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NCT01326000 · ClinicalTrials.gov registry record · Phase 2
A Study of RO5083945 in Combination With FOLFIRI Versus FOLFIRI Plus Cetuximab or FOLFIRI Alone as Second Line Treatment in Patients With Metastatic Colorectal Cancer
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 169
- Enrollment target
NCT01326000 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 169 participants.
The verdict
NCT01326000, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 169 participants
- Enrollment target
Study Summary
This randomized, multicenter, open label study will evaluate the safety and efficacy of RO5083945 in combination with FOLFIRI as compared to FOLFIRI plus cetuximab or FOLFIRI alone as second line treatment in patients with metastatic colorectal cancer. Patients will be randomized to receive RO5083945 (1400 mg intravenously on Day 1 and Day 8 and every 2 weeks thereafter) plus FOLFIRI standard iv chemotherapy or FOLFIRI plus cetuximab (400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week) or FOLFIRI alone. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Interventions
- DRUG cetuximab
- DRUG FOLFIRI
- DRUG RO5083945
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2011-04 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01326000
The ClinicalTrials.gov registry entry for NCT01326000 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 169 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 3 interventions - of which cetuximab is the first listed.
NCT01326000 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01326000 about?
NCT01326000 is a clinical study titled "A Study of RO5083945 in Combination With FOLFIRI Versus FOLFIRI Plus Cetuximab or FOLFIRI Alone as Second Line Treatment in Patients With Metastatic Colorectal Cancer". This randomized, multicenter, open label study will evaluate the safety and efficacy of RO5083945 in combination with FOLFIRI as compared to FOLFIRI plus cetuximab or FOLFIRI alone as second line treatment in patients with metastatic colorectal cancer. Patients will be randomized to receive RO508394...
What is the current status of trial NCT01326000?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 169 participants. The study started on 2011-04. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01326000?
The interventions under investigation include: cetuximab (DRUG), FOLFIRI (DRUG), RO5083945 (DRUG).
Who is sponsoring clinical trial NCT01326000?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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