A Study of Onartuzumab (MetMAb) in Combination With mFOLFOX6 in Patients With Metastatic HER2-Negative And Met-Positive Gastroesophageal Cancer (MetGastric)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Hoffmann-La Roche
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01662869
First received: August 8, 2012
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

This randomized, multicenter, double-blind, placebo-controlled study will evalua te the efficacy and safety of onartuzumab (MetMAb) in combination with mFOLFOX6 in patients with metastatic HER2-negative and Met-positive adenocarcinoma of the stomach or gastroesophageal junction. Patients will be randomized in a 1:1 rati

o to receive either onartuzumab (MetMAb) or placebo in combination with mFOLFOX6 Patients may continue to receive onartuzumab (MetMAb) or placebo until disease progression, unacceptable toxicity, patient or physician decision to discontinu e treatment.


Condition Intervention Phase
Gastric Cancer
Drug: Onartuzumab
Drug: Placebo
Drug: mFOLFOX6
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 Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating The Efficacy And Safety Of Onartuzumab (MetMAb) In Combination With 5-Fluorouracil, Folinic Acid, And Oxaliplatin (mFOLFOX6) In Patients With Metastatic Her2-Negative, Met-Positive Gastroesophageal Cancer (MetGastric)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival (OS) in the Met IHC 2+/3+ patient subgroup [ Time Frame: Approximately 38 months ] [ Designated as safety issue: No ]
  • Overall survival in the intent-to-treat population [ Time Frame: Approximately 38 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Approximately 38 months ] [ Designated as safety issue: No ]
  • Overall response rate (ORR) [ Time Frame: Approximately 38 months ] [ Designated as safety issue: No ]
  • Safety: incidence of adverse events [ Time Frame: Approximately 38 months ] [ Designated as safety issue: No ]
  • European Organization for Research and Treatment Cancer - Quality of life questionnaire [ Time Frame: Approximately 38 months ] [ Designated as safety issue: No ]
  • European Organization for Research and Treatment Cancer - Gastric cancer-specific quality of life questionnaire [ Time Frame: Approximately 38 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: November 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Onartuzumab Arm Drug: Onartuzumab
Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Drug: mFOLFOX6
Oxaliplatin 85 mg/m2 IV, folinic acid 400 mg/m2 (or as deemed appropriate per investigator),or levofolinic acid 200 mg/m2 (or as deemed appropriate per investigator), 5-fluorouracil 400 mg/m2 IV followed by 2400 mg/m2 IV infusion every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Placebo Comparator: Placebo Arm Drug: Placebo
Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Drug: mFOLFOX6
Oxaliplatin 85 mg/m2 IV, folinic acid 400 mg/m2 (or as deemed appropriate per investigator),or levofolinic acid 200 mg/m2 (or as deemed appropriate per investigator), 5-fluorouracil 400 mg/m2 IV followed by 2400 mg/m2 IV infusion every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment

  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 and older
  • Adenocarcinoma of the stomach or gastroesophageal junction with inoperable, metastatic disease, not amenable for curative therapy
  • ECOG performance status 0 or 1
  • Life expectancy >3 months
  • Presence of tissue sample for immunohistochemistry assay of Met receptor and HER2 status
  • Tumor (primary or metastatic lesion) defined as Met-positive by immunohistochemistry
  • Measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1); Patients with peritoneal disease would generally be regarded as having evaluable disease and allowed to enter the trial.
  • For women who are not postmenopausal or surgically sterile; agreement to use an adequate method of contraception (e.g., hormonal implant) during the treatment period and for at least 90 days after the last dose of onartuzumab/placebo and 6 months after the last dose of oxaliplatin
  • For men: agreement to use a barrier method of contraception during the treatment period and for 90 days after the last dose of onartuzumab/placebo and 6 months after the last dose of oxaliplatin
  • Adequate laboratory values

Exclusion Criteria:

  • HER2-positive tumor (primary tumor or metastasis)
  • Previous chemotherapy for locally advanced or metastatic gastric carcinoma (adjuvant or neoadjuvant chemotherapy must be completed at least 6 months prior to randomization)
  • Prior treatment with investigational drugs that target the HGF or Met pathway
  • History of another malignancy within the previous 5 years, except for appropriately treated and presumed cured carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, and localized prostate cancer
  • Receipt of an investigational drug within 28 days prior to study start
  • Clinically significant gastrointestinal abnormalities, except from gastric cancer (e.g., Crohn's disease)
  • Significant history of cardiac disease
  • Significant vascular disease
  • Infection with human immunodeficiency virus, hepatitis B, or hepatitis C
  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: NCT01662869

