Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00779311 · ClinicalTrials.gov registry record · Phase 1
A Phase I Trial Evaluating mFOLFOX6 and Avastin With Nexavar as First-Line Treatment for Metastatic Colorectal Cancer
A Phase 1 study, sponsored by Accelerated Community Oncology Research Network.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT00779311: Clinical Trial Phase 1 study, sponsored by Accelerated Community Oncology Research Network.
NCT00779311 is a Phase 1 study that was terminated before completion, run by Accelerated Community Oncology Research Network. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00779311, a Phase 1 study, was terminated before completion, sponsored by Accelerated Community Oncology Research Network.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This research study is being performed at approximately 3 sites associated with Accelerated Community Oncology Research Network, Inc. (ACORN). Approximately 45 subjects will take part in this study. In this study, everyone will receive the same dose of mFOLFOX6 and Avastin. There will be five groups of subjects. Each group of subjects will receive a higher dose of Nexavar than the previous group. This will continue until a subject group has a major side effects from the dose they are given. This is so that the sponsor can determine the highest dose of Nexavar that can be used with mFOLFOX6 and AVastin (this is called the maximum tolerated dose or MTD).
Primary Outcome
The MTD of sorafenib was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose depends on the frequency of dose limiting toxicities (DLT) at each dosage. If 0 out of 3 patients experience a DLT at a given dosage level, 3 patients will be enrolled at the next dosage level. If greater than or equal to 2 patients experience a DLT at a given dosage level, dosage escalation will be stopped. If 1 out of 3 patients experience
Interventions
- DRUG sorafenib
- DRUG bevacizumab
- DRUG mFOLFOX6 regimen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2008-10 |
| Est. Completion | 2011-03 |
| Phase | Phase 1 |
Why NCT00779311 stopped before completion
NCT00779311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which sorafenib is the first listed.
NCT00779311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00779311 about?
NCT00779311 is a clinical study titled "A Phase I Trial Evaluating mFOLFOX6 and Avastin With Nexavar as First-Line Treatment for Metastatic Colorectal Cancer". This research study is being performed at approximately 3 sites associated with Accelerated Community Oncology Research Network, Inc. (ACORN). Approximately 45 subjects will take part in this study. In this study, everyone will receive the same dose of mFOLFOX6 and Avastin. There will be five group...
What is the current status of trial NCT00779311?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2008-10. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00779311?
The interventions under investigation include: sorafenib (DRUG), bevacizumab (DRUG), mFOLFOX6 regimen (DRUG).
Who is sponsoring clinical trial NCT00779311?
This trial is sponsored by Accelerated Community Oncology Research Network, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00779311's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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 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