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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003554-83 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Experimental | 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. |
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| Placebo + Trastuzumab + Chemotherapy | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-Fluorouracil | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Cancer Specialists - SCRI; Pharmacy | Fort Myers | Florida | 33901 | United States | ||
| University Of Chicago Medical Center; Section Of Hematology/Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36066725 | Derived | 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. | |
| 31234927 |
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A total of 780 participants were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pertuzumab + Trastuzumab + Chemotherapy | Participants received 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 continued to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Capecitabine | 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. |
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| Cisplatin | Drug | Participants will receive cisplatin 80 mg/m^2 IV q3w for 6 cycles. |
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| Pertuzumab | Drug | Participants will receive pertuzumab 840 mg IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason. |
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| Placebo | 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. |
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| Trastuzumab | 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. |
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| 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | From Baseline until end of post-treatment follow-up (up to 70 months) |
| 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. | From Baseline until end of post-treatment follow-up (up to 70 months) |
| 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). | 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) |
| 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). | 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) |
| Maximum Serum Concentration (Cmax) of Pertuzumab | 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) |
| Cmax of Trastuzumab | 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) |
| Minimum Serum Concentration (Cmin) of Pertuzumab | Pre-dose (0-6 hours before infusion) on Day 1 of Cycles 1, 2, 3, 4, 6, and 8 (1 cycle = 21 days) |
| Cmin of Trastuzumab | Pre-dose (0-6 hours before infusion) on Day 1 of Cycles 1, 2, 3, 4, 6, and 8 (1 cycle = 21 days) |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Indiana University Health; Goshen Center for Cancer Care | Goshen | Indiana | 46526 | United States |
| Comprehensive Cancer Centers of Nevada - Eastern Avenue | Las Vegas | Nevada | 89169 | United States |
| New York Oncology Hematology, P.C. | Albany | New York | 12206 | United States |
| Queens Medical Associates | Fresh Meadows | New York | 11366 | United States |
| Weill Medical College of Cornell University; Division of Hematology & Medical Oncology | New York | New York | 10065 | United States |
| Oncology Hematology Care | Cincinnati | Ohio | 45219 | United States |
| Medical University of South Carolina; Hollings Cancer Center | Charleston | South Carolina | 29425 | United States |
| Tennessee Oncology PLLC - Nashville (20th Ave) | Nashville | Tennessee | 37203 | United States |
| Royal Brisbane Womens Hosp; Division of Oncology | Herston | Queensland | 4029 | Australia |
| Monash Medical Centre; Oncology | Clayton | Victoria | 3168 | Australia |
| Austin Health; Cancer Clinical Trial Centre | Heidelberg | Victoria | 3084 | Australia |
| Sir Charles Gairdner Hospital; Medical Oncology | Perth | Western Australia | 6009 | Australia |
| Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt. | Salzburg | 5020 | Austria |
| Krankenhaus St. Vinzenz Der Barmherzigen Schwestern Zams; Abt. Für Innere Medizin | Zams | 6511 | Austria |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| Clinicas Oncologicas Integradas - COI | Rio de Janeiro | Rio de Janeiro | 22290-160 | Brazil |
| Hospital Nossa Senhora da Conceicao | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
| Hospital das Clinicas - UFRGS | Porto Alegre | Rio Grande do Sul | Brazil |
| Centro de Pesquisas Oncologicas - CEPON | Florianópolis | Santa Catarina | 88034-000 | Brazil |
| Hospital Sirio Libanes; Centro de Oncologia | São Paulo | São Paulo | 01308-050 | Brazil |
| Clinica de Oncologia Medica | São Paulo | São Paulo | 01406100 | Brazil |
| Hospital A. C. Camargo; Oncologia | São Paulo | São Paulo | 01509-010 | Brazil |
| Universidade Federal de Sao Paulo - UNIFESP*X | São Paulo | São Paulo | 22793-080 | Brazil |
| Complex Oncological Center - Plovdiv, EOOD | Plovdiv | 4004 | Bulgaria |
| MHAT Serdika | Sofia | 1301 | Bulgaria |
| SHATOD Dr. Marko Antonov Markov-Varna, EOOD; Department of Medicinall Onchotherapy and Palliative | Varna | 9010 | Bulgaria |
| Health Sciences North | Greater Sudbury | Ontario | P3E 5J1 | Canada |
