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A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastroesophageal Junction or Gastric Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01774786
First received: January 21, 2013
Last updated: May 10, 2017
Last verified: May 2017
  Purpose
This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab, fluoropyrimidine and cisplatin as first-line treatment in participants with HER2-positive metastatic gastroesophageal junction (GEJ) or gastric cancer (GC). Participants will be randomized to receive pertuzumab 840 milligrams (mg) or placebo intravenously every 3 weeks (q3w) in combination with trastuzumab (initial dose of 8 milligrams per kilogram [mg/kg] intravenously [IV] followed by 6 mg/kg IV q3w) and cisplatin and fluoropyrimidine (capecitabine or 5-fluorouracil) for the first 6 treatment cycles. Participants will continue to receive pertuzumab or placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.

Condition Intervention Phase
Gastric Cancer Drug: 5-Fluorouracil Drug: Capecitabine Drug: Cisplatin Drug: Pertuzumab Drug: Placebo Drug: Trastuzumab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Baseline up to death (up to approximately 8.5 years) ]

Secondary Outcome Measures:
  • Progression-Free Survival, as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Criteria [ Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 8.5 years) ]
  • Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria [ Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 8.5 years) ]
  • Duration of Objective Response, as Determined by Investigator According to RECIST v1.1 Criteria [ Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 8.5 years) ]
  • Percentage of Participants With Clinical Benefit, as Determined by the Investigator According to RECIST v1.1 Criteria [ Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 8.5 years) ]
  • Percentage of Participants With Adverse Events [ Time Frame: Baseline up to approximately 8.5 years ]
  • Percentage of Participants With Left Ventricular Systolic Dysfunction (Symptomatic or Asymptomatic) [ Time Frame: Baseline up to approximately 8.5 years ]
  • European Organization for Research and Treatment of Cancer (EORTC) Quality of Life-Core 30 (QLQ-C30) Questionnaire Score [ Time Frame: Day 1 of each 21-day treatment cycle up to 28 and 60-90 days after Day 1 of last treatment cycle (up to approximately 8.5 years) ]
  • EORTC QLQ-Gastric Cancer Module (EORTC QCQ-STO22) Questionnaire Score [ Time Frame: Day 1 of each 21-day treatment cycle up to 28 and 60-90 days after Day 1 of last treatment cycle (up to approximately 8.5 years) ]
  • European Quality of Life - 5 Dimensions (EQ-5D) Questionnaire Score [ Time Frame: Day 1 of each 21-day treatment cycle up to 28 and 60-90 days after Day 1 of last treatment cycle (up to approximately 8.5 years) ]
  • Maximum Serum Concentrations (Cmax) of Pertuzumab\n [ Time Frame: Pre-dose (0-6 hours [Hr] before infusion) on Day 1 (D1) of Cycles (Cy) 1, 2, 3, 4, 6, 8; 0.5 Hr after end of 30-60 minutes infusion on D1 of Cy 1, 2, 4, 8; at 28 & 60-90 days after D1 of last Cy (up to approximately 8.5 years) (1 cycle = 21 days) ]
  • Cmax of Trastuzumab [ Time Frame: Pre-dose (0-6 hours [Hr] before infusion) on Day 1 (D1) of Cycles (Cy) 1, 2, 3, 4, 6, 8; 0.5 Hr after end of 30-60 minutes infusion on D1 of Cy 1, 2, 4, 8; at 28 & 60-90 days after D1 of last Cy (up to approximately 8.5 years) (1 cycle = 21 days) ]
  • Minimum Serum Concentration (Cmin) of Pertuzumab [ Time Frame: Pre-dose (0-6 Hr before infusion) on D1 of Cy 1, 2, 3, 4, 6, 8; at 28 & 60-90 days after D1 of last Cy (up to approximately 8.5 years) (1 cycle = 21 days) ]
  • Cmin of Trastuzumab [ Time Frame: Pre-dose (0-6 Hr before infusion) on D1 of Cy 1, 2, 3, 4, 6, 8; at 28 & 60-90 days after D1 of last Cy (up to approximately 8.5 years) (1 cycle = 21 days) ]
  • Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Pertuzumab [ Time Frame: Pre-dose (0-6 Hr before infusion) on Day 1 of Cycles 1, 3, 6; at 28 & 60-90 days after D1 of last Cy (up to approximately 8.5 years) (1 cycle = 21 days) ]

Enrollment: 780
Actual Study Start Date: June 10, 2013
Estimated Study Completion Date: December 15, 2021
Primary Completion Date: December 9, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pertuzumab + Trastuzumab + Chemotherapy
\nParticipants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Drug: 5-Fluorouracil
Participants will receive 5-fluorouracil 800 milligrams per meter square (mg/m^2)/24 hour IV infusion for 120 hours (Days 1-5) q3w for 6 cycles.
