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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 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. The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01434069
The ClinicalTrials.gov registry entry for NCT01434069 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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