Clinical Trial Protocol Registry

Trial information

A Study of Perjeta (Pertuzumab) in Combination with Herceptin (Trastuzumab) and Chemotherapy in Patients with HER2-Positive Metastatic Gastroesophageal Junction or Gastric Cancer

Status:
Recruiting
Protocol number:
BO25114
Sponsor:
Hoffmann-La Roche
Company division:
Pharmaceutical
Product name:
PERJETA
Generic name:
PERTUZUMAB
Official Scientific Title:
A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER PHASE III STUDY EVALUATING THE EFFICACY AND SAFETY OF PERTUZUMAB IN COMBINATION WITH TRASTUZUMAB AND CHEMOTHERAPY IN PATIENTS WITH HER2-POSITIVE METASTATIC GASTROESOPHAGEAL JUNCTION OR GASTRIC CANCER
Brief summary:
This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm study will evaluate the efficacy and safety of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab), fluoropyrimidine and cisplatin as first-line treatment in patients with HER2-positive metastatic gastroesophageal junction or gastric cancer. Patients will be randomized to receive Perjeta 840 mg or placebo intravenously (iv) every 3 weeks in combination with Herceptin (initial dose of 8 mg/kg iv followed by 6 mg/kg iv every 3 weeks) and cisplatin and fluoropyrimidine (capecitabine or 5-fluorouracil) for the first 6 treatment cycles. Patients will continue to receive Perjeta or placebo and Herceptin until disease progression or unacceptable toxicity occurs. Target sample size is 780.
Study phase:
III
Study type:
Interventional; Treatment; Randomized; Double Blind; Parallel; Safety/efficacy study
Conditions:
  • Gastric Cancer
Primary outcome:
  1. Overall survival: Time from randomization to death of any cause Time frame: approximately 4.5 years
Key secondary outcomes:
  1. Progression-free survival: Time from randomization to first occurrence of disease progression, as determined by the investigator according to RECIST v1.1 criteria, or death of any cause Time frame: approximately 4.5 years
  2. Overall objective response (partial response + complete response) occurring on two consecutive occasions >/= 4 weeks apart, as determined by the investigator according to RECIST v1.1 criteria Time frame: approximately 4.5 years
  3. Duration of objective response: Time from occurrence of objective response to progressive disease, as determined by investigator according to RECIST v1.1 criteria, or death of any cause Time frame: approximately 4.5 years
  4. Clinical benefit rate: Best response of complete response or partial response or stable disease for 6 weeks or longer, as determined by the investigator according to RECIST v1.1 criteria Time frame: approximately 4.5 years
  5. Safety: Incidence of adverse events Time frame: approximately 4.5 years
  6. Safety: Incidence of left ventricular systolic dysfunction (symptomatic or asymptomatic) Time frame: approximately 4.5 years
Inclusion criteria:
  • Adult patients, >/= 18 years of age
  • HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction
  • 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 >/= 3 months
Exclusion criteria:
  • Previous cyctotoxic 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 peripheral bone metastases, if recovered from all toxicities)
  • History or evidence of brain metastases
  • Clinically significant active GI bleeding (Grade >/= 2 according to NIC-CTCAEv.4.03)
  • Other malignancy (in addition to 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 < 55%
