A Study of Onartuzumab (MetMAb) in Combination With mFOLFOX6 in Patients With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2) Negative Gastroesophageal Cancer
Public ClinicalTrials.gov record NCT01590719. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Phase II, 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 Gastroesophageal Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with mFOLFOX6 in patients with metastatic HER2-negative adenocarcinoma of the stomach or gastroesophageal junction. Patients will be randomized in a 1:1 ratio 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 discontinue treatment.
Study identification
- NCT ID
- NCT01590719
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 123 participants
Conditions and interventions
Conditions
Interventions
- Placebo Drug
- Onartuzumab (MetMAb) Drug
- Oxaliplatin Drug
- Folinic acid Drug
- Levofolinic acid Drug
- 5-Fluorouracil Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2012 (Type not available)
- Primary completion
- Oct 2014 (Actual)
- Completion
- Oct 2014 (Actual)
- Last update posted
- Aug 9, 2016
2012 – 2014
United States locations
- U.S. sites
- 18
- U.S. states
- 10
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Denver | Colorado | 80218 | — |
| Not listed | New Haven | Connecticut | 06520 | — |
| Not listed | Fort Myers | Florida | 33908 | — |
| Not listed | St. Petersburg | Florida | 33705 | — |
| Not listed | Chicago | Illinois | 60637 | — |
| Not listed | Niles | Illinois | 60714 | — |
| Not listed | Albany | New York | 12206 | — |
| Not listed | New York | New York | 10065 | — |
| Not listed | Cincinnati | Ohio | 45219 | — |
| Not listed | Nashville | Tennessee | 37203 | — |
| Not listed | Austin | Texas | 78731 | — |
| Not listed | Bedford | Texas | 76022 | — |
| Not listed | Garland | Texas | 77060 | — |
| Not listed | The Woodlands | Texas | 77380 | — |
| Not listed | Tyler | Texas | 75702 | — |
| Not listed | Fairfax | Virginia | 22031 | — |
| Not listed | Richmond | Virginia | 23226 | — |
| Not listed | Vancouver | Washington | 98684 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 18 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01590719, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 9, 2016 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01590719 live on ClinicalTrials.gov.