AzTrials
AzTrials

Gastric CancerPhase 3JACOBNCT01774786

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

A Phase 3 study testing 5-Fluorouracil, Capecitabine and Cisplatin in people with Gastric Cancer, run by Hoffmann-La Roche at 172 sites in 32 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
5-Fluorouracil, Capecitabine and Cisplatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
780 participants
Where
172 sitesin 32 countries
Study dates
10 Jun 2013to 31 Dec 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

172 sites in 32 countries.

172 sites in 32 countries

China22 sites

  • Cancer Hospital Chinese Academy of Medical Sciences.

    Beijing, 100021

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

    Beijing, 100071

  • Beijing Cancer Hospital

    Beijing, 100142

  • the First Hospital of Jilin University

    Changchun, 130021

  • Jilin Cancer Hospital

    Changchun, 132013

  • Changzhou First People's Hospital

    Changzhou, 213003

  • Third Affiliated Hospital of Third Military Medical University

    Chongqing, 400042

  • Fuzhou General Hospital, PLA Nanjing Military Area Command

    Fuzhou, 110016

  • Sun Yet-sen University Cancer Center

    Guangzhou, 510060

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

    Hangzhou, 310016

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • The 1st Affiliated Hospital of Nanchang Unversity

    Nanchang, 330006

  • The 81st Hospital of P.L.A.

    Nanjing, 210002

  • Affiliated Hospital of Nantong University

    Nantong, 226001

  • Zhongshan Hospital Fudan University

    Shanghai, 200032

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120

  • General Hospital of Shenyang Military Command of PLA

    Shenyang, 110016

  • Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)

    Shijiazhuang, 050035

  • The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)

    Xi'an, 710032

  • The Affiliated Hospital of Xuzhou Medical College

    Xuzhou, 221000

  • Henan Cancer Hospital

    Zhengzhou, 450008

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052

Other trials in China

Japan15 sites

  • Aichi Cancer Center Hospital; Clinical Oncology

    Aichi, 464-8681

  • Nagoya university Hospital; Gastroenterological Surgery 2

    Aichi, 466-8560

  • National Cancer Center Hospital East; Gastroenterology

    Chiba, 277-8577

  • National Hospital Organization Shikoku Cancer Center; Gastroenterology

    Ehime, 791-0280

  • Kyushu University Hospital; Surgery and Science

    Fukuoka, 812-8582

  • Gifu University Hospital; Digestive Surgery

    Gifu, 501-1194

  • Hiroshima City Hiroshima Citizens Hospital; Surgery

    Hiroshima, 730-8518

  • Kobe city Medical center General Hospital; Medical Oncology

    Hyōgo, 650-0047

  • St.Marianna University School of Medicine hospital; Medical Oncology

    Kanagawa, 216-8511

  • Kanagawa Cancer Center; Gastrointestinal Surgery

    Kanagawa, 241-8515

  • Osaka International Cancer Institute;; Medical oncology and Gastrointestinal oncology

    Osaka, 541-8567

  • Osaka General Medical Center; Gastroenterological Surgery

    Osaka, 558-8558

  • Saitama Cancer Center; Gastroenterology

    Saitama, 362-0806

  • National Cancer Center Hospital; Gastrointestinal Oncology

    Tokyo, 104-0045

  • Toyama University Hospital;Gastroenterology and Hematology

    Toyama, 930-0194

Other trials in Japan

Italy12 sites

  • Ospedali Riuniti Di Ancona; Oncology

    Ancona, The Marches, 60121

  • Asst Papa Giovanni XXIII; Oncologia Medica

    Bergamo, Lombardy, 24127

  • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

    Bologna, Emilia-Romagna, 40138

  • Irccs Ospedale San Raffaele

    Milan, Lombardy, 20132

  • Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

    Milan, Lombardy, 20141

  • Seconda Universita' Degli Studi; Divsione Di Oncologia Medica

    Naples, Campania, 80131

  • Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2

    Pisa, Tuscany, 56100

  • Ospedale Misericordia E Dolce; Oncologia Medica

    Prato, Tuscany, 59100

  • AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia

    Reggio Emilia, Emilia-Romagna, 42100

  • Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 00168

  • Ospedale Casa Sollievo Della Sofferenza IRCCS

    San Giovanni Rotondo, Apulia, 71013

  • Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Germany11 sites

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

    Berlin, 10117

  • Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung

    Essen, 45122

  • Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Internistische Onkologie / Haematologie

