Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT01326000 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 169 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01326000 record still lists
NCT01326000 is an interventional study that assigns participants to a tested intervention. The registered 169 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% higher).
The record links to 0 conditions, and to 3 interventions - of which cetuximab is the first listed.
NCT01326000 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01326000's enrollment target sits among peer trials
169 403rd of 2000 higher than 1,598 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06191484 · 169 participants · NA
Risk and Resilience to Suicide Following Late-Life Spousal Bereavement
- NCT02016430 · 170 participants · NA
Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)
- NCT02621021 · 170 participants · Phase 2
A Phase 2 Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab
- NCT04094701 · 170 participants · NA
Hip Arthroscopy Postoperative Opioid Demands
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia