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NCT01347645 · ClinicalTrials.gov registry record · Phase 1
Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer
A Phase 1 study, sponsored by Eisai.
- Terminated
- Registry status
- Phase 1
- Development phase
- 82
- Enrollment target
NCT01347645: Clinical Trial Phase 1 study, sponsored by Eisai.
NCT01347645 is a Phase 1 study that was terminated before completion, run by Eisai. The registered enrollment target is 82 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01347645, a Phase 1 study, was terminated before completion, sponsored by Eisai.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 82 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
MTD: maximum dose that was determined to be safe and tolerable for Phase 2.If two dose limiting toxicities (DLTs) occurred at any dose level,MTD: preceding dose/intermediate dose.DLT was graded according to CTCAE v4.0. Includes \>= Grade 3(G3) peripheral neuropathy,\>=G3 nausea/vomiting despite optimal anti-emetic treatment, any other non-hematologic toxicity of \>=G3(except alopecia, single abnormal laboratory values Investigator judged unlikely related to study therapy, had no clinical correla
Interventions
- DRUG FOLFIRI
- DRUG E7820
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2011-09-30 |
| Est. Completion | 2015-06-22 |
| Phase | Phase 1 |
Why NCT01347645 stopped before completion
NCT01347645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% higher).
The record links to 0 conditions, and to 2 interventions - of which FOLFIRI is the first listed.
NCT01347645 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01347645 about?
NCT01347645 is a clinical study titled "Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal 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 NCT01347645?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 82 participants. The study started on 2011-09-30. Estimated completion is 2015-06-22.
What interventions are being tested in trial NCT01347645?
The interventions under investigation include: FOLFIRI (DRUG), E7820 (DRUG).
Who is sponsoring clinical trial NCT01347645?
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 NCT01347645's enrollment target sits among peer trials
82 669th of 2000 higher than 1,330 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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