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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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01641939
First received: July 13, 2012
Last updated: May 5, 2017
Last verified: May 2017
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Drug: Taxane
Drug: trastuzumab emtansine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall Survival (OS)- Phase 3 [ Time Frame: Date of randomization until death (up to 2 years 3 months) ]
    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) [ Time Frame: Date of randomization until death (up to 1 year) ]
    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.


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 [ 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) ]
    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 [ 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) ]
    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 [ 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) ]
    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 [ 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) ]
    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 [ 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) ]
    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 [ 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) ]
    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 [ 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) ]
    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 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) ]
    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 [ Time Frame: Day 1 (D1) of Cycle 1 (C1) and C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks) ]
    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 [ Time Frame: C1D1 and C1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks) ]
    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 [ Time Frame: C1D1; C4D1 ]
    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 [ Time Frame: D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks) ]
    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 [ Time Frame: D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks) ]
    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 [ Time Frame: D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks) ]
    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 [ Time Frame: D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks) ]
    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.


Enrollment: 415
Actual Study Start Date: September 3, 2012
Study Completion Date: April 30, 2016
Primary Completion Date: June 30, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard taxane therapy
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.
Drug: Taxane
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.
Experimental: trastuzumab emtansine 2.4 mg
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.
Drug: trastuzumab emtansine
trastuzumab emtansine 2.4 mg/kg IV once a week
Experimental: trastuzumab emtansine 3.6 mg
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.
Drug: trastuzumab emtansine
trastuzumab emtansine 3.6 mg/kg IV every 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01641939

  Hide Study Locations
Locations
United States, California
Comprehensive Blood/Cancer Ctr
Bakersfield, California, United States, 93309
Stanford University School of Medicine
Stanford, California, United States, 94305-5151
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06520
United States, Kansas
University of Kansas; Medical Center & Medical pavilion
Westwood, Kansas, United States, 66205
United States, Kentucky
Norton Healthcare Inc.
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Massachusetts General Hospital.
Boston, Massachusetts, United States, 02114
Dana Farber Can Ins
Boston, Massachusetts, United States, 02215
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
United States, Tennessee
Vanderbilt
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Argentina
Fundación Investigar
Buenos Aires, Argentina, 1025
Hospital de Gastroenterologia Dr. Bonorino Udaondo ; Servicio de Oncología
Buenos Aires, Argentina, C1264AAA
Instituto de Oncología de Rosario
Rosario, Argentina, S2000KZE
Belgium
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
Brazil
Instituto Nacional de Cancer - INCa; Oncologia
Rio de Janeiro, RJ, Brazil, 20560-120
Clinica de Oncologia de Porto Alegre - CliniOnco
Porto Alegre, RS, Brazil, 90430-090
Hospital Sao Lucas - PUCRS
Porto Alegre, RS, Brazil, 90610-000
Hospital de Cancer de Barretos
Barretos, SP, Brazil, 14784-400
Hospital Amaral Carvalho
Jau, SP, Brazil, 17210-080
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo, SP, Brazil, 01246-000
Instituto de Oncologia de Sorocaba - CEPOS
Sorocaba, SP, Brazil, 18030-245
Canada, British Columbia
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Brampton Memorial Hospital, William Osler Health Center
Brampton, Ontario, Canada, L6R 3J7
Toronto East General Hospital; Haematology/Oncology
Toronto, Ontario, Canada, M4C 3E7
St. Michael'S Hospital
Toronto, Ontario, Canada, M5B 1W8
China
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
Beijing, China, 100071
Beijing Cancer Hospital
Beijing, China, 100142
Jilin Cancer Hospital
Changchun, China, 130012
the First Hospital of Jilin University
Changchun, China, 130021
Changzhou First People's Hospital
Changzhou, China, 213003
Third Affiliated Hospital of Third Military Medical University
ChongQing, China, 400042
Fujian Cancer Hospital
Fuzhou, China, 350014
Sun Yet-sen University Cancer Center
Guangzhou, China, 510060
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, China, 310016
Harbin Medical University Cancer Hospital
Harbin, China, 150081
Jiangsu Cancer Hospital
Nanjing, China, 210009
The 81st Hospital of P.L.A.
