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NCT01590719 · ClinicalTrials.gov registry record · Phase 2
A Study of Onartuzumab (MetMAb) in Combination With mFOLFOX6 in Patients With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2) Negative Gastroesophageal Cancer
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 123
- Enrollment target
NCT01590719: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT01590719 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 123 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01590719, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 123 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo
- DRUG Oxaliplatin
- DRUG Folinic acid
- DRUG Onartuzumab (MetMAb)
- DRUG Levofolinic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2012-07 |
| Est. Completion | 2014-10 |
| Phase | Phase 2 |
What the finished NCT01590719 record still lists
NCT01590719 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01590719 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01590719 about?
NCT01590719 is a clinical study titled "A Study of Onartuzumab (MetMAb) in Combination With mFOLFOX6 in Patients With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2) Negative Gastroesophageal Cancer". 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 r...
What is the current status of trial NCT01590719?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 123 participants. The study started on 2012-07. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01590719?
The interventions under investigation include: Placebo (DRUG), Oxaliplatin (DRUG), Folinic acid (DRUG), Onartuzumab (MetMAb) (DRUG), Levofolinic acid (DRUG).
Who is sponsoring clinical trial NCT01590719?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01590719's enrollment target sits among peer trials
123 564th of 2000 higher than 1,436 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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