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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01774786
First received: January 21, 2013
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Drug: 5-fluorouracil
Drug: capecitabine
Drug: cisplatin
Drug: pertuzumab [Perjeta]
Drug: placebo
Drug: trastuzumab [Herceptin]
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival: Time from randomization to death of any cause [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of left ventricular systolic dysfunction (symptomatic or asymptomatic) [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 780
Study Start Date: June 2013
Estimated Study Completion Date: March 2022
Estimated Primary Completion Date: March 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pertuzumab + TFP Drug: 5-fluorouracil
800 mg/m2/24 hours iv by continuous infusion for 120 hours (Days 1-5) every 3 weeks, 6 cycles (or capecitabine)
Drug: capecitabine
1000 mg/m2 orally twice daily, evening of Day 1 to morning of Day 15 (28 doses) every 3 weeks, 6 cycles (or 5-fluorouracil)
Drug: cisplatin
80 mg/m2 iv every 3 weeks, 6 cycles
Drug: pertuzumab [Perjeta]
840 mg iv every 3 weeks
Drug: trastuzumab [Herceptin]
8 mg/kg iv initial dose on Day 1, followed by 6 mg/kg iv every 3 weeks
Placebo Comparator: Placebo + TFP Drug: 5-fluorouracil
800 mg/m2/24 hours iv by continuous infusion for 120 hours (Days 1-5) every 3 weeks, 6 cycles (or capecitabine)
Drug: capecitabine
1000 mg/m2 orally twice daily, evening of Day 1 to morning of Day 15 (28 doses) every 3 weeks, 6 cycles (or 5-fluorouracil)
Drug: cisplatin
80 mg/m2 iv every 3 weeks, 6 cycles
Drug: placebo
pertuzumab placebo iv every 3 weeks
Drug: trastuzumab [Herceptin]
8 mg/kg iv initial dose on Day 1, followed by 6 mg/kg iv every 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774786

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

  Hide Study Locations
Locations
United States, Colorado
Recruiting
Denver, Colorado, United States, 80218
United States, Florida
Active, not recruiting
Fort Myers, Florida, United States, 33916
Recruiting
Orlando, Florida, United States, 32804
Recruiting
St.Petersburg, Florida, United States, 33705
United States, Illinois
Active, not recruiting
Chicago, Illinois, United States, 60637
United States, Indiana
Recruiting
Goshen, Indiana, United States, 46526
United States, Minnesota
Recruiting
Minneapolis, Minnesota, United States, 55407
United States, Nevada
Recruiting
Las Vegas, Nevada, United States, 89169
United States, New York
Recruiting
Albany, New York, United States, 12206
Recruiting
Fresh Meadows, New York, United States, 11366
United States, Ohio
Recruiting
Cincinnati, Ohio, United States, 45219
United States, South Carolina
Recruiting
Charleston, South Carolina, United States, 29425
United States, Tennessee
Active, not recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Terminated
Lewisville, Texas, United States, 75067
Terminated
Paris, Texas, United States, 75460
Terminated
Tyler, Texas, United States, 75702
United States, Virginia
Recruiting
Fairfax, Virginia, United States, 22031
United States, Washington
Terminated
Edmonds, Washington, United States, 98026
Terminated
Tacoma, Washington, United States, 98405
Australia, Queensland
Recruiting
Herston, Queensland, Australia, 4029
Australia, Victoria
Recruiting
East Bentleigh, Victoria, Australia, VIC 3165
Recruiting
Heidelberg, Victoria, Australia, 3084
Australia, Western Australia
Recruiting
Perth, Western Australia, Australia, 6009
Austria
Recruiting
Salzburg, Austria, 5020
Recruiting
Zams, Austria, 6511
Belgium
Recruiting
Bruxelles, Belgium, 1200
Not yet recruiting
