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NCT01434069 · ClinicalTrials.gov registry record · Phase 1
Phase I Trial of Combination of FOLFIRI and SOM 230
A Phase 1 study of Gastrointestinal Tumor, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT01434069: Completed Phase 1 study of Gastrointestinal Tumor, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01434069 is a Phase 1 study of Gastrointestinal Tumor that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01434069, a Phase 1 study of Gastrointestinal Tumor, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-arm, open-label, phase I study of combination therapy with SOM 230 and FOLFIRI. We will utilize a sequential dose-escalation design to define the maximum tolerated dose (MTD) of SOM 230 when combined with standard doses of FOLFIRI.
Primary Outcome
To determine the maximum tolerated dose (using a standard 3+3 design), of SOM 230 and FOLFIRI.
Conditions Studied
Interventions
- DRUG SOM230C LAR
- DRUG FOLFIRI Infusion
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2011-09 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
What the finished NCT01434069 record still lists
NCT01434069 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Gastrointestinal Tumor appearing as the primary indexed condition, and to 2 interventions - of which SOM230C LAR is the first listed.
NCT01434069 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01434069 about?
NCT01434069 is a clinical study titled "Phase I Trial of Combination of FOLFIRI and SOM 230". This is a single-arm, open-label, phase I study of combination therapy with SOM 230 and FOLFIRI. We will utilize a sequential dose-escalation design to define the maximum tolerated dose (MTD) of SOM 230 when combined with standard doses of FOLFIRI.
What is the current status of trial NCT01434069?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2011-09. Estimated completion is 2015-12.
What conditions does trial NCT01434069 study?
This clinical trial studies the following conditions: Gastrointestinal Tumor.
What interventions are being tested in trial NCT01434069?
The interventions under investigation include: SOM230C LAR (DRUG), FOLFIRI Infusion (DRUG).
Who is sponsoring clinical trial NCT01434069?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01434069 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01434069's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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