    Essen, 45136

  • Klinik Esslingen; Klinik für Allgemeine Innere Medizin, Onkologie/Haematologie

    Esslingen am Neckar, 73730

  • Universitätsklinikum Hamburg-Eppendorf; Hubertus Wald Tumorzentrum

    Hamburg, 20246

  • Universitaetsklinikum Leipzig, Universitaeres Krebszentrum Leipzig (UCCL)

    Leipzig, 04103

  • Klinikum Ludwigsburg; Studiensekretariat

    Ludwigsburg, 71640

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz; II. Medizinische Klinik

    Mainz, 55131

  • Universitätsklinikum Mannheim, Tagestherapiezentrum, Interdisziplinäres Tumorzentrum

    Mannheim, 68167

  • Philipps-Universität Marburg; Klinik für Innere Med.; Schwerpunkt Hämatologie/Onkologie/Immunologie

    Marburg, 35043

  • Universitätsklinikum Ulm; Zentrum für Innere Medizin Klinik für Innere Medizin I

    Ulm, 89081

Other trials in Germany

United States10 sites

  • New York Oncology Hematology, P.C.

    Albany, New York, 12206

  • Medical University of South Carolina; Hollings Cancer Center

    Charleston, South Carolina, 29425

  • University Of Chicago Medical Center; Section Of Hematology/Oncology

    Chicago, Illinois, 60637

  • Oncology Hematology Care

    Cincinnati, Ohio, 45219

  • Florida Cancer Specialists - SCRI; Pharmacy

    Fort Myers, Florida, 33901

  • Queens Medical Associates

    Fresh Meadows, New York, 11366

  • Indiana University Health; Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • Comprehensive Cancer Centers of Nevada - Eastern Avenue

    Las Vegas, Nevada, 89169

  • Tennessee Oncology PLLC - Nashville (20th Ave)

    Nashville, Tennessee, 37203

  • Weill Medical College of Cornell University; Division of Hematology & Medical Oncology

    New York, New York, 10065

Other trials in United States

Spain9 sites

  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

    Badalona, Barcelona, 08916

  • Hospital del Mar; Servicio de Oncologia

    Barcelona, 08003

  • Hospital Univ Vall d'Hebron; Servicio de Oncologia

    Barcelona, 08035

  • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

    Barcelona, 08041

  • Hospital Duran i Reynals; Oncologia

    Barcelona, 08907

  • Hospital Universitario Reina Sofia; Servicio de Oncologia

    Córdoba, Cordoba, 14004

  • Hospital General Universitario de Elche; Servicio de Oncologia

    Elche, Alicante, 03203

  • Hospital Ramon y Cajal; Servicio de Oncologia

    Madrid, 28034

  • Hospital Universitario 12 de Octubre; Servicio de Oncologia

    Madrid, 28041

Other trials in Spain

Brazil8 sites

  • Centro de Pesquisas Oncologicas - CEPON

    Florianópolis, Santa Catarina, 88034-000

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul

  • Clinicas Oncologicas Integradas - COI

    Rio de Janeiro, Rio de Janeiro, 22290-160

  • Hospital Sirio Libanes; Centro de Oncologia

    São Paulo, São Paulo, 01308-050

  • Clinica de Oncologia Medica

    São Paulo, São Paulo, 01406100

  • Hospital A. C. Camargo; Oncologia

    São Paulo, São Paulo, 01509-010

  • Universidade Federal de Sao Paulo - UNIFESP*X

    São Paulo, São Paulo, 22793-080

Other trials in Brazil

Poland8 sites

  • Bialostockie Ctr Onkologii; Oddzial Chemioterapii Dziennej

    Bialystok, 15-027

  • Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny

    Brzozów, 36-200

  • Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii

    Bydgoszcz, 85-796

  • Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

    Krakow, 30-688

  • SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego

    Opole, 45-060

  • NZOZ Centrum Medyczne HCP Sp. z o.o.