Leuven, Belgium, 3000
Brazil
Recruiting
Rio De Janeiro, RJ, Brazil, 22290-160
Recruiting
Porto Alegre, RS, Brazil, 90035-003
Recruiting
Porto Alegre, RS, Brazil, 91350-200
Recruiting
Florianopolis, SC, Brazil, 88034-000
Recruiting
Sao Paulo, SP, Brazil, 01406100
Recruiting
Sao Paulo, SP, Brazil, 01509-010
Recruiting
Sao Paulo, SP, Brazil, 22793-080
Recruiting
Sao Paulo, SP, Brazil, 01308-050
Bulgaria
Active, not recruiting
Plovdiv, Bulgaria, 4004
Terminated
Sofia, Bulgaria, 1606
Active, not recruiting
Sofia, Bulgaria, 1301
Recruiting
Varna, Bulgaria, 9010
Canada, Newfoundland and Labrador
Recruiting
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
Active, not recruiting
Hamilton, Ontario, Canada, L8V 5C2
Recruiting
Sudbury, Ontario, Canada, P3E 5J1
Recruiting
Toronto, Ontario, Canada, M4N 3M5
Recruiting
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Recruiting
Montreal, Quebec, Canada, H3G 1A4
China
Not yet recruiting
Beijing, China, 100021
Recruiting
Beijing, China, 100071
Recruiting
Beijing, China, 100142
Recruiting
Changchun, China, 130012
Not yet recruiting
Changchun, China, 130021
Not yet recruiting
Changzhou City, China, 213003
Recruiting
ChongQing, China, 400042
Not yet recruiting
Fuzhou, China, 350025
Not yet recruiting
Fuzhou, China, 350014
Recruiting
Guangzhou, China, 510060
Recruiting
Hangzhou, China, 310016
Recruiting
Harbin, China, 150081
Recruiting
Nanchang, China, 330019
Recruiting
Nanjing, China, 210002
Recruiting
Nantong, China, 226361
Not yet recruiting
Shanghai, China, 200080
Not yet recruiting
Shanghai, China, 200032
Recruiting
Shenyang, China, 110016
Not yet recruiting
Shijiazhuang, China, 050011
Not yet recruiting
Xi'an, China, 710032
Not yet recruiting
Xuzhou, China, 221004
Not yet recruiting
Zhengzhou, China, 450052
Recruiting
Zhengzhou, China, 450008
Croatia
Terminated
Osijek, Croatia, 31000
Recruiting
Zagreb, Croatia, 10000
Active, not recruiting
Zagreb, Croatia, 10000
El Salvador
Recruiting
Salvador, El Salvador, 01101
Finland
Recruiting
Helsinki, Finland, 00180
Active, not recruiting
Turku, Finland, 20520
Germany
Recruiting
Berlin, Germany, 13353
Recruiting
Essen, Germany, 45136
Active, not recruiting
Essen, Germany, 45122
Recruiting
Esslingen, Germany, 73730
Active, not recruiting
Hamburg, Germany, 20246
Active, not recruiting
Leipzig, Germany, 04103
Active, not recruiting
Ludwigsburg, Germany, 71640
Recruiting
Mainz, Germany, 55131
Recruiting
Mannheim, Germany, 68167
Active, not recruiting
Marburg, Germany, 35043
Active, not recruiting
Ulm, Germany, 89081
Guatemala
Recruiting
Guatemala, Guatemala, 01-010
Hungary
Active, not recruiting
Budapest, Hungary, 1122
Recruiting
Budapest, Hungary, 1083
Active, not recruiting
Debrecen, Hungary, 4032
Recruiting
Miskolc, Hungary, 3526
Active, not recruiting
Szeged, Hungary, 6701
Italy
Recruiting
Catanzaro, Calabria, Italy, 88100
Recruiting
Napoli, Campania, Italy, 80131
Completed
Bologna, Emilia-Romagna, Italy, 40138
Recruiting
Reggio Emilia, Emilia-Romagna, Italy, 42100
Recruiting
Udine, Friuli-Venezia Giulia, Italy, 33100
Recruiting
Roma, Lazio, Italy, 00168
Recruiting
Genova, Liguria, Italy, 16132
Recruiting
Bergamo, Lombardia, Italy, 24127
Recruiting
Milano, Lombardia, Italy, 20132
Recruiting
Milano, Lombardia, Italy, 20141
Completed
Ancona, Marche, Italy
Recruiting
San Giovanni Rotondo, Puglia, Italy, 71013
Active, not recruiting
Pisa, Toscana, Italy, 56100
Recruiting
Prato, Toscana, Italy, 59100
Japan
Recruiting
Aichi, Japan, 464-8681
Recruiting
Aichi, Japan, 466-8560
Active, not recruiting
Chiba, Japan, 277-8577
Active, not recruiting
Ehime, Japan, 791-0280
Recruiting
Fukuoka, Japan, 812-8582
Active, not recruiting
