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NCT01765582 · ClinicalTrials.gov registry record · Phase 2
Sequential and Concurrent FOLFOXIRI/Bevacizumab Regimens Versus FOLFOX/Bevacizumab in First-Line Metastatic Colorectal Cancer
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 2
- Development phase
- 280
- Enrollment target
NCT01765582 is a Phase 2 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 280 participants.
The verdict
NCT01765582, a Phase 2 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 280 participants
- Enrollment target
Study Summary
This randomized, open-label, multicenter study will evaluate the efficacy and safety of folinic acid (leucovorin), 5-fluorouracil (5-FU), oxaliplatin, and irinotecan (FOLFOXIRI) / bevacizumab regimens (concurrent and sequential) versus folinic acid (leucovorin), 5-fluorouracil, and oxaliplatin (FOLFOX) / bevacizumab in first-line in participants with metastatic colorectal cancer. Participants will be randomized to receive bevacizumab 5 milligrams per kilogram (mg/kg) intravenously every 2 weeks with either concurrent or sequential FOLFOXIRI or with FOLFOX for 4 to 6 months of induction therapy, followed by maintenance therapy with bevacizumab plus either leucovorin/5-fluorouracil or capecitabine until disease progression occurs. After disease progression, participants will receive treatment with a fluoropyrimidine-based chemotherapy plus bevacizumab.
Interventions
- DRUG 5-fluorouracil
- DRUG bevacizumab
- DRUG capecitabine
- DRUG folinic acid
- DRUG irinotecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2013-01-23 |
| Est. Completion | 2016-03-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01765582
The ClinicalTrials.gov registry entry for NCT01765582 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 280 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 5-fluorouracil is the first listed.
NCT01765582 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01765582 about?
NCT01765582 is a clinical study titled "Sequential and Concurrent FOLFOXIRI/Bevacizumab Regimens Versus FOLFOX/Bevacizumab in First-Line Metastatic Colorectal Cancer". This randomized, open-label, multicenter study will evaluate the efficacy and safety of folinic acid (leucovorin), 5-fluorouracil (5-FU), oxaliplatin, and irinotecan (FOLFOXIRI) / bevacizumab regimens (concurrent and sequential) versus folinic acid (leucovorin), 5-fluorouracil, and oxaliplatin (FOLF...
What is the current status of trial NCT01765582?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 280 participants. The study started on 2013-01-23. Estimated completion is 2016-03-14.
What interventions are being tested in trial NCT01765582?
The interventions under investigation include: 5-fluorouracil (DRUG), bevacizumab (DRUG), capecitabine (DRUG), folinic acid (DRUG), irinotecan (DRUG).
Who is sponsoring clinical trial NCT01765582?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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