    Poznan, 61-485

  • Wojewódzki Szpital Specjalistyczny Nr 3

    Rybnik, 44-200

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

    Warsaw, 02-781

Other trials in Poland

Canada7 sites

  • Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1

  • Hamilton Health Sciences - Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • McGill University; Glen Site; Oncology

    Montreal, Quebec, H4A 3J1

  • Toronto East General Hospital; Haematology/Oncology

    Toronto, Ontario, M4C 3E7

  • Sunnybrook Health Science Centre

    Toronto, Ontario, M4N 3M5

  • Mount Sinai Hospital; Oncology

    Toronto, Ontario, M5G 1X5

Other trials in Canada

Turkey (Türkiye)7 sites

  • Ankara Uni School of Medicine; Medical Oncology

    Ankara, 06590

  • Akdeniz University Medical Faculty; Medical Oncology Department

    Antalya, 07070

  • Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

    Edirne, 22770

  • Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department

    Erzurum, 25240

  • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

    Istanbul, 34300

  • TC Necmettin Erbakan University Meram Medical Faculty Hospital

    Konya, 42080

  • Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

    Malatya, 44280

Other trials in Turkey (Türkiye)

South Korea6 sites

  • Kyungpook National University Medical Center

    Daegu, 41404

  • Samsung Medical Center

    Seoul, (0)6351

  • Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

    Seoul, 03080

  • Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology

    Seoul, 03722

  • Asan Medical Center; Medical Oncology

    Seoul, 05505

  • Seoul St Mary's Hospital

    Seoul, 06591

Other trials in South Korea

Hungary5 sites

  • Semmelweis Egyetem Onkologiai Központ

    Budapest, 1083

  • Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

    Budapest, 1122

  • Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika

    Debrecen, 4032

  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz;Sugarterapias Klinikai Onkologiai Intez

    Miskolc, 3526

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

    Szeged, 6720

Other trials in Hungary

Peru5 sites

  • Centro Medico Monte Carmelo

    Arequipa, 04001

  • Hospital Sabogal; Oncology

    Callao, 02

  • Hosp Nacion Edgardo Rebagliati; Oncologia Medica

    Jesus Maria, Lima 11

  • Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

    Lima, Lima 41

  • Clinica San Borja

    Lima, Lima 41

Other trials in Peru

Taiwan5 sites

  • Taichung Veterans General Hospital; Dept of Surgery

    Taichung, 407

  • National Cheng Kung University Hospital; Oncology

    Tainan, 00704

  • National Taiwan Uni Hospital; Dept of Oncology

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 112

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

    Taoyuan, 333

Other trials in Taiwan

Thailand5 sites

  • Rajavithi Hospital; Division of Medical Oncology

    Bangkok, 10400

  • Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

    Bangkok, 10400

  • Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

    Bangkok, 10700

  • Khonkaen Hospital

    Khonkaen, 40000

  • Songklanagarind Hospital; Department of Oncology

    Songkhla, 90110

Other trials in Thailand

Australia4 sites

  • Monash Medical Centre; Oncology

    Clayton, Victoria, 3168

  • Austin Health; Cancer Clinical Trial Centre

    Heidelberg, Victoria, 3084

  • Royal Brisbane Womens Hosp; Division of Oncology

    Herston, Queensland, 4029

  • Sir Charles Gairdner Hospital; Medical Oncology

    Perth, Western Australia, 6009

Other trials in Australia

Malaysia4 sites

  • Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi

    Kuala Lumpur, 50586

  • University Malaya Medical Centre; Clinical Oncology Unit,

    Kuala Lumpur, 59100

  • Hospital Universiti Sains Malaysia [Neurology]

