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NCT01133990 · ClinicalTrials.gov registry record · Phase 1
FOLFIRI Alone Versus FOLFIRI Plus Bevacizumab Versus FOLFIRI Plus E7820 as Second-Line Therapy in Patients With Locally Advanced or Metastatic Colorectal Cancer
A Phase 1 study, sponsored by Eisai.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT01133990: Clinical Trial Phase 1 study, sponsored by Eisai.
NCT01133990 is a Phase 1 study that was terminated before completion, run by Eisai. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01133990, a Phase 1 study, was terminated before completion, sponsored by Eisai.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
The purpose of the Phase Ib portion is to find out the highest dose of study drug that can safely be given when tested in a small group of subjects. The purpose of the Phase II portion is to find out how safe the study drug is when taken at the highest dose in a larger group of subjects.
Primary Outcome
Dose-limiting toxicities were defined as clinically significant adverse events (AEs) occurring less than or equal to (\<=) 28 days after commencing study treatment and considered by the investigator to be possibly or probably related to study treatment. Toxicity was evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v.4.0).
Interventions
- DRUG Bevacizumab
- DRUG FOLFIRI
- DRUG E7820
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2010-03-04 |
| Est. Completion | 2011-02-18 |
| Phase | Phase 1 |
Why NCT01133990 stopped before completion
NCT01133990 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Bevacizumab is the first listed.
NCT01133990 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01133990 about?
NCT01133990 is a clinical study titled "FOLFIRI Alone Versus FOLFIRI Plus Bevacizumab Versus FOLFIRI Plus E7820 as Second-Line Therapy in Patients With Locally Advanced or Metastatic Colorectal Cancer". The purpose of the Phase Ib portion is to find out the highest dose of study drug that can safely be given when tested in a small group of subjects. The purpose of the Phase II portion is to find out how safe the study drug is when taken at the highest dose in a larger group of subjects.
What is the current status of trial NCT01133990?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2010-03-04. Estimated completion is 2011-02-18.
What interventions are being tested in trial NCT01133990?
The interventions under investigation include: Bevacizumab (DRUG), FOLFIRI (DRUG), E7820 (DRUG).
Who is sponsoring clinical trial NCT01133990?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01133990's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 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
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