| Hamilton Health Sciences - Juravinski Cancer Centre | Hamilton | Ontario | L8V 5C2 | Canada |
| London Regional Cancer Centre | London | Ontario | N6A 4L6 | Canada |
| Toronto East General Hospital; Haematology/Oncology | Toronto | Ontario | M4C 3E7 | Canada |
| Sunnybrook Health Science Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Mount Sinai Hospital; Oncology | Toronto | Ontario | M5G 1X5 | Canada |
| McGill University; Glen Site; Oncology | Montreal | Quebec | H4A 3J1 | Canada |
| Cancer Hospital Chinese Academy of Medical Sciences. | Beijing | 100021 | China |
| The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA) | Beijing | 100071 | China |
| Beijing Cancer Hospital | Beijing | 100142 | China |
| the First Hospital of Jilin University | Changchun | 130021 | China |
| Jilin Cancer Hospital | Changchun | 132013 | China |
| Changzhou First People's Hospital | Changzhou | 213003 | China |
| Third Affiliated Hospital of Third Military Medical University | Chongqing | 400042 | China |
| Fuzhou General Hospital, PLA Nanjing Military Area Command | Fuzhou | 110016 | China |
| Sun Yet-sen University Cancer Center | Guangzhou | 510060 | China |
| Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University | Hangzhou | 310016 | China |
| Harbin Medical University Cancer Hospital | Harbin | 150081 | China |
| The 1st Affiliated Hospital of Nanchang Unversity | Nanchang | 330006 | China |
| The 81st Hospital of P.L.A. | Nanjing | 210002 | China |
| Affiliated Hospital of Nantong University | Nantong | 226001 | China |
| Zhongshan Hospital Fudan University | Shanghai | 200032 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200120 | China |
| General Hospital of Shenyang Military Command of PLA | Shenyang | 110016 | China |
| Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province) | Shijiazhuang | 050035 | China |
| The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital) | Xi'an | 710032 | China |
| The Affiliated Hospital of Xuzhou Medical College | Xuzhou | 221000 | China |
| Henan Cancer Hospital | Zhengzhou | 450008 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | 450052 | China |
| Clinical Hospital Centre Zagreb | Zagreb | 10000 | Croatia |
| Clinical Hospital Sisters of Mercy | Zagreb | 10000 | Croatia |
| Hospital Oncologia; Oncology | San Salvador | 01101 | El Salvador |
| Docrates Cance Center | Helsinki | 00180 | Finland |
| Turku Uni Central Hospital; Oncology Clinics | Turku | 20520 | Finland |
| Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo. | Berlin | 10117 | Germany |
| Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung | Essen | 45122 | Germany |
| Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Internistische Onkologie / Haematologie | Essen | 45136 | Germany |
| Klinik Esslingen; Klinik für Allgemeine Innere Medizin, Onkologie/Haematologie | Esslingen am Neckar | 73730 | Germany |
| Universitätsklinikum Hamburg-Eppendorf; Hubertus Wald Tumorzentrum | Hamburg | 20246 | Germany |
| Universitaetsklinikum Leipzig, Universitaeres Krebszentrum Leipzig (UCCL) | Leipzig | 04103 | Germany |
| Klinikum Ludwigsburg; Studiensekretariat | Ludwigsburg | 71640 | Germany |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz; II. Medizinische Klinik | Mainz | 55131 | Germany |
| Universitätsklinikum Mannheim, Tagestherapiezentrum, Interdisziplinäres Tumorzentrum | Mannheim | 68167 | Germany |
| Philipps-Universität Marburg; Klinik für Innere Med.; Schwerpunkt Hämatologie/Onkologie/Immunologie | Marburg | 35043 | Germany |
| Universitätsklinikum Ulm; Zentrum für Innere Medizin Klinik für Innere Medizin I | Ulm | 89081 | Germany |
| Medical Solution; Hematology | Guatemala City | 01-010 | Guatemala |
| Semmelweis Egyetem Onkologiai Központ | Budapest | 1083 | Hungary |
| Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly | Budapest | 1122 | Hungary |
| Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika | Debrecen | 4032 | Hungary |
| Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz;Sugarterapias Klinikai Onkologiai Intez | Miskolc | 3526 | Hungary |
| Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika | Szeged | 6720 | Hungary |
| Ospedale Casa Sollievo Della Sofferenza IRCCS | San Giovanni Rotondo | Apulia | 71013 | Italy |
| Seconda Universita' Degli Studi; Divsione Di Oncologia Medica | Naples | Campania | 80131 | Italy |
| Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica | Bologna | Emilia-Romagna | 40138 | Italy |
| AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia | Reggio Emilia | Emilia-Romagna | 42100 | Italy |
| Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia | Udine | Friuli Venezia Giulia | 33100 | Italy |
| Policlinico Universitario Agostino Gemelli | Rome | Lazio | 00168 | Italy |
| Asst Papa Giovanni XXIII; Oncologia Medica | Bergamo | Lombardy | 24127 | Italy |
| Irccs Ospedale San Raffaele | Milan | Lombardy | 20132 | Italy |
| Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica | Milan | Lombardy | 20141 | Italy |
| Ospedali Riuniti Di Ancona; Oncology | Ancona | The Marches | 60121 | Italy |
| Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2 | Pisa | Tuscany | 56100 | Italy |