Drug: Capecitabine
Participants will receive capecitabine 1000 mg/m^2 orally twice daily, evening of Day 1 to morning of Day 15 (28 doses) q3w for 6 cycles.
Drug: Cisplatin
Participants will receive cisplatin 80 mg/m^2 IV q3w for 6 cycles.
Drug: Pertuzumab
Participants will receive pertuzumab 840 mg IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Other Name: Perjeta
Drug: Placebo
Participants will receive pertuzumab placebo IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Drug: Trastuzumab
Participants will receive 8 mg/kg IV initial dose on Day 1, followed by 6 mg/kg IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Other Name: Herceptin
Placebo Comparator: Placebo + Trastuzumab + Chemotherapy
Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Drug: 5-Fluorouracil
Participants will receive 5-fluorouracil 800 milligrams per meter square (mg/m^2)/24 hour IV infusion for 120 hours (Days 1-5) q3w for 6 cycles.
Drug: Capecitabine
Participants will receive capecitabine 1000 mg/m^2 orally twice daily, evening of Day 1 to morning of Day 15 (28 doses) q3w for 6 cycles.
Drug: Cisplatin
Participants will receive cisplatin 80 mg/m^2 IV q3w for 6 cycles.
Drug: Pertuzumab
Participants will receive pertuzumab 840 mg IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Other Name: Perjeta
Drug: Placebo
Participants will receive pertuzumab placebo IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Drug: Trastuzumab
Participants will receive 8 mg/kg IV initial dose on Day 1, followed by 6 mg/kg IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Other Name: Herceptin

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed metastatic adenocarcinoma of the stomach or GEJ
  • Measurable or evaluable non-measurable disease as assessed by the investigator according to RECIST v1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Life expectancy greater than equal to (>/=) 3 months

Exclusion Criteria:

  • Previous cytotoxic chemotherapy for advanced (metastatic) disease
  • Evidence of disease progression documented within 6 months after completion of prior neoadjuvant or adjuvant cytotoxic chemotherapy, or both, or radiotherapy for GEJ adenocarcinoma
  • Previous treatment with any HER2-directed therapy, at any time, for any duration
  • Previous exposure to any investigational treatment within 30 days before the first dose of study treatment
  • Radiotherapy within 30 days before the first dose of study treatment (within 2 weeks if given as palliation to bone metastases, if recovered from all toxicities)
  • History or evidence of brain metastases
  • Clinically significant active gastrointestinal (GI) bleeding (Grade >/=2 according to National Cancer Institute [NIC]-Common Terminology Criteria for Adverse Events Version 4.0 [CTCAEv.4.0])
  • Residual toxicity resulting from previous therapy (for example, hematologic, cardiovascular, or neurologic toxicity that is Grade >/=2). Alopecia is permitted
  • Other malignancy (in addition to gastric cancer [GC]) within 5 years before enrollment, except for carcinoma in situ of the cervix or squamous or basal cell carcinoma of the skin that has been previously treated with curative intent
  • Inadequate hematologic, renal or liver function
  • Pregnant or lactating women
  • History of congestive heart failure of any New York Heart Association (NYHA) criteria
  • Angina pectoris requiring treatment
  • Myocardial infarction within the past 6 months before the first dose of study drug
  • Clinically significant valvular heart disease or uncontrollable high-risk cardiac arrhythmia
  • History or evidence of poorly controlled hypertension
  • Baseline left ventricular ejection fraction (LVEF) value less than (<) 55 percent (%)
  • Any significant uncontrolled intercurrent systemic illness
  • Positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
  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: NCT01774786

  Hide Study Locations
Locations
United States, California
Stanford Cancer Center
Stanford, California, United States, 94305-5820
United States, Colorado
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, United States, 80218
United States, Florida
Florida Cancer Specialists - SCRI; Pharmacy
Fort Myers, Florida, United States, 33901
Cancer Institute of Florida PA
Orlando, Florida, United States, 32804
Florida Cancer Specialists.
