansine

Intervention Description

trastuzumab emtansine 3.6 mg/kg IV every 3 weeks

Intervention Type

Drug

Intervention Name(s)

trastuzumab emtansine

Intervention Description

trastuzumab emtansine 2.4 mg/kg IV once a week

Primary Outcome Measure Information:

Title

Overall Survival (OS)- Phase 3

Description

Time Frame

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

Title

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

Description

Time Frame

Date of randomization until death (up to 1 year)

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Duration of Objective Response (DOR) - Phase 3

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

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

Time Frame

C1D1; C4D1

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Systemic Clearance (CL) - Stage 1

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) 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. Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

Facility Name

Comprehensive Blood/Cancer Ctr

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305-5151

Country

United States

Facility Name

Yale Cancer Center

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Facility Name

University of Kansas; Medical Center & Medical pavilion

City

Westwood

State/Province

Kansas

ZIP/Postal Code

66205

Country

United States

Facility Name

Norton Healthcare Inc.

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Massachusetts General Hospital.

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Dana Farber Can Ins

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Weill Cornell Medical College

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Vanderbilt

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

University of Texas M.D. Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Fundación Investigar

City

Buenos Aires

ZIP/Postal Code

1025

Country

Argentina

Facility Name

Hospital de Gastroenterologia Dr. Bonorino Udaondo ; Servicio de Oncología

City

Buenos Aires

ZIP/Postal Code

C1264AAA

Country

Argentina

Facility Name

Instituto de Oncología de Rosario

City

Rosario

ZIP/Postal Code

S2000KZE

Country

Argentina

Facility Name

UZ Leuven Gasthuisberg

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Instituto Nacional de Cancer - INCa; Oncologia

City

Rio de Janeiro

State/Province

ZIP/Postal Code

20560-120

Country

Brazil

Facility Name

Clinica de Oncologia de Porto Alegre - CliniOnco

City

Porto Alegre

State/Province

ZIP/Postal Code

90430-090

Country

Brazil

Facility Name

Hospital Sao Lucas - PUCRS

City

Porto Alegre

State/Province

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

Hospital de Cancer de Barretos

City

Barretos

State/Province

ZIP/Postal Code

14784-400

Country

Brazil

Facility Name

Hospital Amaral Carvalho

City

Jau

State/Province

ZIP/Postal Code

17210-080

Country

Brazil

Facility Name

Instituto do Cancer do Estado de Sao Paulo - ICESP

City

Sao Paulo

State/Province

ZIP/Postal Code

01246-000

Country

Brazil

Facility Name

Instituto de Oncologia de Sorocaba - CEPOS

City

Sorocaba

State/Province

ZIP/Postal Code

18030-245

Country

Brazil

Facility Name

BCCA-Vancouver Cancer Centre

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

Facility Name

Brampton Memorial Hospital, William Osler Health Center

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6R 3J7

Country

Canada

Facility Name

Toronto East General Hospital; Haematology/Oncology

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4C 3E7

Country

Canada

Facility Name

St. Michael'S Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1W8

Country

Canada

Facility Name

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

City

Beijing

ZIP/Postal Code

100071

Country

China

Facility Name

Beijing Cancer Hospital

City

Beijing

ZIP/Postal Code

100142

Country

China

Facility Name

Jilin Cancer Hospital

City

Changchun

ZIP/Postal Code

130012

Country

China

Facility Name

the First Hospital of Jilin University

City

Changchun

ZIP/Postal Code

130021

Country

China

Facility Name

Changzhou First People's Hospital

City

Changzhou

ZIP/Postal Code

213003

Country

China

Facility Name

Third Affiliated Hospital of Third Military Medical University

City

ChongQing

ZIP/Postal Code

400042

Country

China

Facility Name

Fujian Cancer Hospital

City

Fuzhou

ZIP/Postal Code

350014

Country

China

Facility Name

Sun Yet-sen University Cancer Center

City

Guangzhou

ZIP/Postal Code

510060

Country

China

Facility Name

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

City

Hangzhou

ZIP/Postal Code

310016

Country

China

Facility Name

Harbin Medical University Cancer Hospital

City

Harbin

ZIP/Postal Code

150081

Country

China

Facility Name

Jiangsu Cancer Hospital

City

Nanjing

ZIP/Postal Code

210009

Country

China

Facility Name

The 81st Hospital of P.L.A.