| Ospedale Misericordia E Dolce; Oncologia Medica | Prato | Tuscany | 59100 | Italy |
| Aichi Cancer Center Hospital; Clinical Oncology | Aichi | 464-8681 | Japan |
| Nagoya university Hospital; Gastroenterological Surgery 2 | Aichi | 466-8560 | Japan |
| National Cancer Center Hospital East; Gastroenterology | Chiba | 277-8577 | Japan |
| National Hospital Organization Shikoku Cancer Center; Gastroenterology | Ehime | 791-0280 | Japan |
| Kyushu University Hospital; Surgery and Science | Fukuoka | 812-8582 | Japan |
| Gifu University Hospital; Digestive Surgery | Gifu | 501-1194 | Japan |
| Hiroshima City Hiroshima Citizens Hospital; Surgery | Hiroshima | 730-8518 | Japan |
| Kobe city Medical center General Hospital; Medical Oncology | Hyōgo | 650-0047 | Japan |
| St.Marianna University School of Medicine hospital; Medical Oncology | Kanagawa | 216-8511 | Japan |
| Kanagawa Cancer Center; Gastrointestinal Surgery | Kanagawa | 241-8515 | Japan |
| Osaka International Cancer Institute;; Medical oncology and Gastrointestinal oncology | Osaka | 541-8567 | Japan |
| Osaka General Medical Center; Gastroenterological Surgery | Osaka | 558-8558 | Japan |
| Saitama Cancer Center; Gastroenterology | Saitama | 362-0806 | Japan |
| National Cancer Center Hospital; Gastrointestinal Oncology | Tokyo | 104-0045 | Japan |
| Toyama University Hospital;Gastroenterology and Hematology | Toyama | 930-0194 | Japan |
| Kazakh Scientific Research Institution Of Oncology and Radiology; Chemotherapy department | Almaty | 050022 | Kazakhstan |
| Hospital Universiti Sains Malaysia [Neurology] | Kubang Kerian | Kelantan | 16150 | Malaysia |
| Hospital Wanita dan Kanak-Kanak Sabah | Sabah | Sabah | 88996 | Malaysia |
| Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi | Kuala Lumpur | 50586 | Malaysia |
| University Malaya Medical Centre; Clinical Oncology Unit, | Kuala Lumpur | 59100 | Malaysia |
| Hospital Angeles Metropolitano; Room 220 | Mexico City | Mexico CITY (federal District) | 06760 | Mexico |
| Inst. Nacional de Cancerologia; Investigacion Clinica | Mexico City | 14000 | Mexico |
| Oaxaca Site Management Organization | Oaxaca City | 68000 | Mexico |
| Academisch Medisch Centrum Universiteit Amsterdam | Amsterdam | 1105 AZ | Netherlands |
| Clinical Hospital; Oncology Department | Bitola | 7000 | North Macedonia |
| University Clinic for Radiotherapy and Oncology | Skopje | 1000 | North Macedonia |
| Medical Research Centre | Panama City | Panama |
| Centro Medico Monte Carmelo | Arequipa | 04001 | Peru |
| Hospital Sabogal; Oncology | Callao | 02 | Peru |
| Hosp Nacion Edgardo Rebagliati; Oncologia Medica | Jesus Maria | Lima 11 | Peru |
| Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional | Lima | Lima 41 | Peru |
| Clinica San Borja | Lima | Lima 41 | Peru |
| Bialostockie Ctr Onkologii; Oddzial Chemioterapii Dziennej | Bialystok | 15-027 | Poland |
| Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny | Brzozów | 36-200 | Poland |
| Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii | Bydgoszcz | 85-796 | Poland |
| Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii | Krakow | 30-688 | Poland |
| SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego | Opole | 45-060 | Poland |
| NZOZ Centrum Medyczne HCP Sp. z o.o. | Poznan | 61-485 | Poland |
| Wojewódzki Szpital Specjalistyczny Nr 3 | Rybnik | 44-200 | Poland |
| Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Klinika Gastroenterologii Onkologicznej | Warsaw | 02-781 | Poland |
| Cardiomed Medical Center | Cluj-Napoca | 400015 | Romania |
| Oncology Center Sf. Nectarie | Craiova | 200347 | Romania |
| Euroclinic Center of Oncology SRL | Iași | 700106 | Romania |
| Clinical Oncology Dispensary of Ministry of Health of Tatarstan | Kazan' | 420029 | Russia |
| Clinical Oncology Dispensary; Chemotherapy | Omsk | 644013 | Russia |
| SBI for HPE "Ryazan State Medical University n.a. I.P. Pavlov" of MoH of RF | Ryazan | 390011 | Russia |
| SBI of Healthcare Samara Regional Clinical Oncology Dispensary | Samara | 443031 | Russia |
| Kyungpook National University Medical Center | Daegu | 41404 | South Korea |
| Samsung Medical Center | Seoul | (0)6351 | South Korea |
| Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology | Seoul | 03080 | South Korea |
| Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology | Seoul | 03722 | South Korea |
| Asan Medical Center; Medical Oncology | Seoul | 05505 | South Korea |
| Seoul St Mary's Hospital | Seoul | 06591 | South Korea |
| Hospital General Universitario de Elche; Servicio de Oncologia | Elche | Alicante | 03203 | Spain |
| Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia | Badalona | Barcelona | 08916 | Spain |
| Hospital Universitario Reina Sofia; Servicio de Oncologia | Córdoba | Cordoba | 14004 | Spain |
| Hospital del Mar; Servicio de Oncologia | Barcelona | 08003 | Spain |
| Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona | 08035 | Spain |
| Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia | Barcelona | 08041 | Spain |
| Hospital Duran i Reynals; Oncologia | Barcelona | 08907 | Spain |
| Hospital Ramon y Cajal; Servicio de Oncologia | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | 28041 | Spain |
