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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01662869
First received: August 8, 2012
Last updated: September 22, 2014
Last verified: September 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 ]

Enrollment: 564
Study Start Date: November 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 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

  Hide Study Locations
Locations
United States, California
Los Angeles, California, United States, 90095
United States, Colorado
Denver, Colorado, United States, 80218
United States, Florida
Fort Myers, Florida, United States, 33908
St Petersburg, Florida, United States, 33705
United States, Illinois
Chicago, Illinois, United States, 60637
United States, New York
Albany, New York, United States, 12206
New York, New York, United States, 10065
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati, Ohio, United States, 45219
United States, Rhode Island
Providence, Rhode Island, United States, 02903
Providence, Rhode Island, United States, 02906
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Austin, Texas, United States, 78731
Tyler, Texas, United States, 75702
United States, Washington
Vancouver, Washington, United States, 98684
Australia, New South Wales
Port Macquarie, New South Wales, Australia, 2444
Sydney, New South Wales, Australia, 2139
Australia, Queensland
Herston, Queensland, Australia, 4029
Australia, Victoria
Box Hill, Victoria, Australia, 3128
East Bentleigh, Victoria, Australia, VIC 3165
Australia, Western Australia
Nedlands, Western Australia, Australia, 6009
Belgium
Brugge, Belgium, 8000
Leuven, Belgium, 3000
Sint-Niklaas, Belgium, 9100
Canada, Ontario
Hamilton, Ontario, Canada, L8L 2X2
Toronto, Ontario, Canada, M4N 3M5
Toronto, Ontario, Canada, M5B 1N9
Toronto, Ontario, Canada, M5G 2M9
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Montreal, Quebec, Canada, H3T 1E2
Czech Republic
Brno, Czech Republic, 656 53
Olomouc, Czech Republic, 775 20
France
Angers, France, 49933
Avignon, France, 84918
Besancon, France, 25030
Brest, France, 29200
Clichy, France, 92118
Marseille, France, 13273
Paris, France, 75571
Paris, France, 75674
Paris, France, 75475
St Herblain, France, 44805
Toulouse, France, 31059
Germany
Bochum, Germany, 44892
Essen, Germany, 45122
Hamburg, Germany, 22767
Leipzig, Germany, 04103
Ludwigsburg, Germany, 71640
Mannheim, Germany, 68167
Marburg, Germany, 35043
München, Germany, 81675
Guatemala
Guatemala, Guatemala, 01009
Hong Kong
Hong Kong, Hong Kong, 852
Hong Kong, Hong Kong
Israel
Jerusalem, Israel, 91120-01
Ramat Gan, Israel, 52620-00
Tel Aviv, Israel, 64239-06
Italy
Catanzaro, Calabria, Italy, 88100
Udine, Friuli-Venezia Giulia, Italy, 33100
Roma, Lazio, Italy, 00168
Milano, Lombardia, Italy, 20133
Milano, Lombardia, Italy, 20132
Torino, Piemonte, Italy, 10126
Firenze, Toscana, Italy, 50139
Prato, Toscana, Italy, 59100
Korea, Republic of
Seoul, Korea, Republic of, 136-705
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 120-749
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 137-701
Seoul, Korea, Republic of, 135-720
Malaysia
Kuala Lumpur, Malaysia, 59100
Sabah, Malaysia, 88996
Mexico
Aguascalientes, Mexico, 20230
Monterrey, Mexico, 64020
Oaxaca, Mexico, 68000
Panama
Panama, Panama, 0834-02723
Poland
Bydgoszcz, Poland, 85-796
Gdansk, Poland, 80-952
Krakow, Poland, 30-501
Lublin, Poland, 20-081
Rybnik, Poland, 44-200
Warszawa, Poland, 02-781
Russian Federation
Ivanovo, Russian Federation, 153040
Omsk, Russian Federation, 644013
Ryazan, Russian Federation, 390011
Samara, Russian Federation, 443031
Tula, Russian Federation, 300053
Singapore
Singapore, Singapore, 169610
Spain
Elche, Alicante, Spain, 03203
Santander, Cantabria, Spain, 39008
Barcelona, Spain, 08036
Barcelona, Spain, 08003
Barcelona, Spain, 08035
Madrid, Spain, 28046
Madrid, Spain, 28007
Zaragoza, Spain, 50009
Switzerland
Luzern, Switzerland, 6004
Zürich, Switzerland, 8063
Taiwan
Changhua, Taiwan, 500
Kaohisung, Taiwan
Taichung, Taiwan, 404
Taichung, Taiwan, 407
Taipei, Taiwan, 100
Taipei, Taiwan, 00112
Taipei, Taiwan, 112
Thailand
Bangkok, Thailand, 10400
Bangkok, Thailand, 10700
Chiang Rai, Thailand, 57000
Hat Yai, Thailand, 90110
Lopburi, Thailand, 15000
Turkey
Antalya, Turkey, 07070
Edirne, Turkey, 22770
Erzurum, Turkey, 25240
Malatya, Turkey, 44280
S?hhiye, ANKARA, Turkey, 06100
Samsun, Turkey, 55139
United Kingdom
Bristol, United Kingdom, BS2 8ED
Cardiff, United Kingdom, CF14 2TL
London, United Kingdom, SW3 6JJ
Manchester, United Kingdom, M2O 4BX
Southampton, United Kingdom, SO16 6YD
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: September 22, 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

ClinicalTrials.gov processed this record on September 30, 2014