A Study of Onartuzumab (MetMAb) in Combination With mFOLFOX6 in Patients With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2) Negative Gastroesophageal Cancer
NCT ID: NCT01590719
Last Updated: 2016-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
123 participants
INTERVENTIONAL
2012-07-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Onartuzumab (MetMAb) with mFOLFOX6
Onartuzumab (MetMAb) in combination with mFOLFOX6 (modified 5-fluorouracil, folinic acid \[leucovorin\], and oxaliplatin)
Onartuzumab (MetMAb)
Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Oxaliplatin
Oxaliplatin 85 mg/m2 IV every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Folinic acid
Folinic acid 400 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Levofolinic acid
If folinic acid is unavailable: levofolinic acid 200 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
5-Fluorouracil
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 with mFOLFOX6
Placebo in combination with mFOLFOX6 (modified 5-fluorouracil, folinic acid \[leucovorin\], and oxaliplatin)
Placebo
Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Oxaliplatin
Oxaliplatin 85 mg/m2 IV every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Folinic acid
Folinic acid 400 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Levofolinic acid
If folinic acid is unavailable: levofolinic acid 200 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
5-Fluorouracil
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
Interventions
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Placebo
Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Onartuzumab (MetMAb)
Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Oxaliplatin
Oxaliplatin 85 mg/m2 IV every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Folinic acid
Folinic acid 400 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Levofolinic acid
If folinic acid is unavailable: levofolinic acid 200 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
5-Fluorouracil
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 Criteria
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Inclusion Criteria
* Adenocarcinoma of the stomach or gastroesophageal junction with inoperable, metastatic disease, not amenable for curative therapy
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Life expectancy \>3 months
* Presence of tissue sample for immunohistochemistry assay of Met receptor and HER2 status (if unknown)
* Radiographic evidence of disease; 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
* 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 hepatocyte growth factor (HGF) or Met pathway
* History of other 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
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Denver, Colorado, United States
New Haven, Connecticut, United States
Fort Myers, Florida, United States
St. Petersburg, Florida, United States
Chicago, Illinois, United States
Niles, Illinois, United States
Albany, New York, United States
New York, New York, United States
Cincinnati, Ohio, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Bedford, Texas, United States
Garland, Texas, United States
The Woodlands, Texas, United States
Tyler, Texas, United States
Fairfax, Virginia, United States
Richmond, Virginia, United States
Vancouver, Washington, United States
Sydney, New South Wales, Australia
Herston, Queensland, Australia
Woodville South, South Australia, Australia
East Bentleigh, Victoria, Australia
Heidelberg, Victoria, Australia
Nedlands, Western Australia, Australia
Singapore, , Singapore
Singapore, , Singapore
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Tainan City, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taoyuan, , Taiwan
Bangkok, , Thailand
Bangkok, , Thailand
Bangkok, , Thailand
Countries
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References
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Shah MA, Cho JY, Tan IB, Tebbutt NC, Yen CJ, Kang A, Shames DS, Bu L, Kang YK. A Randomized Phase II Study of FOLFOX With or Without the MET Inhibitor Onartuzumab in Advanced Adenocarcinoma of the Stomach and Gastroesophageal Junction. Oncologist. 2016 Sep;21(9):1085-90. doi: 10.1634/theoncologist.2016-0038. Epub 2016 Jul 8.
Other Identifiers
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2012-000858-57
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
YO28252
Identifier Type: -
Identifier Source: org_study_id
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