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NCT01662869 · ClinicalTrials.gov registry record · Phase 3
A Study of Onartuzumab in Combination With mFOLFOX6 in Participants With Metastatic HER2-Negative and MET-Positive Gastroesophageal Cancer
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 564
- Enrollment target
NCT01662869 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 564 participants.
The verdict
NCT01662869, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 564 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 5-fluorouracil, folinic Acid, and oxaliplatin (mFOLFOX6) in participants with metastatic human epidermal growth receptor (HER) 2-negative and MET-positive adenocarcinoma of the stomach or gastroesophageal junction. Participants will be randomized in a 1:1 ratio to receive either onartuzumab or placebo in combination with mFOLFOX6. Participants may continue to receive onartuzumab or placebo until disease progression, unacceptable toxicity, participant or physician decision to discontinue treatment.
Interventions
- DRUG Placebo
- DRUG Oxaliplatin
- DRUG Folinic acid
- DRUG 5-Fluoruracil
- DRUG Onartuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 564 participants |
| Start Date | 2012-11 |
| Est. Completion | 2015-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01662869
The ClinicalTrials.gov registry entry for NCT01662869 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 564 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.
NCT01662869 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01662869 about?
NCT01662869 is a clinical study titled "A Study of Onartuzumab in Combination With mFOLFOX6 in Participants With Metastatic HER2-Negative and MET-Positive Gastroesophageal Cancer". This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with 5-fluorouracil, folinic Acid, and oxaliplatin (mFOLFOX6) in participants with metastatic human epidermal growth receptor (HER) 2-negative and MET-pos...
What is the current status of trial NCT01662869?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 564 participants. The study started on 2012-11. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01662869?
The interventions under investigation include: Placebo (DRUG), Oxaliplatin (DRUG), Folinic acid (DRUG), 5-Fluoruracil (DRUG), Onartuzumab (DRUG).
Who is sponsoring clinical trial NCT01662869?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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