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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and overPharmaceutical / IndustryBO25114
NCT01774786

Trial Description

Summary

This double-blind, placebo-controlled, randomized, multicenter, international, p arallel arm study will evaluate the efficacy and safety of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab), fluoropyrimidine and cisplatin as f irst-line treatment in patients with HER2-positive metastatic gastroesophageal j unction or gastric cancer. Patients will be randomized to receive Perjeta 840 mg or placebo intravenously (iv) every 3 weeks in combination with Herceptin (init ial dose of 8 mg/kg iv followed by 6 mg/kg iv every 3 weeks) and cisplatin and f luoropyrimidine (capecitabine or 5-fluorouracil) for the first 6 treatment cycle s. Patients will continue to receive Perjeta or placebo and Herceptin until dise ase progression or unacceptable toxicity occurs.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

F. Hoffmann - La Roche, Limited

Clinical TrialsStudy Director

Reference Study ID Number: BO25114 www.roche.com/about_roche/roche_worldwide.htmPh: 888-662-6728 (U.S. Only)
  Email: global.rochegenentechtrials@roche.com

Trial Sites

U.S.A.
Colorado
  Denver
 Study Site
Florida
  Orlando
 Study Site
  St.Petersburg
 Study Site
Indiana
  Goshen
 Study Site
Minnesota
  Minneapolis
 Study Site
Nevada
  Las Vegas
 Study Site
New York
  Albany
 Study Site
  Fresh Meadows
 Study Site
Ohio
  Cincinnati
 Study Site
South Carolina
  Charleston
 Study Site
Virginia
  Fairfax
 Study Site
Australia
  Perth
 Study Site
Queensland
  Herston
 Study Site
Victoria
  East Bentleigh
 Study Site
  Heidelberg
 Study Site
Austria
  Salzburg
 Study Site
  Zams
 Study Site
Belgium
  Bruxelles
 Study Site
Brazil
  Florianopolis
 Study Site
  Porto Alegre
 Study Site
  Rio De Janeiro
 Study Site
Sao Paulo
  Sao Paulo
 Study Site
Canada
Newfoundland and Labrador
  St. John's
 Study Site
Ontario
  Sudbury
 Study Site
  Toronto
 Study Site
Quebec
  Montreal
 Study Site
China
  Beijing
 Study Site
  Changchun
 Study Site
  ChongQing
 Study Site
  Guangzhou
 Study Site
  Hangzhou
 Study Site
  Harbin
 Study Site
  Nanchang
 Study Site
  Nanjing
 Study Site
  Nantong
 Study Site
  Shenyang
 Study Site
  Zhengzhou
 Study Site
Croatia
  Zagreb
 Study Site
El Salvador
  Salvador
 Study Site
Finland
  Helsinki
 Study Site
Germany
  Berlin
 Study Site
  Essen
 Study Site
  Esslingen
 Study Site
  Mainz
 Study Site
  Mannheim
 Study Site
Guatemala
  Guatemala
 Study Site
Hungary
  Budapest
 Study Site
  Miskolc
 Study Site
Italy
  Bergamo
 Study Site
  Catanzaro
 Study Site
  Genova
 Study Site
  Milano
 Study Site
  Napoli
 Study Site
  Prato
 Study Site
  Reggio Emilia
 Study Site
  Roma
 Study Site
  San Giovanni Rotondo
 Study Site
  Udine
 Study Site
Japan
  Aichi
 Study Site
  Fukuoka
 Study Site
  Hiroshima
 Study Site
  Hyogo
 Study Site
  Kanagawa
 Study Site
  Osaka
 Study Site
  Toyama
 Study Site
Macedonia
  Bitola
 Study Site
Malaysia
  Kuala Lumpur
 Study Site
  Sabah
 Study Site
Mexico
  Mexico City
 Study Site
Panama
  Panama
 Study Site
Peru
  Arequipa
 Study Site
  Callao
 Study Site
  Lima
 Study Site
  Miraflores
 Study Site
Poland
  Bydgoszcz
 Study Site
  Krakow
 Study Site
  Poznan
 Study Site
  Rybnik
 Study Site
  Warszawa
 Study Site
Republic of Bulgaria
  Varna
 Study Site
Republic of Korea
  Daegu
 Study Site
  Seoul
 Study Site
Romania
  Bucharest
 Study Site
  Cluj-Napoca
 Study Site
  Craiova
 Study Site
  Iasi
 Study Site
Russia
  Kazan
 Study Site
  Omsk
 Study Site
  Ryazan
 Study Site
  Samara
 Study Site
Spain
  Barcelona
 Study Site
  Cordoba
 Study Site
  Elche
 Study Site
  Madrid
 Study Site
Switzerland
  Lausanne
 Study Site
Taiwan
  Taichung
 Study Site
  Tainan
 Study Site
  Taipei
 Study Site
  Taoyuan
 Study Site
Thailand
  Bangkok
 Study Site
  Khonkaen
 Study Site
  Patumwan
 Study Site
  Songkhla
 Study Site
Turkey
  Antalya
 Study Site
  Edirne
 Study Site
  Istanbul
 Study Site
  Malatya
 Study Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01774786
ClinicalTrials.gov processed this data on August 26, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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