    Kubang Kerian, Kelantan, 16150

  • Hospital Wanita dan Kanak-Kanak Sabah

    Sabah, Sabah, 88996

Other trials in Malaysia

Russia4 sites

  • Clinical Oncology Dispensary of Ministry of Health of Tatarstan

    Kazan', 420029

  • Clinical Oncology Dispensary; Chemotherapy

    Omsk, 644013

  • SBI for HPE "Ryazan State Medical University n.a. I.P. Pavlov" of MoH of RF

    Ryazan, 390011

  • SBI of Healthcare Samara Regional Clinical Oncology Dispensary

    Samara, 443031

Other trials in Russia

Bulgaria3 sites

  • Complex Oncological Center - Plovdiv, EOOD

    Plovdiv, 4004

  • MHAT Serdika

    Sofia, 1301

  • SHATOD Dr. Marko Antonov Markov-Varna, EOOD; Department of Medicinall Onchotherapy and Palliative

    Varna, 9010

Other trials in Bulgaria

Mexico3 sites

  • Hospital Angeles Metropolitano; Room 220

    Mexico City, Mexico CITY (federal District), 06760

  • Inst. Nacional de Cancerologia; Investigacion Clinica

    Mexico City, 14000

  • Oaxaca Site Management Organization

    Oaxaca City, 68000

Other trials in Mexico

Romania3 sites

  • Cardiomed Medical Center

    Cluj-Napoca, 400015

  • Oncology Center Sf. Nectarie

    Craiova, 200347

  • Euroclinic Center of Oncology SRL

    Iași, 700106

Other trials in Romania

Austria2 sites

  • Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

    Salzburg, 5020

  • Krankenhaus St. Vinzenz Der Barmherzigen Schwestern Zams; Abt. Für Innere Medizin

    Zams, 6511

Other trials in Austria

Croatia2 sites

  • Clinical Hospital Centre Zagreb

    Zagreb, 10000

  • Clinical Hospital Sisters of Mercy

    Zagreb, 10000

Other trials in Croatia

Finland2 sites

  • Docrates Cance Center

    Helsinki, 00180

  • Turku Uni Central Hospital; Oncology Clinics

    Turku, 20520

Other trials in Finland

North Macedonia2 sites

  • Clinical Hospital; Oncology Department

    Bitola, 7000

  • University Clinic for Radiotherapy and Oncology

    Skopje, 1000

Other trials in North Macedonia

Switzerland2 sites

  • CHUV; Departement d'Oncologie

    Lausanne, 1011

  • Luzerner Kantonsspital; Medizinische Onkologie

    Lucerne, 6004

Other trials in Switzerland

Belgium1 site

  • Cliniques Universitaires St-Luc

    Brussels, 1200

Other trials in Belgium

El Salvador1 site

  • Hospital Oncologia; Oncology

    San Salvador, 01101

Other trials in El Salvador

Guatemala1 site

  • Medical Solution; Hematology

    Guatemala City, 01-010

Other trials in Guatemala

Kazakhstan1 site

  • Kazakh Scientific Research Institution Of Oncology and Radiology; Chemotherapy department

    Almaty, 050022

Other trials in Kazakhstan

Netherlands1 site

  • Academisch Medisch Centrum Universiteit Amsterdam

    Amsterdam, 1105 AZ

Other trials in Netherlands

Panama1 site

  • Medical Research Centre

    Panama City

Other trials in Panama

About this study

Official title: A Double-Blind, Placebo-Controlled, Randomized, Multicenter Phase III Study Evaluating the Efficacy and Safety of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Metastatic Gastroesophageal Junction and Gastric Cancer

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.

Conditions
Gastric Cancer
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • 5-FluorouracilDrug

    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.

  • CapecitabineDrug

    Also called Xeloda

    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.

  • CisplatinDrug

    Participants will receive cisplatin 80 mg/m^2 IV q3w for 6 cycles.

  • PertuzumabDrug

    Also called Perjeta, RO4368451

    Participants will receive pertuzumab 840 mg IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.