Contacts
Contact: Reference Study ID Number: YO28322 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
United States, California
Completed
Los Angeles, California, United States, 90095
United States, Colorado
Active, not recruiting
Denver, Colorado, United States, 80218
United States, Florida
Recruiting
Fort Myers, Florida, United States, 33908
Completed
St Petersburg, Florida, United States, 33705
United States, Illinois
Active, not recruiting
Chicago, Illinois, United States, 60637
United States, New York
Completed
Albany, New York, United States, 12206
Active, not recruiting
New York, New York, United States, 10065
United States, North Carolina
Active, not recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Active, not recruiting
Cincinnati, Ohio, United States, 45219
United States, Rhode Island
Completed
Providence, Rhode Island, United States, 02903
Completed
Providence, Rhode Island, United States, 02906
United States, Tennessee
Active, not recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Active, not recruiting
Austin, Texas, United States, 78731
Completed
Tyler, Texas, United States, 75702
United States, Washington
Completed
Vancouver, Washington, United States, 98684
Australia, New South Wales
Active, not recruiting
Port Macquarie, New South Wales, Australia, 2444
Active, not recruiting
Sydney, New South Wales, Australia, 2139
Australia, Queensland
Active, not recruiting
Herston, Queensland, Australia, 4029
Australia, Victoria
Completed
Box Hill, Victoria, Australia, 3128
Active, not recruiting
East Bentleigh, Victoria, Australia, VIC 3165
Australia, Western Australia
Active, not recruiting
Nedlands, Western Australia, Australia, 6009
Belgium
Active, not recruiting
Brugge, Belgium, 8000
Active, not recruiting
Leuven, Belgium, 3000
Terminated
Sint-Niklaas, Belgium, 9100
Canada, Ontario
Active, not recruiting
Hamilton, Ontario, Canada, L8L 2X2
Active, not recruiting
Toronto, Ontario, Canada, M4N 3M5
Active, not recruiting
Toronto, Ontario, Canada, M5B 1N9
Active, not recruiting
Toronto, Ontario, Canada, M5G 2M9
Active, not recruiting
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Active, not recruiting
Montreal, Quebec, Canada, H3T 1E2
Czech Republic
Recruiting
Brno, Czech Republic, 656 53
Recruiting
Olomouc, Czech Republic, 775 20
France
Active, not recruiting
Angers, France, 49933
Active, not recruiting
Avignon, France, 84918
Active, not recruiting
Besancon, France, 25030
Active, not recruiting
Brest, France, 29200
Completed
Clichy, France, 92118
Active, not recruiting
Marseille, France, 13273
Active, not recruiting
Paris, France, 75571
Active, not recruiting
Paris, France, 75674
Active, not recruiting
Paris, France, 75475
Active, not recruiting
St Herblain, France, 44805
Active, not recruiting
Toulouse, France, 31059
Germany
Completed
Bochum, Germany, 44892
Active, not recruiting
Essen, Germany, 45122
Active, not recruiting
Hamburg, Germany, 22767
Active, not recruiting
Leipzig, Germany, 04103
Active, not recruiting
Ludwigsburg, Germany, 71640
Active, not recruiting
Mannheim, Germany, 68167
Active, not recruiting
Marburg, Germany, 35043
Active, not recruiting
München, Germany, 81675
Guatemala
Completed
Guatemala, Guatemala, 01009
Hong Kong
Active, not recruiting
Hong Kong, Hong Kong, 852
Active, not recruiting
Hong Kong, Hong Kong
Israel
Active, not recruiting
Jerusalem, Israel, 91120-01
Active, not recruiting
Ramat Gan, Israel, 52620-00
Active, not recruiting
Tel Aviv, Israel, 64239-06
Italy
Active, not recruiting
Catanzaro, Calabria, Italy, 88100
Active, not recruiting
Udine, Friuli-Venezia Giulia, Italy, 33100
Active, not recruiting
Roma, Lazio, Italy, 00168