City

Nanjing

Country

China

Facility Name

Affiliated Hospital of Nantong University

City

Nantong

ZIP/Postal Code

226001

Country

China

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Zhongshan Hospital Fudan University

City

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Shanghai First People's Hospital

City

Shanghai

ZIP/Postal Code

200080

Country

China

Facility Name

General Hospital of Shenyang Military Command of PLA

City

Shenyang

ZIP/Postal Code

110016

Country

China

Facility Name

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

City

Wuhan

ZIP/Postal Code

430023

Country

China

Facility Name

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

City

Xi'an

ZIP/Postal Code

710061

Country

China

Facility Name

The Affiliated Hospital of Xuzhou Medical College

City

Xuzhou

ZIP/Postal Code

221004

Country

China

Facility Name

Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Fakultni nemocnice Olomouc; Onkologicka klinika

City

Olomouc

ZIP/Postal Code

779 00

Country

Czechia

Facility Name

Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

City

Praha 2

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni

City

Praha 5

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

Tampere University Hospital; Dept of Oncology

City

Tampere

ZIP/Postal Code

33520

Country

Finland

Facility Name

Hopital Augustin Morvan; Federation De Cancerologie

City

Brest

ZIP/Postal Code

29200

Country

France

Facility Name

Hopital Beaujon; Gastro Enterologie 1

City

Clichy

ZIP/Postal Code

92118

Country

France

Facility Name

Centre Val Aurelle Paul Lamarque; Medecine A1 A2

City

Montpellier

ZIP/Postal Code

34298

Country

France

Facility Name

Hopital Saint Antoine; Hepatologie-Gastr-Enterologie

City

Paris

ZIP/Postal Code

75571

Country

France

Facility Name

Hop Europeen Georges Pompidou; Gastro Enterologie

City

Paris

ZIP/Postal Code

75908

Country

France

Facility Name

Hopital Robert Debre; Gastro Enterologie

City

Reims

ZIP/Postal Code

51092

Country

France

Facility Name

Hopital Purpan; Unite Onco Digestive

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

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

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

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

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Facharztzentrum Eppendorf, Studien GbR

City

Hamburg

ZIP/Postal Code

20249

Country

Germany

Facility Name

Universitätsklinikum Köln

City

Köln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Tagesklinik Landshut; Hämatologie/Onkologie

City

Landshut

ZIP/Postal Code

84028

Country

Germany

Facility Name

Onkologische Gemeinschaftspraxis

City

Magdeburg

ZIP/Postal Code

39104

Country

Germany

Facility Name

Grupo Angeles

City

Guatemala City

ZIP/Postal Code

01015

Country

Guatemala

Facility Name

Centro Oncológico Sixtino / Centro Oncológico SA

City

Guatemala

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X

City

Budapest

ZIP/Postal Code

1097

Country

Hungary

Facility Name

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

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Hetenyi Geza County Hospital; Onkologiai Kozpont

