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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 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 123 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01590719
The ClinicalTrials.gov registry entry for NCT01590719 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01590719 reports 0 study locations.
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.
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