Saint Petersburg, Florida, United States, 33705
United States, Illinois
University Of Chicago Medical Center; Section Of Hematology/Oncology
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University Health; Goshen Center for Cancer Care
Goshen, Indiana, United States, 46526
United States, Minnesota
Minnesota Oncology Hematology, Pa
Minneapolis, Minnesota, United States, 55407
United States, Nevada
Comprehensive Cancer Centers of Nevada - Eastern Avenue
Las Vegas, Nevada, United States, 89169
United States, New York
New York Oncology Hematology, P.C.
Albany, New York, United States, 12206
Queens Medical Associates
Fresh Meadows, New York, United States, 11366
Weill Medical College of Cornell University; Division of Hematology & Medical Oncology
New York, New York, United States, 10065
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States, 45219
United States, South Carolina
Medical University of South Carolina; Hollings Cancer Center
Charleston, South Carolina, United States, 29425
United States, Tennessee
Tennessee Oncology PLLC - Nashville (20th Ave)
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology - Lake Vista
Lewisville, Texas, United States, 75067
Texas Oncology - Paris
Paris, Texas, United States, 75460
Texas Oncology, P.A. - Tyler; Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Virginia
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
United States, Washington
Puget Sound Cancer Centers
Edmonds, Washington, United States, 98026
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Australia, Queensland
Royal Brisbane Womens Hosp; Division of Oncology
Herston, Queensland, Australia, 4029
Australia, Victoria
Monash Medical Centre; Oncology
East Bentleigh, Victoria, Australia, VIC 3165
Austin Health; Cancer Clinical Trial Centre
Heidelberg, Victoria, Australia, 3084
Australia, Western Australia
Sir Charles Gairdner Hospital; Medical Oncology
Perth, Western Australia, Australia, 6009
Austria
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Salzburg, Austria, 5020
Krankenhaus St. Vinzenz Der Barmherzigen Schwestern Zams; Abt. Für Innere Medizin
Zams, Austria, 6511
Belgium
Cliniques Universitaires St-Luc
Bruxelles, Belgium, 1200
Brazil
Clinicas Oncologicas Integradas - COI
Rio de Janeiro, RJ, Brazil, 22793-080
Hospital das Clinicas - UFRGS
Porto Alegre, RS, Brazil, 90035-003
Hospital Nossa Senhora da Conceicao
Porto Alegre, RS, Brazil, 91350-200
Centro de Pesquisas Oncologicas - CEPON
Florianopolis, SC, Brazil, 88034-000
Hospital Sirio Libanes; Centro de Oncologia
Sao Paulo, SP, Brazil, 01308-050
Clinica de Oncologia Medica
Sao Paulo, SP, Brazil, 01406100
Hospital A. C. Camargo; Oncologia
Sao Paulo, SP, Brazil, 01509-010
Universidade Federal de Sao Paulo - UNIFESP
Sao Paulo, SP, Brazil, 22793-080
Bulgaria
Complex Oncological Center - Plovdiv, EOOD
Plovdiv, Bulgaria, 4004
MHAT Serdika
Sofia, Bulgaria, 1301
Military Medical Academy- MHAT
Sofia, Bulgaria, 1606
SHATOD Dr. Marko Antonov Markov-Varna, EOOD; Department of Medicinall Onchotherapy and Palliative
Varna, Bulgaria, 9010
Canada, Newfoundland and Labrador
Dr. H. Bliss Murphy Cancer Centre; Oncology
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
Hamilton Health Sciences - Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Northeast Cancer Centre of Health Sciences North
Sudbury, Ontario, Canada, P3E 5J1
Toronto East General Hospital; Haematology/Oncology
Toronto, Ontario, Canada, M4C 3E7
Sunnybrook Health Science Centre
Toronto, Ontario, Canada, M4N 3M5
Mount Sinai Hospital; Oncology
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
McGill University; Glen Site; Oncology
Montreal, Quebec, Canada, H4A 3J1
China
