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
- Cancer
- Gastric Cancer
Completed
- Albany
- Almaty
- Amsterdam
- Ancona
- Ankara
- Antalya
- Arequipa
- Badalona
- Barcelona
- bei-jing-shi
- Bellavista
- Bergamo
- Berlin
- Białystok
- Bitola
- Bologna
- Bruxelles
- Brzozów
- Budapest
- Bydgoszcz
- Cercado de Lima
- chang-chun-shi
- chang-zhou-shi
- Charleston
- Chicago
- chong-qing-shi
- Chuo City
- Cincinnati
- Ciudad de México
- Clayton
- Cluj-Napoca
- Craiova
- Córdoba
- Daegu
- Debrecen
- Edirne
- Elche
- Erzurum
- Essen
- Esslingen am Neckar
- Fort Myers
- fu-zhou-shi
- Fukuoka
- Gifu
- Goshen
- greater-sudbury
- guang-zhou-shi
- Guatemala
- Hamburg
- Hamilton
- hang-zhou-shi
- Harbin
- Heidelberg
- Helsinki
- Herston
- Hiroshima
- Iași
- Ina
- İstanbul
- Jesús María
- Kashiwa
- Kawasaki
- Kazan
- Kho Hong
- Khon Kaen
- Kobe
- Konya
- Kota Bharu
- Kota Kinabalu
- Kraków
- Krung Thep Maha Nakhon
- Kuala Lumpur
- L'Hospitalet de Llobregat
- Las Vegas
- Lausanne
- Leipzig
- Lombardia
- London
- Ludwigsburg
- Luzern 16
- Madrid
- Mainz
- Malatya
- Mannheim
- Marburg
- Matsuyama
- Milano
- Miskolc
- Montréal
- México
- Nagoya
- nan-chang-shi
- nan-jing-shi
- nan-tong-shi
- Napoli
- Nashville
- Nedlands
- New York
- Omsk Oblast
- Opole
- Osaka
- Panama City
- Pisa
- Plovdiv
- Poznań
- Prato
- Reggio Emilia
- Rio de Janeiro
- Rio Grande do Sul
- Roma
- Ryazan'
- Rybnik
- Salzburg
- Samara
- San Borja
- San Giovanni Rotondo
- San Salvador
- Santa Catarina
- Seoul
- shang-hai-shi
- shen-yang-shi
- shi-jia-zhuang-shi
- shkupi
- Sofia
- Szeged
- São Paulo
- Taichung City
- Tainan City
- Taipei City
- Taoyuan City
- Toronto
- toyama
- Turku
- Udine
- Ulm
- Varna
- Warszawa
- xi-an-shi
- xu-zhou-shi
- Yokohama
- Zagreb
- zams
- zheng-zhou-shi
NCT01774786 2012-003554-83 BO25114
Trial Summary
This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab, fluoropyrimidine and cisplatin as first-line treatment in participants with HER2-positive metastatic gastroesophageal junction (GEJ) or 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.
A Double-Blind, Placebo-Controlled, Randomized, Multicenter Phase III Study Evaluating the Efficacy and Safety of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Metastatic Gastroesophageal Junction and Gastric Cancer
Eligibility 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
- 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
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