Nanjing, China
Affiliated Hospital of Nantong University
Nantong, China, 226001
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Zhongshan Hospital Fudan University
Shanghai, China, 200032
Shanghai First People's Hospital
Shanghai, China, 200080
General Hospital of Shenyang Military Command of PLA
Shenyang, China, 110016
Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center
Wuhan, China, 430023
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, China, 710061
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, China, 221004
Czechia
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
Hradec Kralove, Czechia, 500 05
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, Czechia, 779 00
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
Praha 2, Czechia, 128 08
Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni
Praha 5, Czechia, 150 06
Finland
Tampere University Hospital; Dept of Oncology
Tampere, Finland, 33520
France
Hopital Augustin Morvan; Federation De Cancerologie
Brest, France, 29200
Hopital Beaujon; Gastro Enterologie 1
Clichy, France, 92118
Centre Val Aurelle Paul Lamarque; Medecine A1 A2
Montpellier, France, 34298
Hopital Saint Antoine; Hepatologie-Gastr-Enterologie
Paris, France, 75571
Hop Europeen Georges Pompidou; Gastro Enterologie
Paris, France, 75908
Hopital Robert Debre; Gastro Enterologie
Reims, France, 51092
Hopital Purpan; Unite Onco Digestive
Toulouse, France, 31059
Germany
Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.
Berlin, Germany, 10117
Universitätsklinikum "Carl Gustav Carus"; Med. Klinik & Poliklinik I, Arbeitsgr. intern. Onkologie
Dresden, Germany, 01307
Facharztzentrum Eppendorf, Studien GbR
Hamburg, Germany, 20249
Universitätsklinikum Köln
Köln, Germany, 50937
Tagesklinik Landshut; Hämatologie/Onkologie
Landshut, Germany, 84028
Onkologische Gemeinschaftspraxis
Magdeburg, Germany, 39104
Guatemala
Grupo Angeles
Guatemala City, Guatemala, 01015
Centro Oncológico Sixtino / Centro Oncológico SA
Guatemala, Guatemala, 01010
Hungary
Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X
Budapest, Hungary, 1097
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
Szeged, Hungary, 6720
Hetenyi Geza County Hospital; Onkologiai Kozpont
Szolnok, Hungary, 5004
Zala Megyei Kórház, Külsö Kórház, Pózva; Onkológiai Osztály
Zalaegerszeg, Hungary, 8900
Italy
Campus Universitario S.Venuta; Centro Oncologico T.Campanella
Catanzaro, Calabria, Italy, 88100
AZ.Osp S. Orsola - Malpighi-Reparto di Oncologia Medica
Bologna, Emilia-Romagna, Italy, 40138
A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica
Torino, Piemonte, Italy, 10126
Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
Firenze, Toscana, Italy, 50139
A.O. Universitaria Pisana; Oncologia
Pisa, Toscana, Italy, 56100
Japan
Aichi Cancer Center Hospital; Clinical Oncology
Aichi, Japan, 464-8681
Chiba Cancer Center; Gastroenterology
Chiba, Japan, 260-8717
National Cancer Center Hospital East; Gastroenterology
Chiba, Japan, 277-8577
National Hospital Organization Shikoku Cancer Center; Gastroenterology
Ehime, Japan, 791-0280
Hokkaido University Hospital:Gastroenterology
Hokkaido, Japan, 060-8648
Hyogo College Of Medicine; Upper Gastroenterology
Hyogo, Japan, 663-8501
Hyogo Cancer Center; Gastroenterology
Hyogo, Japan, 673-8558
Ibaraki Prefectural Central Hospital; Gastroenterology
Ibaraki, Japan, 309-1793
Tohoku Uni Hospital; Clinical Oncology
Miyagi, Japan, 980-8574
Osaka University Hospital; Surgery
Osaka, Japan, 565-0871
Kindai University Hospital; Medical Oncology
Osaka, Japan, 589-8511
Saitama Cancer Center; Gastroenterology
Saitama, Japan, 362-0806
Shizuoka Cancer Center; Gastroenterology
Shizuoka, Japan, 411-8777
Shizuoka General Hospital; Clinical Oncology
Shizuoka, Japan, 420-8527
Tochigi Cancer Center; Medical Oncology
Tochigi, Japan, 320-0834
National Cancer Center Hospital; Gastrointestinal Oncology
Tokyo, Japan, 104-0045
Toranomon Hospital; Medical Oncology
Tokyo, Japan, 105-8470
Tokyo Metropolitan Komagome Hospital; Chemotherapy
Tokyo, Japan, 113-8677
The Cancer Institute Hospital, JFCR; Gastroenterology
Tokyo, Japan, 135-8550
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Asan Medical Center; Medical Oncology
Seoul, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Yonsei University Severance Hospital; Medical Oncology
Seoul, Korea, Republic of, 120-752
Korea University Anam Hospital; Oncology Haemotology