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, China, 100021
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
Fuzhou General Hospital, PLA Nanjing Military Area Command
Fuzhou, China, 110016
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
The 1st Affiliated Hospital of Nanchang Unversity
Nanchang, China, 330006
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
General Hospital of Shenyang Military Command of PLA
Shenyang, China, 110016
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
Shijiazhuang, China, 050035
The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)
Xi'an, China, 710032
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, China, 221004
Henan Cancer Hospital
Zhengzhou, China, 450008
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China, 450052
Croatia
Clinical Hospital Centre Osijek
Osijek, Croatia, 31000
Clinical Hospital Centre Zagreb
Zagreb, Croatia, 10000
Clinical Hospital Sisters of Mercy
Zagreb, Croatia, 10000
El Salvador
Hospital Oncologia; Oncology
Salvador, El Salvador, 01101
Finland
Docrates Cance Center
Helsinki, Finland, 00180
Turku Uni Central Hospital; Oncology Clinics
Turku, Finland, 20520
Germany
Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.
Berlin, Germany, 10117
Universitaetsklinikum Essen, Innere Klinik und Poliklinik fuer Tumorforschung
Essen, Germany, 45122
Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Internistische Onkologie / Haematologie
Essen, Germany, 45136
Klinik Esslingen; Klinik für Allgemeine Innere Medizin, Onkologie/Haematologie
Esslingen, Germany, 73730
Universitätsklinikum Hamburg-Eppendorf; Hubertus Wald Tumorzentrum
Hamburg, Germany, 20246
Universitaetsklinikum Leipzig, Universitaeres Krebszentrum Leipzig (UCCL)
Leipzig, Germany, 04103
Klinikum Ludwigsburg; Studiensekretariat
Ludwigsburg, Germany, 71640
Uniklinik Mainz; Ii. Medizinische Klinik
Mainz, Germany, 55131
Universitätsklinikum Mannheim, Tagestherapiezentrum, Interdisziplinäres Tumorzentrum
Mannheim, Germany, 68167
Philipps-Universität Marburg; Klinik für Innere Med.; Schwerpunkt Hämatologie/Onkologie/Immunologie
Marburg, Germany, 35043
Universitätsklinikum Ulm; Zentrum für Innere Medizin Klinik für Innere Medizin I
Ulm, Germany, 89081
Guatemala
Medical Solution; Hematology
Guatemala, Guatemala, 01-010
Hungary
Semmelweis Egyetem Onkologiai Központ
Budapest, Hungary, 1083
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
Budapest, Hungary, 1122
Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika
Debrecen, Hungary, 4032
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz;Sugarterapias Klinikai Onkologiai Intez
Miskolc, Hungary, 3526
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
Szeged, Hungary, 6720
Italy
Campus Universitario S.Venuta; Centro Oncologico T.Campanella
Catanzaro, Calabria, Italy, 88100
Seconda Universita' Degli Studi; Divsione Di Oncologia Medica
Napoli, Campania, Italy, 80131
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
Bologna, Emilia-Romagna, Italy, 40138
AO Santa Maria Nuova; U.O. Day Hospital di Oncologi
Reggio Emilia, Emilia-Romagna, Italy, 42100
Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
Udine, Friuli-Venezia Giulia, Italy, 33100
Policlinico Universitario Agostino Gemelli
Roma, Lazio, Italy, 00168
Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical
Genova, Liguria, Italy, 16132
Asst Papa Giovanni XXIII; Oncologia Medica
Bergamo, Lombardia, Italy, 24128
Irccs Ospedale San Raffaele
Milano, Lombardia, Italy, 20132
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
Milano, Lombardia, Italy, 20141
Ospedali Riuniti Di Ancona; Oncology
Ancona, Marche, Italy, 60121
IRCCS Ospedale Casa Sollievo Della Sofferenza