  • Any significant uncontrolled intercurrent systemic illness
  • Positive for hepatitis B, hepatitis C or HIV infection
Gender:
Males or Females
Age limits:
Min: 18 years Max: N/A (No limit)
Accepts healthy volunteers:
No
Anticipated start date:
June, 2013
Trial registration date:
10.01.2013
Date last updated:
22.09.2014
This trial is being conducted at the following locations:
Australia
  • EAST BENTLEIGH
  • PERTH
AUSTRALIA
  • Herston, Queen
  • Heidelberg, Victo
Austria
  • ZAMS
AUSTRIA
  • Salzburg
Belgium
  • BRUXELLES
  • LEUVEN
Brazil
  • PORTO ALEGRE
  • RIO DE JANEIRO
  • SAO PAULO
BRAZIL
  • Porto Alegre, RS
  • Florianopolis, SC
  • Sao Paulo, SP
BULGARIA
  • Plovdiv
  • Sofia
  • Varna
Canada
  • ST. JOHN'S, NL
  • HAMILTON, ON
  • TORONTO, ON
  • MONTREAL, QC
CANADA
  • Sudbury, Ontar
  • TORONTO, Ontar
China
  • BEIJING
  • CHONGQING
  • GUANGZHOU
  • NANJING
  • SHANGHAI
CHINA
  • Beijing
  • Changchun
  • CHANGCHUN
  • Changzhou City
  • Fuzhou
  • HANGZHOU
  • Harbin
  • Nanchang
  • Nantong
  • Shanghai
  • SHANGHAI
  • Shenyang
  • Shijiazhuang
  • Xi'an
  • Xuzhou
  • Zhengzhou
Croatia
  • ZAGREB
CROATIA
  • Osijek
  • Zagreb
EL SALVADOR
  • Salvador
Finland
  • TURKU
FINLAND
  • Helsinki
France
  • CRETEIL
  • PARIS
  • REIMS
  • SAINT HERBLAIN
  • VILLEJUIF
FRANCE
  • Brest
  • Montpellier
  • Paris
  • PARIS
Germany
  • BERLIN
  • ESSEN
  • ESSLINGEN
  • MAINZ
GERMANY
  • Essen
  • Hamburg
  • Leipzig
  • Ludwigsburg
  • Mannheim
  • Marburg
  • Ulm
GUATEMALA
  • Guatemala
Hungary
  • DEBRECEN
  • SZEGED
HUNGARY
  • Budapest
  • MISKOLC
Italy
  • ANCONA
  • GENOVA
  • UDINE
ITALY
  • CATANZARO, Calab
  • NAPOLI, Campa
  • BOLOGNA, Emili
  • Reggio Emilia, Emili
  • ROMA, Lazio
  • BERGAMO, Lomba
  • MILANO, Lomba
  • San Giovanni Rotondo, Pugli
  • Pisa, Tosca
  • Prato, Tosca
Japan
  • CHIBA
  • SAITAMA
JAPAN
  • Aichi
  • AICHI
  • Ehime
  • Fukuoka
  • GIFU
  • Hiroshima
  • Hyogo
  • Kanagawa
  • Osaka
  • Tokyo
  • Toyama
KAZAKHSTAN
  • Almaty
KOREA, REPUBLIC OF
  • Seoul
MACEDONIA
  • Bitola
  • SKOPJE
MALAYSIA
  • Kota Bharu Kelantan
  • Kuala Lumpur
  • Sabah
Mexico
  • MEXICO CITY
MEXICO
  • MEXICO CITY
  • Oaxaca
NETHERLANDS
  • Amsterdam
PANAMA
  • Panama
Peru
  • CALLAO
PERU
  • Arequipa
  • Jesus Maria
  • Lima
  • LIMA
  • Miraflores
  • Piura
Poland
  • WARSZAWA
POLAND
  • BIALYSTOK
  • Brzozów
  • BYDGOSZCZ
  • Dabrowa Górnicza
  • Krakow
  • Opole
  • Poznan
  • Rybnik
  • Wroclaw
Republic of Korea
  • DAEGU
  • SEOUL
ROMANIA
  • BUCHAREST
  • Cluj-Napoca
  • Craiova
  • Iasi
Russian Federation
  • RYAZAN
RUSSIAN FEDERATION
  • KAZAN
  • Omsk
  • Rostov-on-Don
  • Samara
Spain
  • BARCELONA
  • CORDOBA
  • ELCHE
SPAIN
  • Barcelona, BARCE
  • Madrid, MADRI
Switzerland
  • ZÜRICH
SWITZERLAND
  • Lausanne
  • Luzern
Taiwan
  • TAICHUNG
  • TAIPEI
TAIWAN
  • Tainan
  • Taipei
  • Taoyuan
THAILAND
  • Bangkok
  • BANGKOK
  • Khonkaen
  • Patumwan
  • SONGKHLA
TURKEY
  • ANKARA
  • Antalya
  • EDIRNE
  • ERZURUM
  • ISTANBUL
  • Konya
  • MALATYA
U.S.A.
  • FRESH MEADOWS, NY
  • EDMONDS, WA
UNITED STATES
  • Stanford, CA
  • Denver, CO
  • Fort Myers, FL
  • Orlando, FL
  • St.Petersburg, FL
  • CHICAGO, IL
  • Goshen, IN
  • Minneapolis, MN
  • Las Vegas, NV
  • Albany, NY
  • New York, NY
  • Cincinnati, OH
  • Charleston, SC
  • Nashville, TN
  • LEWISVILLE, TX
  • Paris, TX
  • Tyler, TX
  • Fairfax, VA
  • Tacoma, WA

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