  • PlaceboDrug

    Participants will receive placebo (matched to pertuzumab) IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.

  • TrastuzumabDrug

    Also called Herceptin, RO0452317

    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.

Study groups in NCT01774786
Study groupRoleWhat they receive
Pertuzumab + Trastuzumab + ChemotherapyExperimentalParticipants 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). Thereafter, participants will continue to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Receives: Drug: 5-Fluorouracil; Drug: Capecitabine; Drug: Cisplatin; Drug: Pertuzumab; Drug: Trastuzumab
Placebo + Trastuzumab + ChemotherapyPlacebo comparatorParticipants will receive placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants will continue to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Receives: Drug: 5-Fluorouracil; Drug: Capecitabine; Drug: Cisplatin; Drug: Placebo; Drug: Trastuzumab

What is being measured

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

  1. Overall Survival

    Overall survival (OS) was defined as the time from randomization to death from any cause. For participants who were still alive on the date of clinical data cut-off for the OS analysis, the last date when the participant was known to be alive on, or prior to the clinical cut-off date, was used to determine the censoring date. Participants who did not have any post-baseline data (e.g., dosing records, imaging dates, visit dates) were censored at the date of randomization plus 1 day.

    Measured: From Baseline until death from any cause (Median [full range] duration of follow-up in Pertuzumab vs. Placebo arms for Primary Analysis: 24.4 [0-42] months vs. 25.0 [0-41] months; Final Analysis: 46.1 [0-70] months vs. 44.4 [0-68] months)

Secondary outcomes (13)

  1. Progression-Free Survival, as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Criteria

    Progression-free survival (PFS) is defined as the time from randomization to the first occurrence of progressive disease (PD), as determined by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Tumor assessments with CT or MRI scans of the chest, abdomen, and pelvis were performed every 9 weeks. Participants without documented PD or death were censored at the tumor assessment date for which the participant was last known to be progression-free. Participants who did not have any post-baseline tumor assessment data were censored at the date of randomization plus 1 day. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 millimeters (mm) in the sum of diameters of target lesions; the appearance of one or more new lesions.

    Measured: Baseline to death or progressive disease (PD), whichever occurred first (Median [full range] duration of follow-up in Pertuzumab vs. Placebo arms for Primary Analysis: 24.9 [0-41] vs. 21.3 [0-39] months; Final Analysis: 50.4 [0-70] vs. 47.4 [0-66] months)

  2. Primary Analysis of the Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria

    The overall objective response rate was defined as the percentage of participants with partial response (PR) or complete response (CR) occurring on two consecutive occasions ≥4 weeks apart, as determined by the investigator using RECIST v1.1. Tumor assessments with computed tomography (CT) or magnetic resonance imaging (MRI) scans of the chest, abdomen, and pelvis were performed every 9 weeks. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR: disappearance of all target lesions. Measurable disease is defined as tumor lesions measured in at least one dimension (longest diameter in plane of measurement) with a minimum size of: 10 mm by CT or MRI scan; 10 mm caliper measurement by clinical examination; 20 mm by chest X-ray. For a malignant lymph node to be considered pathologically enlarged and measurable, it must be greater than or equal to (≥) 15 mm in short axis when assessed by CT scan.

    Measured: Baseline up to death or progressive disease, whichever occurred first (Median [full range] duration of follow-up in Pertuzumab vs. Placebo arms for Primary Analysis: 24.9 [0-41] months vs. 21.3 [0-39] months)

  3. Final Analysis of the Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria

    The overall objective response rate was defined as the percentage of participants with partial response (PR) or complete response (CR) occurring on two consecutive occasions ≥4 weeks apart, as determined by the investigator using RECIST v1.1. Tumor assessments with computed tomography (CT) or magnetic resonance imaging (MRI) scans of the chest, abdomen, and pelvis were performed every 9 weeks. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR: disappearance of all target lesions. Measurable disease is defined as tumor lesions measured in at least one dimension (longest diameter in plane of measurement) with a minimum size of: 10 mm by CT or MRI scan; 10 mm caliper measurement by clinical examination; 20 mm by chest X-ray. For a malignant lymph node to be considered pathologically enlarged and measurable, it must be greater than or equal to (≥) 15 mm in short axis when assessed by CT scan.

