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

NCT ID: NCT01774786

Last Updated: 2020-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

780 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-10

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Pertuzumab + Trastuzumab + Chemotherapy

Participants 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.

Group Type EXPERIMENTAL

5-Fluorouracil

Intervention Type DRUG

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.

Capecitabine

Intervention Type DRUG

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.

Cisplatin

Intervention Type DRUG

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

Pertuzumab

Intervention Type DRUG

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

Trastuzumab

Intervention Type DRUG

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.

Placebo + Trastuzumab + Chemotherapy

Participants 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.

Group Type PLACEBO_COMPARATOR

5-Fluorouracil

Intervention Type DRUG

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.

Capecitabine

Intervention Type DRUG

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.

Cisplatin

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Trastuzumab

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Cisplatin

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

Intervention Type 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.

Intervention Type DRUG

Placebo

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Xeloda Perjeta RO4368451 Herceptin RO0452317

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Florida Cancer Specialists - SCRI; Pharmacy

Fort Myers, Florida, United States

Site Status

University Of Chicago Medical Center; Section Of Hematology/Oncology

Chicago, Illinois, United States

Site Status

Indiana University Health; Goshen Center for Cancer Care

Goshen, Indiana, United States

Site Status

Comprehensive Cancer Centers of Nevada - Eastern Avenue

Las Vegas, Nevada, United States

Site Status

New York Oncology Hematology, P.C.

Albany, New York, United States

Site Status

Queens Medical Associates

Fresh Meadows, New York, United States

Site Status

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

New York, New York, United States

Site Status

Oncology Hematology Care

Cincinnati, Ohio, United States

Site Status

Medical University of South Carolina; Hollings Cancer Center

Charleston, South Carolina, United States

Site Status

Tennessee Oncology PLLC - Nashville (20th Ave)

Nashville, Tennessee, United States

Site Status

Royal Brisbane Womens Hosp; Division of Oncology

Herston, Queensland, Australia

Site Status

Monash Medical Centre; Oncology

Clayton, Victoria, Australia

Site Status

Austin Health; Cancer Clinical Trial Centre

Heidelberg, Victoria, Australia

Site Status

Sir Charles Gairdner Hospital; Medical Oncology

Perth, Western Australia, Australia

Site Status

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

Salzburg, , Austria

Site Status

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

Zams, , Austria

Site Status

Cliniques Universitaires St-Luc

Brussels, , Belgium

Site Status

Clinicas Oncologicas Integradas - COI

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Centro de Pesquisas Oncologicas - CEPON

Florianópolis, Santa Catarina, Brazil

Site Status

Hospital Sirio Libanes; Centro de Oncologia

São Paulo, São Paulo, Brazil

Site Status

Clinica de Oncologia Medica

São Paulo, São Paulo, Brazil

Site Status

Hospital A. C. Camargo; Oncologia

São Paulo, São Paulo, Brazil

Site Status

Universidade Federal de Sao Paulo - UNIFESP*X

São Paulo, São Paulo, Brazil

Site Status

Complex Oncological Center - Plovdiv, EOOD

Plovdiv, , Bulgaria

Site Status

MHAT Serdika

Sofia, , Bulgaria

Site Status

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

Varna, , Bulgaria

Site Status

Health Sciences North

Greater Sudbury, Ontario, Canada

Site Status

Hamilton Health Sciences - Juravinski Cancer Centre

Hamilton, Ontario, Canada

Site Status

London Regional Cancer Centre

London, Ontario, Canada

Site Status

Toronto East General Hospital; Haematology/Oncology

Toronto, Ontario, Canada

Site Status

Sunnybrook Health Science Centre

Toronto, Ontario, Canada

Site Status

Mount Sinai Hospital; Oncology

Toronto, Ontario, Canada

Site Status

McGill University; Glen Site; Oncology

Montreal, Quebec, Canada

Site Status

Cancer Hospital Chinese Academy of Medical Sciences.

Beijing, , China

Site Status

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

Beijing, , China

Site Status

Beijing Cancer Hospital

Beijing, , China

Site Status

the First Hospital of Jilin University

Changchun, , China

Site Status

Jilin Cancer Hospital

Changchun, , China

Site Status

Changzhou First People's Hospital

Changzhou, , China

Site Status

Third Affiliated Hospital of Third Military Medical University

Chongqing, , China

Site Status

Fuzhou General Hospital, PLA Nanjing Military Area Command

Fuzhou, , China

Site Status

Sun Yet-sen University Cancer Center

Guangzhou, , China

Site Status

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

Hangzhou, , China

Site Status

Harbin Medical University Cancer Hospital

Harbin, , China

Site Status

The 1st Affiliated Hospital of Nanchang Unversity

Nanchang, , China

Site Status

The 81st Hospital of P.L.A.

