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NCT02141295 · ClinicalTrials.gov registry record · Phase 2
A Study Comparing the Efficacy and Safety of Vanucizumab and FOLFOX With Bevacizumab and FOLFOX in Participants With Untreated Metastatic Colorectal Cancer
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 2
- Development phase
- 197
- Enrollment target
NCT02141295 is a Phase 2 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 197 participants.
The verdict
NCT02141295, a Phase 2 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 197 participants
- Enrollment target
Study Summary
This is a Phase 2 multicenter, randomized, parallel arms, double-blind study of vanucizumab to evaluate the efficacy and safety of vanucizumab in combination with oxaliplatin, folinic acid, and 5-fluorouracil (5-FU) (mFOLFOX-6) versus bevacizumab (Avastin) + mFOLFOX-6 in participants with previously untreated metastatic colorectal cancer (mCRC). The study consists of 2 parts: a safety run-in open-label, single-arm part (Part 1) and a randomized, parallel-arms, double-blind part (Part 2). During Part 1 at least 6 eligible participants will receive 2000 milligrams (mg) vanucizumab every 2 weeks + mFOLFOX-6 in order to confirm the dose and schedule that will be used in Part 2. In Part 2, all eligible participants will be randomized in a ratio of 1:1 to receive either mFOLFOX-6 + vanucizumab or mFOLFOX-6 + bevacizumab. Study treatment (induction and maintenance) will be given on Day 1 of each 14-day cycle. Induction therapy will consist of up to 8 cycles of mFOLFOX-6 plus either bevacizumab or vanucizumab. Maintenance therapy will consist of 5-fluorouracil and folinic acid plus either vanucizumab or bevacizumab for up to 24 months or until disease progression, unacceptable toxicity, Investigator decision or consent withdrawal, whichever occurs first.
Interventions
- DRUG Bevacizumab
- DRUG Oxaliplatin
- DRUG 5-FU
- DRUG Folinic acid
- DRUG Vanucizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2014-06-30 |
| Est. Completion | 2017-02-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02141295
The ClinicalTrials.gov registry entry for NCT02141295 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 197 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 Bevacizumab is the first listed.
NCT02141295 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02141295 about?
NCT02141295 is a clinical study titled "A Study Comparing the Efficacy and Safety of Vanucizumab and FOLFOX With Bevacizumab and FOLFOX in Participants With Untreated Metastatic Colorectal Cancer". This is a Phase 2 multicenter, randomized, parallel arms, double-blind study of vanucizumab to evaluate the efficacy and safety of vanucizumab in combination with oxaliplatin, folinic acid, and 5-fluorouracil (5-FU) (mFOLFOX-6) versus bevacizumab (Avastin) + mFOLFOX-6 in participants with previously...
What is the current status of trial NCT02141295?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 197 participants. The study started on 2014-06-30. Estimated completion is 2017-02-01.
What interventions are being tested in trial NCT02141295?
The interventions under investigation include: Bevacizumab (DRUG), Oxaliplatin (DRUG), 5-FU (DRUG), Folinic acid (DRUG), Vanucizumab (DRUG).
Who is sponsoring clinical trial NCT02141295?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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