    Measured: Baseline up to death or progressive disease, whichever occurred first (Median [full range] duration of follow-up in Pertuzumab vs. Placebo arms for Final Analysis: 50.4 [0-70] months vs. 47.4 [0-66] months)

  4. Duration of Objective Response, as Determined by Investigator According to RECIST v1.1 Criteria

    Duration of objective response is defined as the time from first occurrence of documented objective response to documented disease progression, as determined by the investigator using RECIST v1.1, or death from any cause. Objective response: PR or CR occurring on 2 consecutive occasions ≥4 weeks apart. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR: disappearance of all target lesions. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions. Measurable disease defined as tumor lesions with a minimum size of: 10 mm by CT or MRI scan; 10 mm caliper measurement by clinical examination; 20 mm by chest X-ray. For a malignant lymph node, it must be ≥15 mm in short axis when assessed by CT scan.

    Measured: Baseline to death or progressive disease (PD), whichever occurred first (Median [full range] duration of follow-up in Pertuzumab vs. Placebo arms for Primary Analysis: 24.9 [0-41] vs. 21.3 [0-39] months; Final Analysis: 50.4 [0-70] vs. 47.4 [0-66] months)

  5. Percentage of Participants With Clinical Benefit, as Determined by the Investigator According to RECIST v1.1 Criteria

    The clinical benefit rate was defined as best response of complete response (CR) or partial response (PR) or stable disease (SD) for 6 weeks or longer, as determined by the investigator using RECIST v1.1. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum diameters while on study. Measurable disease is defined as tumor lesions measured in at least one dimension (longest diameter in plane of measurement) with a minimum size of: 10 mm by CT or MRI scan; 10 mm caliper measurement by clinical examination; 20 mm by chest X-ray. For a malignant lymph node to be considered pathologically enlarged and measurable, it must be >/=15 mm in short axis when assessed by CT scan. The clinical benefit rate was not updated at the final analysis.

    Measured: Baseline up to death or progressive disease, whichever occurred first (Median [full range] duration of follow-up in Pertuzumab vs. Placebo arms for Primary Analysis: 24.9 [0-41] months vs. 21.3 [0-39] months)

  6. Overview of Safety: Number of Participants With at Least One Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03

    An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. The investigator graded all AEs for severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.

    Measured: From Baseline until end of post-treatment follow-up (up to 70 months)

  7. Number of Participants With Symptomatic or Asymptomatic Left Ventricular Systolic Dysfunction (LVSD)

    The number and percentage of participants with symptomatic left ventricular systolic dysfunction (LVSD) and asymptomatic LVSD events (defined as a left ventricular ejection fraction [LVEF] ≥10% decrease from baseline to an absolute value <50%) at any time during the study was summarized by treatment arm.

    Measured: From Baseline until end of post-treatment follow-up (up to 70 months)

  8. Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score

    The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be a minimally important difference to participants. A positive value means an increase, while a negative value means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1).

    Measured: Day 1 of each 21-day treatment cycle up to 28 and 60-90 days (post-treatment [PT] monitoring visits 1 and 2, respectively) after Day 1 of last treatment cycle (up to approximately 3.5 years)

  9. Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score

    The EORTC QLQ-STO22 is a gastric cancer quality of life questionnaire. There are 22 questions concerning disease, treatment related symptoms, side effects, dysphagia, nutritional aspects, and questions about the emotional problems of gastric cancer (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, body image, and hair loss). The questions are grouped into five scales and 4 single items which are related to the symptoms of the disease. Most questions used 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. A positive value means an increase, while a negative values means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1).