City

Szolnok

ZIP/Postal Code

5004

Country

Hungary

Facility Name

Zala Megyei Kórház, Külsö Kórház, Pózva; Onkológiai Osztály

City

Zalaegerszeg

ZIP/Postal Code

8900

Country

Hungary

Facility Name

Campus Universitario S.Venuta; Centro Oncologico T.Campanella

City

Catanzaro

State/Province

Calabria

ZIP/Postal Code

88100

Country

Italy

Facility Name

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

City

Bologna

State/Province

Emilia-Romagna

ZIP/Postal Code

40138

Country

Italy

Facility Name

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

City

Torino

State/Province

Piemonte

ZIP/Postal Code

10126

Country

Italy

Facility Name

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

City

Firenze

State/Province

Toscana

ZIP/Postal Code

50139

Country

Italy

Facility Name

A.O. Universitaria Pisana; Oncologia

City

Pisa

State/Province

Toscana

ZIP/Postal Code

56100

Country

Italy

Facility Name

Aichi Cancer Center Hospital; Clinical Oncology

City

Aichi

ZIP/Postal Code

464-8681

Country

Japan

Facility Name

Chiba Cancer Center; Gastroenterology

City

Chiba

ZIP/Postal Code

260-8717

Country

Japan

Facility Name

National Cancer Center Hospital East; Gastroenterology

City

Chiba

ZIP/Postal Code

277-8577

Country

Japan

Facility Name

National Hospital Organization Shikoku Cancer Center; Gastroenterology

City

Ehime

ZIP/Postal Code

791-0280

Country

Japan

Facility Name

Hokkaido University Hospital：Gastroenterology

City

Hokkaido

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

Hyogo College Of Medicine; Upper Gastroenterology

City

Hyogo

ZIP/Postal Code

663-8501

Country

Japan

Facility Name

Hyogo Cancer Center; Gastroenterology

City

Hyogo

ZIP/Postal Code

673-8558

Country

Japan

Facility Name

Ibaraki Prefectural Central Hospital; Gastroenterology

City

Ibaraki

ZIP/Postal Code

309-1793

Country

Japan

Facility Name

Tohoku Uni Hospital; Clinical Oncology

City

Miyagi

ZIP/Postal Code

980-8574

Country

Japan

Facility Name

Osaka University Hospital; Surgery

City

Osaka

ZIP/Postal Code

565-0871

Country

Japan

Facility Name

Kindai University Hospital; Medical Oncology

City

Osaka

ZIP/Postal Code

589-8511

Country

Japan

Facility Name

Saitama Cancer Center; Gastroenterology

City

Saitama

ZIP/Postal Code

362-0806

Country

Japan

Facility Name

Shizuoka Cancer Center; Gastroenterology

City

Shizuoka

ZIP/Postal Code

411-8777

Country

Japan

Facility Name

Shizuoka General Hospital; Clinical Oncology

City

Shizuoka

ZIP/Postal Code

420-8527

Country

Japan

Facility Name

Tochigi Cancer Center; Medical Oncology

City

Tochigi

ZIP/Postal Code

320-0834

Country

Japan

Facility Name

National Cancer Center Hospital; Gastrointestinal Oncology

City

Tokyo

ZIP/Postal Code

104-0045

Country

Japan

Facility Name

Toranomon Hospital; Medical Oncology

City

Tokyo

ZIP/Postal Code

105-8470

Country

Japan

Facility Name

Tokyo Metropolitan Komagome Hospital; Chemotherapy

City

Tokyo

ZIP/Postal Code

113-8677

Country

Japan

Facility Name

The Cancer Institute Hospital, JFCR; Gastroenterology

City

Tokyo

ZIP/Postal Code

135-8550

Country

Japan

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Asan Medical Center; Medical Oncology

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Yonsei University Severance Hospital; Medical Oncology

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

Korea University Anam Hospital; Oncology Haemotology

City

Seoul

ZIP/Postal Code

136-705

Country

Korea, Republic of

Facility Name

Seoul St.Mary's Hospital; Medical Oncology

City

Seoul

ZIP/Postal Code

137-807

Country

Korea, Republic of

Facility Name

University Malaya Medical Centre; Clinical Oncology Unit,

City

Kuala Lumpur

ZIP/Postal Code

59100

Country

Malaysia

Facility Name

Hospital Wanita dan Kanak-Kanak Sabah

City

Sabah

ZIP/Postal Code

88996

Country

Malaysia

Facility Name

Centenario Hospital Miguel Hidalgo

City

Aguascalientes

ZIP/Postal Code

20230

Country

Mexico

Facility Name

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

City

Chihuahua

ZIP/Postal Code

31000

Country

Mexico

Facility Name

Hospital General de México; Unidad de Oncologia

City

Mexico DF

ZIP/Postal Code

06726

Country

Mexico

Facility Name

Centro Hemato Oncologico Paitilla

City

Panama City

ZIP/Postal Code

083200752

Country

Panama

Facility Name

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

City

Chiclayo

ZIP/Postal Code

CIX

Country

Peru

Facility Name

Hospital Nacional Adolfo Guevara Velasco

City

Cusco

ZIP/Postal Code

08006

Country

Peru

Facility Name

Hospital Nacional Edgardo Rebagliati Martins

City

Jesus Maria

ZIP/Postal Code

Lima 11

Country

Peru

Facility Name

Instituto Nacional de Enfermedades Neoplasicas

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Perpetual Succour Hospital

City

Cebu

ZIP/Postal Code

6000

Country

Philippines

Facility Name

Veterans Memorial Medical Ctr; Cancer Research Centre

City

Quezon City, Luzon

ZIP/Postal Code

1101

Country

Philippines

Facility Name

Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Szpital Uniwersytecki w Krakowie