| CHUV; Departement d'Oncologie | Lausanne | 1011 | Switzerland |
| Luzerner Kantonsspital; Medizinische Onkologie | Lucerne | 6004 | Switzerland |
| Taichung Veterans General Hospital; Dept of Surgery | Taichung | 407 | Taiwan |
| National Cheng Kung University Hospital; Oncology | Tainan | 00704 | Taiwan |
| National Taiwan Uni Hospital; Dept of Oncology | Taipei | 100 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
| Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology | Taoyuan | 333 | Taiwan |
| Rajavithi Hospital; Division of Medical Oncology | Bangkok | 10400 | Thailand |
| Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc | Bangkok | 10400 | Thailand |
| Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology | Bangkok | 10700 | Thailand |
| Khonkaen Hospital | Khonkaen | 40000 | Thailand |
| Songklanagarind Hospital; Department of Oncology | Songkhla | 90110 | Thailand |
| Ankara Uni School of Medicine; Medical Oncology | Ankara | 06590 | Turkey (Türkiye) |
| Akdeniz University Medical Faculty; Medical Oncology Department | Antalya | 07070 | Turkey (Türkiye) |
| Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department | Edirne | 22770 | Turkey (Türkiye) |
| Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department | Erzurum | 25240 | Turkey (Türkiye) |
| Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology | Istanbul | 34300 | Turkey (Türkiye) |
| TC Necmettin Erbakan University Meram Medical Faculty Hospital | Konya | 42080 | Turkey (Türkiye) |
| Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department | Malatya | 44280 | Turkey (Türkiye) |
| Derived |
| 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. |
| 31183514 | Derived | 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. |
| 30217672 | Derived | 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. |
| FG001 | Placebo + Trastuzumab + Chemotherapy | Participants received 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 continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason. |
|
| Did Not Receive Any Study Treatment |
|
| Received at Least One Dose of Pertuzumab | Pertuzumab Safety Population |
|
| Received Placebo (No Pertuzumab) | Placebo Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Intent-to-Treat (ITT) population included all randomized participants regardless of whether treatment was actually received, with participants grouped according to the treatment assigned at randomization.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pertuzumab + Trastuzumab + Chemotherapy | Participants received 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 continued to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason. |
| BG001 | Placebo + Trastuzumab + Chemotherapy | Participants received 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 continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Geographic Region | Participants were stratified at randomization according to geographic region, prior gastrectomy, and HER2 status. | Count of Participants | Participants |
| |||||||||||||||
| Prior Gastrectomy | Participants were stratified at randomization according to geographic region, prior gastrectomy, and HER2 status. | Count of Participants | Participants |
| |||||||||||||||
| Human Epidermal Growth Factor Receptor 2 (HER2) Status | Participants were stratified at randomization according to geographic region, prior gastrectomy, and HER2 status. HER2 positivity of tumor specimens from each participant were determined by central laboratory testing. The IHC gives a score of 0 to 3+ that measures the amount of HER2 proteins on the surface of cells. A participant's cancer was considered HER2-positive with an IHC score of 2+ that was confirmed by ISH positivity or by an IHC score of 3+. IHC = immunohistochemistry; ISH = in-situ hybridization | Count of Participants | Participants |
| |||||||||||||||
| Measurability of Disease, per RECIST v1.1 | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The intent-to-treat (ITT) population included all randomized participants, regardless of whether study medication was received. | Posted | Median | 95% Confidence Interval | Months | 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) |
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| Secondary | 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. | The ITT population included all randomized participants, regardless of whether study medication was received. | Posted | Median | 95% Confidence Interval | months | 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) |
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| Secondary | 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. | The subset of participants with measurable disease at baseline, according to RECIST v1.1 criteria. | Posted | Number | 95% Confidence Interval | Percentage of participants | 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) |
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| Secondary | 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. | The subset of participants with measurable disease at baseline, according to RECIST v1.1 criteria. | Posted | Number | 95% Confidence Interval | Percentage of participants | 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) |