Active, not recruiting
Milano, Lombardia, Italy, 20133
Active, not recruiting
Milano, Lombardia, Italy, 20132
Active, not recruiting
Torino, Piemonte, Italy, 10126
Active, not recruiting
Firenze, Toscana, Italy, 50139
Active, not recruiting
Prato, Toscana, Italy, 59100
Korea, Republic of
Active, not recruiting
Seoul, Korea, Republic of, 138-736
Active, not recruiting
Seoul, Korea, Republic of, 136-705
Active, not recruiting
Seoul, Korea, Republic of, 120-749
Active, not recruiting
Seoul, Korea, Republic of, 135-710
Active, not recruiting
Seoul, Korea, Republic of, 110-744
Active, not recruiting
Seoul, Korea, Republic of, 137-701
Active, not recruiting
Seoul, Korea, Republic of, 135-720
Malaysia
Active, not recruiting
Kuala Lumpur, Malaysia, 59100
Completed
Sabah, Malaysia, 88996
Mexico
Active, not recruiting
Aguascalientes, Mexico, 20230
Active, not recruiting
Monterrey, Mexico, 64020
Active, not recruiting
Oaxaca, Mexico, 68000
Panama
Active, not recruiting
Panama, Panama, 0834-02723
Poland
Active, not recruiting
Bydgoszcz, Poland, 85-796
Active, not recruiting
Gdansk, Poland, 80-952
Terminated
Krakow, Poland, 30-501
Active, not recruiting
Lublin, Poland, 20-081
Active, not recruiting
Rybnik, Poland, 44-200
Active, not recruiting
Warszawa, Poland, 02-781
Russian Federation
Active, not recruiting
Ivanovo, Russian Federation, 153040
Active, not recruiting
Omsk, Russian Federation, 644013
Active, not recruiting
Ryazan, Russian Federation, 390011
Active, not recruiting
Samara, Russian Federation, 443031
Active, not recruiting
Tula, Russian Federation, 300053
Singapore
Active, not recruiting
Singapore, Singapore, 169610
Spain
Active, not recruiting
Elche, Alicante, Spain, 03203
Completed
Santander, Cantabria, Spain, 39008
Active, not recruiting
Barcelona, Spain, 08036
Active, not recruiting
Barcelona, Spain, 08003
Active, not recruiting
Barcelona, Spain, 08035
Completed
Madrid, Spain, 28046
Active, not recruiting
Madrid, Spain, 28041
Active, not recruiting
Zaragoza, Spain, 50009
Switzerland
Active, not recruiting
Luzern, Switzerland, 6004
Completed
Zürich, Switzerland, 8063
Taiwan
Active, not recruiting
Changhua, Taiwan, 500
Active, not recruiting
Kaohisung, Taiwan
Active, not recruiting
Taichung, Taiwan, 407
Active, not recruiting
Taichung, Taiwan, 404
Active, not recruiting
Taipei, Taiwan, 100
Active, not recruiting
Taipei, Taiwan, 00112
Terminated
Taipei, Taiwan, 112
Thailand
Active, not recruiting
Bangkok, Thailand, 10400
Active, not recruiting
Bangkok, Thailand, 10700
Active, not recruiting
Chiang Rai, Thailand, 57000
Active, not recruiting
Hat Yai, Thailand, 90110
Active, not recruiting
Lopburi, Thailand, 15000
Turkey
Active, not recruiting
Antalya, Turkey, 07070
Active, not recruiting
Edirne, Turkey, 22770
Active, not recruiting
Erzurum, Turkey, 25240
Active, not recruiting
Malatya, Turkey, 44280
Active, not recruiting
S?hhiye, ANKARA, Turkey, 06100
Active, not recruiting
Samsun, Turkey, 55139
United Kingdom
Active, not recruiting
Bristol, United Kingdom, BS2 8ED
Active, not recruiting
Cardiff, United Kingdom, CF14 2TL
Active, not recruiting
London, United Kingdom, SW3 6JJ
Active, not recruiting
Manchester, United Kingdom, M2O 4BX
Completed
Southampton, United Kingdom, SO16 6YD
Completed
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Hoffmann-La Roche
Genentech
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01662869     History of Changes
Other Study ID Numbers: YO28322, 2012-001402-23
Study First Received: August 8, 2012
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Fluorouracil
Leucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 22, 2014