Seoul, Korea, Republic of, 136-705
Seoul St.Mary's Hospital; Medical Oncology
Seoul, Korea, Republic of, 137-807
Malaysia
University Malaya Medical Centre; Clinical Oncology Unit,
Kuala Lumpur, Malaysia, 59100
Hospital Wanita dan Kanak-Kanak Sabah
Sabah, Malaysia, 88996
Mexico
Centenario Hospital Miguel Hidalgo
Aguascalientes, Mexico, 20230
Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre
Chihuahua, Mexico, 31000
Hospital General de México; Unidad de Oncologia
Mexico DF, Mexico, 06726
Panama
Centro Hemato Oncologico Paitilla
Panama City, Panama, 083200752
Peru
Hospital Nacional Almanzor Aguinaga Asenjo; Unidad De Investigacion Del Servicio De Oncologia Medica
Chiclayo, Peru, CIX
Hospital Nacional Adolfo Guevara Velasco
Cusco, Peru, 08006
Hospital Nacional Edgardo Rebagliati Martins
Jesus Maria, Peru, Lima 11
Instituto Nacional de Enfermedades Neoplasicas
Lima, Peru, 34
Philippines
Perpetual Succour Hospital
Cebu, Philippines, 6000
Veterans Memorial Medical Ctr; Cancer Research Centre
Quezon City, Luzon, Philippines, 1101
Poland
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gdansk, Poland, 80-952
Szpital Uniwersytecki w Krakowie
Krakow, Poland, 31-501
Wielkopolskie Centrum Onkologii; im. Marii Skłodowskiej-Curie
Poznan, Poland, 61-866
Wojewódzki Szpital Specjalistyczny Nr 3
Rybnik, Poland, 44-200
Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie; Klinika Gastroenterologii Onkologicznej
Warszawa, Poland, 02-781
Romania
Institutul Clinic Fundeni Bucuresti
Bucharest, Romania, 022328
Spitalul Universitar CF Cluj-Napoca; Sectia Oncologie
Cluj-Napoca, Romania, 400015
Medisprof SRL
Cluj-Napoca, Romania, 400058
Spitalul Clinic Judetean Mures; Oncologie Medicala
Targu Mures, Romania, 540141
Russian Federation
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk, Russian Federation, 163045
Ivanovo Regional Oncology Dispensary
Ivanovo, Russian Federation, 153040
Omsk Region Clinical Oncology Dispensary; 1St Sergical Department
Omsk, Russian Federation, 644013
State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary
Pyatigorsk, Russian Federation, 357502
Tula Regional Oncology Dispensary
Tula, Russian Federation, 300053
Singapore
National Cancer Centre
Singapore, Singapore, 169610
Spain
Hospital Univ. Central de Asturias; Servicio de Oncologia
Oviedo, Asturias, Spain, 33011
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
Santander, Cantabria, Spain, 39008
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
Santiago de Compostela, La Coruña, Spain, 15706
Hospital Clinic i Provincial; Servicio de Farmacia
Barcelona, Spain, 08036
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, Spain, 28007
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, Spain, 28046
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla, Spain, 41013
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, Spain, 50009
Taiwan
Kaohsiung Chang Gung Memorial Hospital; Dept of Hem and Onc
Kaohsung, Taiwan, 883
National Taiwan Uni Hospital; Dept of Oncology
Taipei, Taiwan, 100
Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
Taoyuan, Taiwan, 333
Turkey
Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
Erzurum, Turkey, 25240
Istanbul Bilim University School Of Medicine; Department Of Medical Oncology
Istanbul, Turkey, 34300
Marmara Uni Faculty of Medicine; Medical Oncology
Istanbul, Turkey, 34890
Ege Uni Medical Faculty; Oncology Dept
Izmir, Turkey, 35100
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Sıhhiye, ANKARA, Turkey, 06100
United Kingdom
Velindre Cancer Centre; Oncology Dept
Cardiff, United Kingdom, CF14 2TL
The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit
Glasgow, United Kingdom, G12 0YN
Royal Marsden Hospital; Dept of Med-Onc
London, United Kingdom, SW3 6JJ
Christie Hospital Nhs Trust; Medical Oncology
Manchester, United Kingdom, M2O 4BX
Royal Marsden Hospital; Dept of Medical Oncology
Sutton, United Kingdom, SM2 5PT
BRISTOL ONCOLOGY CENTRE; CLINICAL TRIALS UNIT; R & D department
Weston Super Mare, United Kingdom, BS23 4TQ
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01641939     History of Changes
Other Study ID Numbers: BO27952
2012-000660-22 ( EudraCT Number )
Study First Received: July 13, 2012
Results First Received: June 30, 2016
Last Updated: May 5, 2017

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Maytansine
Docetaxel
Ado-trastuzumab emtansine
Taxane
Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 25, 2017