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| Secondary | 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. | The participants with measurable disease at baseline who achieved a documented objective response, according to RECIST v1.1 criteria. | Posted | Median | 95% Confidence Interval | months | 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) |
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| Secondary | 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. | The subset of participants with measurable disease at baseline, according to RECIST v1.1 criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | 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) |
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| Secondary | 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. | The safety population included all participants who received any amount of any study medication. Those who received any amount of pertuzumab were included in the pertuzumab arm; all other treated participants were included in the placebo arm. | Posted | Count of Participants | Participants | From Baseline until end of post-treatment follow-up (up to 70 months) |
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| Secondary | 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. | The safety population included all participants who received any amount of any study medication. Those who received any amount of pertuzumab were included in the pertuzumab arm; all other treated participants were included in the placebo arm. | Posted | Count of Participants | Participants | From Baseline until end of post-treatment follow-up (up to 70 months) |
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| Secondary | 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). | Participants in the ITT population (includes all randomized participants, regardless of whether study medication was received) with both a baseline assessment and at least 1 post-treatment assessment are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | 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) |
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| Secondary | 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). | Participants in the ITT population (includes all randomized participants, regardless of whether study medication was received) with both a baseline assessment and at least 1 post-treatment assessment are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | 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) |
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| Secondary | Maximum Serum Concentration (Cmax) of Pertuzumab | The pharmacokinetic analysis included all participants who were treated with study medication and who had at least one measurable concentration of pertuzumab or trastuzumab. In this analysis, results are reported only for evaluable participants who received pertuzumab. | Posted | Mean | Standard Deviation | micrograms per milliliter (μg/mL) | 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) |
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| Secondary | Cmax of Trastuzumab | The pharmacokinetic analysis included all participants who were treated with study medication and who had at least one measurable concentration of pertuzumab or trastuzumab. Data are reported for evaluable participants. | Posted | Mean | Standard Deviation | μg/mL | 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) |
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| Secondary | Minimum Serum Concentration (Cmin) of Pertuzumab | The pharmacokinetic analysis included all participants who were treated with study medication and who had at least one measurable concentration of pertuzumab or trastuzumab. In this analysis, results are reported only for evaluable participants who received pertuzumab. | Posted | Mean | Standard Deviation | μg/mL | Pre-dose (0-6 hours before infusion) on Day 1 of Cycles 1, 2, 3, 4, 6, and 8 (1 cycle = 21 days) |
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| Secondary | Cmin of Trastuzumab | The pharmacokinetic analysis included all participants who were treated with study medication and who had at least one measurable concentration of pertuzumab or trastuzumab. Data are reported for evaluable participants. | Posted | Mean | Standard Deviation | μg/mL | Pre-dose (0-6 hours before infusion) on Day 1 of Cycles 1, 2, 3, 4, 6, and 8 (1 cycle = 21 days) |
|
From Baseline until end of post-treatment follow-up (up to 70 months)
All adverse events (AEs) that occurred during the study and until the post-treatment safety follow-up visit approximately 28 days after last study medication were to be recorded. The safety population included all participants who received any amount of any study medication: those who received any amount of pertuzumab were included in the pertuzumab arm; all other treated participants were included in the placebo arm.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pertuzumab + Trastuzumab + Chemotherapy | Participants received 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 continued to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason. | 299 | 385 | 178 | 385 | 373 | 385 |
