A Study of Perjeta (Pertuzumab) in Combination With Herceptin (Trastuzumab) and Chemotherapy in Patients With HER2-Positive Metastatic Gastroesophageal Junction or Gastric Cancer
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Intervention
Name: 5-fluorouracil Type: Drug
Name: capecitabine Type: Drug
Name: cisplatin Type: Drug
Name: pertuzumab [Perjeta] Type: Drug
Name: placebo Type: Drug
Name: trastuzumab [Herceptin] Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Stanford, California, United States
Status: Recruiting
Denver, Colorado, United States
Status: Terminated
Fort Myers, Florida, United States
Status: Recruiting
Orlando, Florida, United States
Status: Active, not recruiting
St.Petersburg, Florida, United States
Status: Recruiting
Chicago, Illinois, United States
Status: Active, not recruiting
Goshen, Indiana, United States
Status: Recruiting
Minneapolis, Minnesota, United States
Status: Terminated
Las Vegas, Nevada, United States
Status: Recruiting
Albany, New York, United States
Status: Recruiting
Fresh Meadows, New York, United States
Status: Recruiting
New York, New York, United States
Status: Recruiting
Cincinnati, Ohio, United States
Status: Recruiting
Charleston, South Carolina, United States
Status: Recruiting
Nashville, Tennessee, United States
Status: Recruiting
Lewisville, Texas, United States
Status: Terminated
Paris, Texas, United States
Status: Terminated
Tyler, Texas, United States
Status: Terminated
Fairfax, Virginia, United States
Status: Terminated
Edmonds, Washington, United States
Status: Terminated
Tacoma, Washington, United States
Status: Terminated
Herston, Queensland, Australia
Status: Recruiting
East Bentleigh, Victoria, Australia
Status: Recruiting
Heidelberg, Victoria, Australia
Status: Recruiting
Perth, Western Australia, Australia
Status: Recruiting
Salzburg, Austria
Status: Recruiting
Zams, Austria
Status: Active, not recruiting
Bruxelles, Belgium
Status: Recruiting
Rio De Janeiro, RJ, Brazil
Status: Recruiting
Porto Alegre, RS, Brazil
Status: Recruiting
Porto Alegre, RS, Brazil
Status: Recruiting
Florianopolis, SC, Brazil
Status: Recruiting
Sao Paulo, SP, Brazil
Status: Recruiting
Sao Paulo, SP, Brazil
Status: Recruiting
Sao Paulo, SP, Brazil
Status: Recruiting
Sao Paulo, SP, Brazil
Status: Recruiting
Plovdiv, Bulgaria
Status: Active, not recruiting
Sofia, Bulgaria
Status: Active, not recruiting
Sofia, Bulgaria
Status: Terminated
Varna, Bulgaria
Status: Recruiting
St. John's, Newfoundland and Labrador, Canada
Status: Terminated
Hamilton, Ontario, Canada
Status: Recruiting
London, Ontario, Canada
Status: Recruiting
Sudbury, Ontario, Canada
Status: Recruiting
Toronto, Ontario, Canada
Status: Recruiting
Toronto, Ontario, Canada
Status: Completed
Toronto, Ontario, Canada
Status: Recruiting
Montreal, Quebec, Canada
Status: Recruiting
Beijing, China
Status: Recruiting
Beijing, China
Status: Recruiting
Beijing, China
Status: Recruiting
Changchun, China
Status: Recruiting
Changchun, China
Status: Recruiting
Changzhou, China
Status: Active, not recruiting
ChongQing, China
Status: Recruiting
Fuzhou, China
Status: Recruiting
Fuzhou, China
Status: Recruiting
Guangzhou, China
Status: Recruiting
Hangzhou, China
Status: Recruiting
Harbin, China
Status: Recruiting
Nanchang, China
Status: Recruiting
Nanjing, China
Status: Recruiting
Nantong, China
Status: Active, not recruiting
Shanghai, China
Status: Recruiting
Shanghai, China
Status: Active, not recruiting
Shenyang, China
Status: Recruiting
Shijiazhuang, China
Status: Recruiting
Xi'an, China
Status: Recruiting
Xuzhou, China
Status: Recruiting
Zhengzhou, China
Status: Recruiting
Zhengzhou, China
Status: Recruiting
Osijek, Croatia
Status: Terminated
Zagreb, Croatia
Status: Recruiting
Zagreb, Croatia
Status: Active, not recruiting
Salvador, El Salvador
Status: Completed
Helsinki, Finland
Status: Recruiting
Turku, Finland
Status: Terminated
Berlin, Germany
Status: Recruiting
Essen, Germany
Status: Recruiting
Essen, Germany
Status: Active, not recruiting
Esslingen, Germany
Status: Completed
Hamburg, Germany
Status: Active, not recruiting
Leipzig, Germany
Status: Recruiting
Ludwigsburg, Germany
Status: Recruiting
Mainz, Germany
Status: Active, not recruiting
Mannheim, Germany
Status: Recruiting
Marburg, Germany
Status: Recruiting
Ulm, Germany
Status: Active, not recruiting
Guatemala, Guatemala
Status: Completed
Budapest, Hungary
Status: Active, not recruiting
Budapest, Hungary
Status: Active, not recruiting
Debrecen, Hungary
Status: Active, not recruiting
Miskolc, Hungary