San Giovanni Rotondo, Puglia, Italy, 71013
Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2
Pisa, Toscana, Italy, 56100
Ospedale Misericordia E Dolce; Oncologia Medica
Prato, Toscana, Italy, 59100
Japan
Aichi Cancer Center Hospital; Clinical Oncology
Aichi, Japan, 464-8681
Nagoya university Hospital; Gastroenterological Surgery 2
Aichi, Japan, 466-8560
National Cancer Center Hospital East; Gastroenterology
Chiba, Japan, 277-8577
National Hospital Organization Shikoku Cancer Center; Gastroenterology
Ehime, Japan, 791-0280
Kyushu University Hospital; Surgery and Science
Fukuoka, Japan, 812-8582
Gifu University Hospital; Second Department of Surgery
Gifu, Japan, 501-1194
Hiroshima City Hiroshima Citizens Hospital; Surgery
Hiroshima, Japan, 730-8518
Kobe city Medical center General Hospital; Medical Oncology
Hyogo, Japan, 650-0047
St.Marianna University School of Medicine hospital; Medical Oncology
Kanagawa, Japan, 216-8511
Kanagawa Cancer Center; Gastrointestinal Surgery
Kanagawa, Japan, 241-8515
Osaka International Cancer Institute;; Medical oncology and Gastrointestinal oncology
Osaka, Japan, 541-8567
Osaka General Medical Center; Gastroenterological Surgery
Osaka, Japan, 558-8558
Saitama Cancer Center; Gastroenterology
Saitama, Japan, 362-0806
National Cancer Center Hospital; Gastrointestinal Oncology
Tokyo, Japan, 104-0045
Toyama University Hospital;Gastroenterology and Hematology
Toyama, Japan, 930-0194
Kazakhstan
Kazakh Scientific Research Institution Of Oncology and Radiology; Chemotherapy department
Almaty, Kazakhstan, 050022
Almaty Cancer Hospital; Chemotherapy department
Almaty, Kazakhstan, 050060
Korea, Republic of
Kyungpook National University Medical Center
Daegu, Korea, Republic of, 41404
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
Seoul, Korea, Republic of, 03080
Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology
Seoul, Korea, Republic of, 03722
Asan Medical Center; Medical Oncology
Seoul, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Seoul St Mary's Hospital
Seoul, Korea, Republic of, 06591
Macedonia, The Former Yugoslav Republic of
Clinical Hospital; Oncology Department
Bitola, Macedonia, The Former Yugoslav Republic of, 7000
University Clinic for Radiotherapy and Oncology
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Malaysia
Hospital Universiti Sains Malaysia
Kota Bharu Kelantan, Malaysia, 16150
Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi
Kuala Lumpur, Malaysia, 50586
University Malaya Medical Centre; Clinical Oncology Unit,
Kuala Lumpur, Malaysia, 59100
Hospital Wanita dan Kanak-Kanak Sabah
Sabah, Malaysia, 88996
Mexico
Hospital Angeles Metropolitano; Room 220
Mexico City, Mexico, 06760
Inst. Nacional de Cancerologia; Investigacion Clinica
Mexico City, Mexico, 14000
Oaxaca Site Management Organization
Oaxaca, Mexico, 68000
Netherlands
Academisch Medisch Centrum Universiteit Amsterdam
Amsterdam, Netherlands, 1105 AZ
Panama
Medical Research Centre
Panama, Panama
Peru
Centro Medico Monte Carmelo
Arequipa, Peru, 04001
Hospital Sabogal; Oncology
Callao, Peru, 02
Hosp Nacion Edgardo Rebagliati; Oncologia Medica
Jesus Maria, Peru, Lima 11
Clinica San Borja
Lima, Peru, Lima 41
Instituto Oncologico Miraflore
Miraflores, Peru, Lima 18
Poland
Bialostockie Ctr Onkologii; Oddzial Chemioterapii Dziennej
Bialystok, Poland, 15-027
Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny
Brzozów, Poland, 36-200
Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
Bydgoszcz, Poland, 85-796
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
Krakow, Poland, 31-531
SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego
Opole, Poland, 45-060
NZOZ Centrum Medyczne HCP Sp. z o.o.