| EG001 | Placebo + Trastuzumab + Chemotherapy | Participants received 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 continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason. | 318 | 388 | 156 | 388 | 376 | 388 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Atrial septal defect acquired | Cardiac disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Cardiac ventricular thrombosis | Cardiac disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Intracardiac thrombus | Cardiac disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Prinzmetal angina | Cardiac disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Autoimmune thyroiditis | Endocrine disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Pseudoaldosteronism | Endocrine disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
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| Duodenal stenosis | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Gastric perforation | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Gastric stenosis | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Gastrointestinal ulcer | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Intestinal mass | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Oesophageal haemorrhage | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Biliary sepsis | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Pneumonia Klebsiella | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Anastomotic stenosis | Injury, poisoning and procedural complications | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Rectosigmoid cancer stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Second primary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Anticholinergic syndrome | Nervous system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Haemodynamic instability | Vascular disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Iliac artery occlusion | Vascular disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Gastric pneumatosis | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Mechanical ileus | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Biopsy bone marrow | Investigations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA, Version 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA, Version 22.1 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA, Version 22.1 | Systematic Assessment |
|
The study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but only after the first publication or presentation that involves the overall study. The Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D000069287 | Capecitabine |
| D002945 | Cisplatin |
| C485206 | pertuzumab |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Japan |
|
| North America/Western Europe/Australia |
|
| South America/Eastern Europe |
|
| No Prior Gastrectomy |
|
| IHC 3+ |
|
| Non-Measurable Evaluable Disease Only |
|
The study was designed to have 80% power to show a significant difference with respect to the primary endpoint. |
| Final Analysis | Hazard Ratio (HR) | 0.85 | 2-Sided | 95 | 0.72 | 0.99 | HR was calculated as pertuzumab arm vs. placebo arm. Stratified analysis by geographic region, HER2 status, and prior gastrectomy. | Other | Exploratory |
| OG001 | Placebo + Trastuzumab + Chemotherapy | Participants received 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 continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason. |
|
|
|
| OG001 | Placebo + Trastuzumab + Chemotherapy | Participants received 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 continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason. |
|
|
|
| OG001 | Placebo + Trastuzumab + Chemotherapy | Participants received 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 continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason. |
|
|
|
| OG001 | Placebo + Trastuzumab + Chemotherapy | Participants received 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 continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason. |
|
|
|
| OG001 | Placebo + Trastuzumab + Chemotherapy | Participants received 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 continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason. |
|
|
|
| OG001 |
| Placebo + Trastuzumab + Chemotherapy |
Participants received 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 continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason. |
|
|
|
|
| OG001 | Placebo + Trastuzumab + Chemotherapy | Participants received 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 continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason. |
|
|
| OG001 | Placebo + Trastuzumab + Chemotherapy | Participants received 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 continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason. |
|
|
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| Participants |
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| Participants |
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