City

Krakow

ZIP/Postal Code

31-501

Country

Poland

Facility Name

Wielkopolskie Centrum Onkologii; im. Marii Skłodowskiej-Curie

City

Poznan

ZIP/Postal Code

61-866

Country

Poland

Facility Name

Wojewódzki Szpital Specjalistyczny Nr 3

City

Rybnik

ZIP/Postal Code

44-200

Country

Poland

Facility Name

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

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Institutul Clinic Fundeni Bucuresti

City

Bucharest

ZIP/Postal Code

022328

Country

Romania

Facility Name

Spitalul Universitar CF Cluj-Napoca; Sectia Oncologie

City

Cluj-Napoca

ZIP/Postal Code

400015

Country

Romania

Facility Name

Medisprof SRL

City

Cluj-Napoca

ZIP/Postal Code

400058

Country

Romania

Facility Name

Spitalul Clinic Judetean Mures; Oncologie Medicala

City

Targu Mures

ZIP/Postal Code

540141

Country

Romania

Facility Name

Arkhangelsk Regional Clinical Oncology Dispensary

City

Arkhangelsk

ZIP/Postal Code

163045

Country

Russian Federation

Facility Name

Ivanovo Regional Oncology Dispensary

City

Ivanovo

ZIP/Postal Code

153040

Country

Russian Federation

Facility Name

Omsk Region Clinical Oncology Dispensary; 1St Sergical Department

City

Omsk

ZIP/Postal Code

644013

Country

Russian Federation

Facility Name

State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary

City

Pyatigorsk

ZIP/Postal Code

357502

Country

Russian Federation

Facility Name

Tula Regional Oncology Dispensary

City

Tula

ZIP/Postal Code

300053

Country

Russian Federation

Facility Name

National Cancer Centre

City

Singapore

ZIP/Postal Code

169610

Country

Singapore

Facility Name

Hospital Univ. Central de Asturias; Servicio de Oncologia

City

Oviedo

State/Province

Asturias

ZIP/Postal Code

33011

Country

Spain

Facility Name

Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

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

City

Santiago de Compostela

State/Province

La Coruña

ZIP/Postal Code

15706

Country

Spain

Facility Name

Hospital Clinic i Provincial; Servicio de Farmacia

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Hospital Universitario La Paz; Servicio de Oncologia

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Hospital Universitario Virgen del Rocio; Servicio de Oncologia

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Hospital Universitario Miguel Servet; Servicio Oncologia

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Kaohsiung Chang Gung Memorial Hospital; Dept of Hem and Onc

City

Kaohsung

ZIP/Postal Code

883

Country

Taiwan

Facility Name

National Taiwan Uni Hospital; Dept of Oncology

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

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

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department

City

Erzurum

ZIP/Postal Code

25240

Country

Turkey

Facility Name

Istanbul Bilim University School Of Medicine; Department Of Medical Oncology

City

Istanbul

ZIP/Postal Code

34300

Country

Turkey

Facility Name

Marmara Uni Faculty of Medicine; Medical Oncology

City

Istanbul

ZIP/Postal Code

34890

Country

Turkey

Facility Name

Ege Uni Medical Faculty; Oncology Dept

City

Izmir

ZIP/Postal Code

35100

Country

Turkey

Facility Name

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

City

Sıhhiye, ANKARA

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Velindre Cancer Centre; Oncology Dept

City

Cardiff

ZIP/Postal Code

CF14 2TL

Country

United Kingdom

Facility Name

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

City

Glasgow

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Facility Name

Royal Marsden Hospital; Dept of Med-Onc

City

London

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Facility Name

Christie Hospital Nhs Trust; Medical Oncology

City

Manchester

ZIP/Postal Code

M2O 4BX

Country

United Kingdom

Facility Name

Royal Marsden Hospital; Dept of Medical Oncology

City

Sutton

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Facility Name

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

City

Weston Super Mare

ZIP/Postal Code

BS23 4TQ

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

30706247

Citation

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.

Results Reference

derived

PubMed Identifier

28343975

Citation

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.

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

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