    Measured: Day 1 of each 21-day treatment cycle up to 28 and 60-90 days (post-treatment [PT] monitoring visits 1 and 2, respectively) after Day 1 of last treatment cycle (up to approximately 3.5 years)

  10. Maximum Serum Concentration (Cmax) of Pertuzumab

    Measured: Post-dose (0.5 hour after end of 30-60 minutes infusion) on Day 1 of Cycles 1, 2, 4, and 8 (1 cycle = 21 days)

  11. Cmax of Trastuzumab

    Measured: Post-dose (0.5 hour after end of 30-60 minutes infusion) on Day 1 of Cycles 1, 2, 4, and 8 (1 cycle = 21 days)

  12. Minimum Serum Concentration (Cmin) of Pertuzumab

    Measured: Pre-dose (0-6 hours before infusion) on Day 1 of Cycles 1, 2, 3, 4, 6, and 8 (1 cycle = 21 days)

  13. Cmin of Trastuzumab

    Measured: Pre-dose (0-6 hours before infusion) on Day 1 of Cycles 1, 2, 3, 4, 6, and 8 (1 cycle = 21 days)

Timeline

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

  1. First posted24 Jan 2013 (estimated)
  2. Study start10 Jun 2013
  3. Primary completion9 Dec 2016
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
780 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01774786
Sponsor's protocol ID
BO25114
Other IDs
2012-003554-83
Acronym
JACOB
Status last verified
Dec 2020
First submitted
21 Jan 2013
Last updated
30 Dec 2020
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Tabernero J, Hoff PM, Shen L, Ohtsu A, Shah MA, Siddiqui A, Heeson S, Kiermaier A, Macharia H, Restuccia E, Kang YK. Pertuzumab, trastuzumab, and chemotherapy in HER2-positive gastric/gastroesophageal junction cancer: end-of-study analysis of the JACOB phase III randomized clinical trial. Gastric Cancer. 2023 Jan;26(1):123-131. doi: 10.1007/s10120-022-01335-4. Epub 2022 Sep 6.

    PubMed 36066725

  • Liu T, Qin Y, Li J, Xu R, Xu J, Yang S, Qin S, Bai Y, Wu C, Mao Y, Wu H, Ge Y, Shen L. Pertuzumab in combination with trastuzumab and chemotherapy for Chinese patients with HER2-positive metastatic gastric or gastroesophageal junction cancer: a subpopulation analysis of the JACOB trial. Cancer Commun (Lond). 2019 Jun 24;39(1):38. doi: 10.1186/s40880-019-0384-6.

    PubMed 31234927

  • Kirschbrown WP, Wang B, Nijem I, Ohtsu A, Hoff PM, Shah MA, Shen L, Kang YK, Alsina M, Girish S, Garg A. Pharmacokinetic and exposure-response analysis of pertuzumab in patients with HER2-positive metastatic gastric or gastroesophageal junction cancer. Cancer Chemother Pharmacol. 2019 Sep;84(3):539-550. doi: 10.1007/s00280-019-03871-w. Epub 2019 Jun 10.

    PubMed 31183514

  • Tabernero J, Hoff PM, Shen L, Ohtsu A, Shah MA, Cheng K, Song C, Wu H, Eng-Wong J, Kim K, Kang YK. Pertuzumab plus trastuzumab and chemotherapy for HER2-positive metastatic gastric or gastro-oesophageal junction cancer (JACOB): final analysis of a double-blind, randomised, placebo-controlled phase 3 study. Lancet Oncol. 2018 Oct;19(10):1372-1384. doi: 10.1016/S1470-2045(18)30481-9. Epub 2018 Sep 11.

    PubMed 30217672

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 5-Fluorouracil, Capecitabine and Cisplatin in people with Gastric Cancer, run by Hoffmann-La Roche at 172 sites in 32 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 172 sites in China, Japan, Italy, Germany, United States and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: From Baseline until death from any cause (Median [full range] duration of follow-up in Pertuzumab vs. Placebo arms for Primary Analysis: 24.4 [0-42] months vs. 25.0 [0-41] months; Final Analysis: 46.1 [0-70] months vs. 44.4 [0-68] months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01774786, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2020.

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