Nanjing, , China

Site Status

Affiliated Hospital of Nantong University

Nantong, , China

Site Status

Zhongshan Hospital Fudan University

Shanghai, , China

Site Status

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status

General Hospital of Shenyang Military Command of PLA

Shenyang, , China

Site Status

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

Shijiazhuang, , China

Site Status

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

Xi'an, , China

Site Status

The Affiliated Hospital of Xuzhou Medical College

Xuzhou, , China

Site Status

Henan Cancer Hospital

Zhengzhou, , China

Site Status

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, , China

Site Status

Clinical Hospital Centre Zagreb

Zagreb, , Croatia

Site Status

Clinical Hospital Sisters of Mercy

Zagreb, , Croatia

Site Status

Hospital Oncologia; Oncology

San Salvador, , El Salvador

Site Status

Docrates Cance Center

Helsinki, , Finland

Site Status

Turku Uni Central Hospital; Oncology Clinics

Turku, , Finland

Site Status

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

Berlin, , Germany

Site Status

Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung

Essen, , Germany

Site Status

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

Essen, , Germany

Site Status

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

Esslingen am Neckar, , Germany

Site Status

Universitätsklinikum Hamburg-Eppendorf; Hubertus Wald Tumorzentrum

Hamburg, , Germany

Site Status

Universitaetsklinikum Leipzig, Universitaeres Krebszentrum Leipzig (UCCL)

Leipzig, , Germany

Site Status

Klinikum Ludwigsburg; Studiensekretariat

Ludwigsburg, , Germany

Site Status

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

Mainz, , Germany

Site Status

Universitätsklinikum Mannheim, Tagestherapiezentrum, Interdisziplinäres Tumorzentrum

Mannheim, , Germany

Site Status

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

Marburg, , Germany

Site Status

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

Ulm, , Germany

Site Status

Medical Solution; Hematology

Guatemala City, , Guatemala

Site Status

Semmelweis Egyetem Onkologiai Központ

Budapest, , Hungary

Site Status

Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

Budapest, , Hungary

Site Status

Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika

Debrecen, , Hungary

Site Status

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

Miskolc, , Hungary

Site Status

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

Szeged, , Hungary

Site Status

Ospedale Casa Sollievo Della Sofferenza IRCCS

San Giovanni Rotondo, Apulia, Italy

Site Status

Seconda Universita' Degli Studi; Divsione Di Oncologia Medica

Napoli, Campania, Italy

Site Status

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

Bologna, Emilia-Romagna, Italy

Site Status

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

Reggio Emilia, Emilia-Romagna, Italy

Site Status

Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia

Udine, Friuli Venezia Giulia, Italy

Site Status

Policlinico Universitario Agostino Gemelli

Rome, Lazio, Italy

Site Status

Asst Papa Giovanni XXIII; Oncologia Medica

Bergamo, Lombardy, Italy

Site Status

Irccs Ospedale San Raffaele

Milan, Lombardy, Italy

Site Status

Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

Milan, Lombardy, Italy

Site Status

Ospedali Riuniti Di Ancona; Oncology

Ancona, The Marches, Italy

Site Status

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

Pisa, Tuscany, Italy

Site Status

Ospedale Misericordia E Dolce; Oncologia Medica

Prato, Tuscany, Italy

Site Status

Aichi Cancer Center Hospital; Clinical Oncology

Aichi, , Japan

Site Status

Nagoya university Hospital; Gastroenterological Surgery 2

Aichi, , Japan

Site Status

National Cancer Center Hospital East; Gastroenterology

Chiba, , Japan

Site Status

National Hospital Organization Shikoku Cancer Center; Gastroenterology

Ehime, , Japan

Site Status

Kyushu University Hospital; Surgery and Science

Fukuoka, , Japan

Site Status

Gifu University Hospital; Digestive Surgery

Gifu, , Japan

Site Status

Hiroshima City Hiroshima Citizens Hospital; Surgery

Hiroshima, , Japan

Site Status

Kobe city Medical center General Hospital; Medical Oncology

Hyōgo, , Japan

Site Status

St.Marianna University School of Medicine hospital; Medical Oncology

Kanagawa, , Japan

Site Status

Kanagawa Cancer Center; Gastrointestinal Surgery

Kanagawa, , Japan

Site Status

Osaka International Cancer Institute;; Medical oncology and Gastrointestinal oncology

Osaka, , Japan

Site Status

Osaka General Medical Center; Gastroenterological Surgery

Osaka, , Japan

Site Status

Saitama Cancer Center; Gastroenterology

Saitama, , Japan

Site Status

National Cancer Center Hospital; Gastrointestinal Oncology

Tokyo, , Japan

Site Status

Toyama University Hospital;Gastroenterology and Hematology

Toyama, , Japan

Site Status

Kazakh Scientific Research Institution Of Oncology and Radiology; Chemotherapy department

Almaty, , Kazakhstan

Site Status

Hospital Universiti Sains Malaysia [Neurology]