Status: Recruiting
Szeged, Hungary
Status: Active, not recruiting
Catanzaro, Calabria, Italy
Status: Terminated
Napoli, Campania, Italy
Status: Recruiting
Bologna, Emilia-Romagna, Italy
Status: Completed
Reggio Emilia, Emilia-Romagna, Italy
Status: Recruiting
Udine, Friuli-Venezia Giulia, Italy
Status: Recruiting
Roma, Lazio, Italy
Status: Recruiting
Genova, Liguria, Italy
Status: Terminated
Bergamo, Lombardia, Italy
Status: Recruiting
Milano, Lombardia, Italy
Status: Recruiting
Milano, Lombardia, Italy
Status: Recruiting
Ancona, Marche, Italy
Status: Completed
San Giovanni Rotondo, Puglia, Italy
Status: Recruiting
Pisa, Toscana, Italy
Status: Recruiting
Prato, Toscana, Italy
Status: Recruiting
Aichi, Japan
Status: Completed
Aichi, Japan
Status: Completed
Chiba, Japan
Status: Active, not recruiting
Ehime, Japan
Status: Active, not recruiting
Fukuoka, Japan
Status: Active, not recruiting
Gifu, Japan
Status: Active, not recruiting
Hiroshima, Japan
Status: Active, not recruiting
Hyogo, Japan
Status: Completed
Kanagawa, Japan
Status: Active, not recruiting
Kanagawa, Japan
Status: Completed
Osaka, Japan
Status: Active, not recruiting
Osaka, Japan
Status: Active, not recruiting
Saitama, Japan
Status: Active, not recruiting
Tokyo, Japan
Status: Active, not recruiting
Toyama, Japan
Status: Active, not recruiting
Almaty, Kazakhstan
Status: Active, not recruiting
Almaty, Kazakhstan
Status: Recruiting
Daegu, Korea, Republic of
Status: Active, not recruiting
Seoul, Korea, Republic of
Status: Recruiting
Seoul, Korea, Republic of
Status: Active, not recruiting
Seoul, Korea, Republic of
Status: Recruiting
Seoul, Korea, Republic of
Status: Active, not recruiting
Seoul, Korea, Republic of
Status: Active, not recruiting
Bitola, Macedonia, The Former Yugoslav Republic of
Status: Active, not recruiting
Skopje, Macedonia, The Former Yugoslav Republic of
Status: Active, not recruiting
Kota Bharu Kelantan, Malaysia
Status: Completed
Kuala Lumpur, Malaysia
Status: Recruiting
Kuala Lumpur, Malaysia
Status: Recruiting
Sabah, Malaysia
Status: Recruiting
Mexico City, Mexico
Status: Completed
Mexico City, Mexico
Status: Active, not recruiting
Oaxaca, Mexico
Status: Recruiting
Amsterdam, Netherlands
Status: Recruiting
Panama, Panama
Status: Active, not recruiting
Arequipa, Peru
Status: Recruiting
Callao, Peru
Status: Recruiting
Jesus Maria, Peru
Status: Recruiting
Lima, Peru
Status: Active, not recruiting
Miraflores, Peru
Status: Active, not recruiting
Bialystok, Poland
Status: Recruiting
Brzozów, Poland
Status: Recruiting
Bydgoszcz, Poland
Status: Active, not recruiting
Krakow, Poland
Status: Active, not recruiting
Opole, Poland
Status: Active, not recruiting
Poznan, Poland
Status: Recruiting
Rybnik, Poland
Status: Active, not recruiting
Warszawa, Poland
Status: Active, not recruiting
Wroclaw, Poland
Status: Terminated
Bucharest, Romania
Status: Terminated
Cluj-Napoca, Romania
Status: Active, not recruiting
Cluj-Napoca, Romania
Status: Recruiting
Craiova, Romania
Status: Active, not recruiting
Iasi, Romania
Status: Completed
Kazan, Russian Federation
Status: Recruiting
Omsk, Russian Federation
Status: Active, not recruiting
Rostov-on-Don, Russian Federation
Status: Terminated
Ryazan, Russian Federation
Status: Recruiting
Samara, Russian Federation
Status: Recruiting
Elche, Alicante, Spain
Status: Recruiting
Barcelona, Spain
Status: Recruiting
Barcelona, Spain
Status: Recruiting
Barcelona, Spain
Status: Active, not recruiting
Barcelona, Spain
Status: Active, not recruiting
Barcelona, Spain
Status: Recruiting
Cordoba, Spain
Status: Recruiting
Madrid, Spain
Status: Recruiting
Madrid, Spain
Status: Recruiting
Lausanne, Switzerland
Status: Active, not recruiting
Luzern, Switzerland
Status: Recruiting
Zürich, Switzerland
Status: Terminated
Taichung, Taiwan
Status: Recruiting
Tainan, Taiwan
Status: Recruiting
Taipei, Taiwan
Status: Recruiting
Taipei, Taiwan
Status: Recruiting
Taoyuan, Taiwan
Status: Recruiting
Bangkok, Thailand
Status: Recruiting
Bangkok, Thailand
Status: Recruiting
Khonkaen, Thailand
Status: Recruiting
Patumwan, Thailand
Status: Recruiting
Songkhla, Thailand
Status: Recruiting
Ankara, Turkey
Status: Completed
Antalya, Turkey
Status: Recruiting
Edirne, Turkey
Status: Recruiting
Erzurum, Turkey
Status: Recruiting
Istanbul, Turkey
Status: Recruiting
Konya, Turkey
Status: Completed
Malatya, Turkey
Status: Recruiting
Start Date
June 2013
Completion Date
March 2022
Sponsors
Hoffmann-La Roche
Source
Hoffmann-La Roche
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page