Poznan, Poland, 61-485
Wojewódzki Szpital Specjalistyczny Nr 3
Rybnik, Poland, 44-200
Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie; Klinika Gastroenterologii Onkologicznej
Warszawa, Poland, 02-781
Dolnoslaskie Centrum Onkologii
Wroclaw, Poland, 53-439
Romania
Institut Oncologic Prof. Dr. Alexandru Trestioreanu; Departament Radioterapie
Bucharest, Romania, 022328
Cardiomed Medical Center
Cluj-Napoca, Romania, 400015
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca; Spital de zi-Parter
Cluj-Napoca, Romania, 400015
Oncology Center Sf. Nectarie
Craiova, Romania, 200347
Euroclinic Center of Oncology SRL
Iasi, Romania, 700106
Russian Federation
Clinical Oncology Dispensary of Ministry of Health of Tatarstan
Kazan, Russian Federation, 420029
Clinical Oncology Dispensary; Chemotherapy
Omsk, Russian Federation, 644013
FSI Rostov research oncological institute of MoH and SD of RF; PAD
Rostov-on-Don, Russian Federation, 344037
SBI for HPE "Ryazan State Medical University n.a. I.P. Pavlov" of MoH of RF
Ryazan, Russian Federation, 390011
SBI of Healthcare Samara Regional Clinical Oncology Dispensary
Samara, Russian Federation, 443031
Spain
Hospital General Universitario de Elche; Servicio de Oncologia
Elche, Alicante, Spain, 03203
Hospital del Mar; Servicio de Oncologia
Barcelona, Spain, 08003
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, Spain, 08035
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona, Spain, 08041
Hospital Duran i Reynals; Oncologia
Barcelona, Spain, 08907
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Barcelona, Spain, 08916
Hospital Universitario Reina Sofia; Servicio de Oncologia
Cordoba, Spain, 14004
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, Spain, 28034
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, Spain, 28041
Switzerland
CHUV; Departement d'Oncologie
Lausanne, Switzerland, 1011
Luzerner Kantonsspital; Medizinische Onkologie
Luzern, Switzerland, 6004
Stadtspital Triemli; Klinik für medizinische Onkologie und Hämatologie
Zürich, Switzerland, 8063
Taiwan
Taichung Veterans General Hospital; Dept of Surgery
Taichung, Taiwan, 407
National Cheng Kung Unversity Hospital; Oncology
Tainan, Taiwan, 00704
Taipei Veterans General Hospital
Taipei, Taiwan, 00112
National Taiwan Uni Hospital; Dept of Oncology
Taipei, Taiwan, 100
Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
Taoyuan, Taiwan, 333
Thailand
Rajavithi Hospital; Division of Medical Oncology
Bangkok, Thailand, 10400
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
Bangkok, Thailand, 10400
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok, Thailand, 10700
Khonkaen Hospital
Khonkaen, Thailand, 40000
King Chulalongkorn Memorial Hospital; Faculty of Medicine Chulalongkorn University
Patumwan, Thailand, 10330
Prince of Songkla Uni ; Unit of Medical Oncology
Songkhla, Thailand, 90110
Turkey
Ankara Uni School of Medicine; Medical Oncology
Ankara, Turkey, 06590
Akdeniz University Medical Faculty; Medical Oncology Department
Antalya, Turkey, 07070
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
Edirne, Turkey, 22770
Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
Erzurum, Turkey, 25240
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
Istanbul, Turkey, 34300
TC Necmettin Erbakan University Meram Medical Faculty Hospital
Konya, Turkey, 42080
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
Malatya, Turkey, 44280
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01774786     History of Changes
Other Study ID Numbers: BO25114
2012-003554-83 ( EudraCT Number )
Study First Received: January 21, 2013
Last Updated: May 10, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Fluorouracil
Pertuzumab
Cisplatin
Trastuzumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017