Kubang Kerian, Kelantan, Malaysia

Site Status

Hospital Wanita dan Kanak-Kanak Sabah

Sabah, Sabah, Malaysia

Site Status

Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi

Kuala Lumpur, , Malaysia

Site Status

University Malaya Medical Centre; Clinical Oncology Unit,

Kuala Lumpur, , Malaysia

Site Status

Hospital Angeles Metropolitano; Room 220

Mexico City, Mexico CITY (federal District), Mexico

Site Status

Inst. Nacional de Cancerologia; Investigacion Clinica

Mexico City, , Mexico

Site Status

Oaxaca Site Management Organization

Oaxaca City, , Mexico

Site Status

Academisch Medisch Centrum Universiteit Amsterdam

Amsterdam, , Netherlands

Site Status

Clinical Hospital; Oncology Department

Bitola, , North Macedonia

Site Status

University Clinic for Radiotherapy and Oncology

Skopje, , North Macedonia

Site Status

Medical Research Centre

Panama City, , Panama

Site Status

Centro Medico Monte Carmelo

Arequipa, , Peru

Site Status

Hospital Sabogal; Oncology

Callao, , Peru

Site Status

Hosp Nacion Edgardo Rebagliati; Oncologia Medica

Jesus Maria, , Peru

Site Status

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

Lima, , Peru

Site Status

Clinica San Borja

Lima, , Peru

Site Status

Bialostockie Ctr Onkologii; Oddzial Chemioterapii Dziennej

Bialystok, , Poland

Site Status

Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny

Brzozów, , Poland

Site Status

Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii

Bydgoszcz, , Poland

Site Status

Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

Krakow, , Poland

Site Status

SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego

Opole, , Poland

Site Status

NZOZ Centrum Medyczne HCP Sp. z o.o.

Poznan, , Poland

Site Status

Wojewódzki Szpital Specjalistyczny Nr 3

Rybnik, , Poland

Site Status

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

Warsaw, , Poland

Site Status

Cardiomed Medical Center

Cluj-Napoca, , Romania

Site Status

Oncology Center Sf. Nectarie

Craiova, , Romania

Site Status

Euroclinic Center of Oncology SRL

Iași, , Romania

Site Status

Clinical Oncology Dispensary of Ministry of Health of Tatarstan

Kazan', , Russia

Site Status

Clinical Oncology Dispensary; Chemotherapy

Omsk, , Russia

Site Status

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

Ryazan, , Russia

Site Status

SBI of Healthcare Samara Regional Clinical Oncology Dispensary

Samara, , Russia

Site Status

Kyungpook National University Medical Center

Daegu, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

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

Seoul, , South Korea

Site Status

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

Seoul, , South Korea

Site Status

Asan Medical Center; Medical Oncology

Seoul, , South Korea

Site Status

Seoul St Mary's Hospital

Seoul, , South Korea

Site Status

Hospital General Universitario de Elche; Servicio de Oncologia

Elche, Alicante, Spain

Site Status

Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

Badalona, Barcelona, Spain

Site Status

Hospital Universitario Reina Sofia; Servicio de Oncologia

Córdoba, Cordoba, Spain

Site Status

Hospital del Mar; Servicio de Oncologia

Barcelona, , Spain

Site Status

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Barcelona, , Spain

Site Status

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

Barcelona, , Spain

Site Status

Hospital Duran i Reynals; Oncologia

Barcelona, , Spain

Site Status

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, , Spain

Site Status

Hospital Universitario 12 de Octubre; Servicio de Oncologia

Madrid, , Spain

Site Status

CHUV; Departement d'Oncologie

Lausanne, , Switzerland

Site Status

Luzerner Kantonsspital; Medizinische Onkologie

Lucerne, , Switzerland

Site Status

Taichung Veterans General Hospital; Dept of Surgery

Taichung, , Taiwan

Site Status

National Cheng Kung University Hospital; Oncology

Tainan City, , Taiwan

Site Status

National Taiwan Uni Hospital; Dept of Oncology

Taipei, , Taiwan

Site Status

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

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

Taoyuan District, , Taiwan

Site Status

Rajavithi Hospital; Division of Medical Oncology

Bangkok, , Thailand

Site Status

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

Bangkok, , Thailand

Site Status

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

Bangkok, , Thailand

Site Status

Khonkaen Hospital

Khonkaen, , Thailand

Site Status

Songklanagarind Hospital; Department of Oncology

Songkhla, , Thailand

Site Status

Ankara Uni School of Medicine; Medical Oncology

Ankara, , Turkey (Türkiye)

Site Status

Akdeniz University Medical Faculty; Medical Oncology Department

Antalya, , Turkey (Türkiye)

Site Status

Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

Edirne, , Turkey (Türkiye)

Site Status

Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department

Erzurum, , Turkey (Türkiye)

Site Status

Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

Istanbul, , Turkey (Türkiye)

Site Status

TC Necmettin Erbakan University Meram Medical Faculty Hospital

Konya, , Turkey (Türkiye)

Site Status

Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

Malatya, , Turkey (Türkiye)

Site Status

Countries

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United States Australia Austria Belgium Brazil Bulgaria Canada China Croatia El Salvador Finland Germany Guatemala Hungary Italy Japan Kazakhstan Malaysia Mexico Netherlands North Macedonia Panama Peru Poland Romania Russia South Korea Spain Switzerland Taiwan Thailand Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 36066725 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31234927 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31183514 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30217672 (View on PubMed)

Other Identifiers

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2012-003554-83

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BO25114

Identifier Type: -

Identifier Source: org_study_id