Gifu, Japan, 501-1194
Recruiting
Hiroshima, Japan, 730-8518
Recruiting
Hyogo, Japan, 650-0047
Active, not recruiting
Kanagawa, Japan, 241-8515
Recruiting
Kanagawa, Japan, 216-8511
Recruiting
Osaka, Japan, 558-8558
Active, not recruiting
Osaka, Japan, 537-8511
Active, not recruiting
Saitama, Japan, 362-0806
Active, not recruiting
Tokyo, Japan, 104-0045
Recruiting
Toyama, Japan, 930-0194
Korea, Republic of
Recruiting
Daegu, Korea, Republic of, 702-911
Recruiting
Seoul, Korea, Republic of, 120-752
Recruiting
Seoul, Korea, Republic of, 110-744
Recruiting
Seoul, Korea, Republic of, 135-710
Recruiting
Seoul, Korea, Republic of, 137-701
Recruiting
Seoul, Korea, Republic of, 138-736
Macedonia, The Former Yugoslav Republic of
Recruiting
Bitola, Macedonia, The Former Yugoslav Republic of, 7000
Active, not recruiting
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Malaysia
Completed
Kelantan, Malaysia, 16150
Recruiting
Kuala Lumpur, Malaysia, 59100
Completed
Kuala Lumpur, Malaysia, 50586
Recruiting
Sabah, Malaysia, 88996
Mexico
Recruiting
Mexico City, Mexico, 06760
Recruiting
Mexico City, Mexico, 14000
Active, not recruiting
Oaxaca, Mexico, 68000
Netherlands
Active, not recruiting
Amsterdam, Netherlands, 1105 AZ
Panama
Recruiting
Panama, Panama
Peru
Recruiting
Arequipa, Peru, 04001
Recruiting
Callao, Peru, 02
Not yet recruiting
Jesus Maria, Peru, Lima 11
Recruiting
Lima, Peru, Lima 41
Recruiting
Miraflores, Peru, Lima 18
Poland
Active, not recruiting
Bialystok, Poland, 15-027
Completed
Brzozów, Poland, 36-200
Recruiting
Bydgoszcz, Poland, 85-796
Recruiting
Krakow, Poland, 31-531
Active, not recruiting
Opole, Poland, 45-060
Recruiting
Poznan, Poland, 61-485
Recruiting
Rybnik, Poland, 44-200
Recruiting
Warszawa, Poland, 02-781
Terminated
Wroclaw, Poland, 53-439
Romania
Recruiting
Bucharest, Romania, 022328
Active, not recruiting
Cluj-Napoca, Romania, 400015
Recruiting
Cluj-Napoca, Romania, 400015
Recruiting
Craiova, Romania, 200385
Recruiting
Iasi, Romania, 700106
Russian Federation
Recruiting
Kazan, Russian Federation, 420029
Recruiting
Omsk, Russian Federation, 644013
Completed
Rostov-on-Don, Russian Federation, 344037
Recruiting
Ryazan, Russian Federation, 390011
Recruiting
Samara, Russian Federation, 443031
Spain
Recruiting
Elche, Alicante, Spain, 03203
Active, not recruiting
Barcelona, Spain, 08041
Recruiting
Barcelona, Spain, 08035
Recruiting
Barcelona, Spain, 08916
Recruiting
Barcelona, Spain, 08003
Active, not recruiting
Barcelona, Spain, 08907
Recruiting
Cordoba, Spain, 14004
Recruiting
Madrid, Spain, 28034
Recruiting
Madrid, Spain, 28041
Switzerland
Recruiting
Lausanne, Switzerland, 1011
Active, not recruiting
Luzern, Switzerland, 6004
Terminated
Zürich, Switzerland, 8063
Taiwan
Recruiting
Taichung, Taiwan, 407
Recruiting
Tainan, Taiwan, 00704
Recruiting
Taipei, Taiwan, 00112
Recruiting
Taipei, Taiwan, 100
Recruiting
Taoyuan, Taiwan, 333
Thailand
Recruiting
Bangkok, Thailand, 10400
Recruiting
Bangkok, Thailand, 10700
Recruiting
Khonkaen, Thailand, 40000
Recruiting
Patumwan, Thailand, 10330
Recruiting
Songkhla, Thailand, 90110
Turkey
Completed
Ankara, Turkey, 06590
Recruiting
Antalya, Turkey, 07070
Recruiting
Edirne, Turkey, 22770
Active, not recruiting
Erzurum, Turkey, 25240
Recruiting
Istanbul, Turkey, 34300
Completed
Konya, Turkey, 42080
Recruiting
Malatya, Turkey, 44280
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01774786     History of Changes
Other Study ID Numbers: BO25114
Study First Received: January 21, 2013
Last Updated: October 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases
Capecitabine
Fluorouracil
Pertuzumab
Trastuzumab
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014