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NCT00434109 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization
A Phase 2 study of Neuroendocrine Tumor and Islet Cell Tumor, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
- 1
- Study location
NCT00434109: Completed Phase 2 study of Neuroendocrine Tumor and Islet Cell Tumor, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT00434109 is a Phase 2 study of Neuroendocrine Tumor and Islet Cell Tumor that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 39 participants, below the 138-participant average among 6 other Neuroendocrine Tumor trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00434109, a Phase 2 study of Neuroendocrine Tumor and Islet Cell Tumor, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to decide if a medicine that slows growth of new blood vessels can be give after the embolization procedure to prevent or delay new growth of blood vessels to tumors.
Primary Outcome
Kaplan-Meier analysis of PFS. Progression-free survival rate at 12 months after first embolization. PFS was defined as time from start of treatment until disease progression or death as a result of any cause. Response and progression endpoints refer specifically to hepatic metastases. Extrahepatic metastases were included for assessment of response and progression by RECIST version 1.0. Progressive Disease (PD): At least a 20% increase in the SLD of target lesions, taking as reference the smalle
Conditions Studied
Interventions
- DRUG Sunitinib malate
- PROCEDURE Hepatic Artery Embolizations
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center & Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2006-11 |
| Est. Completion | 2012-02 |
| Phase | Phase 2 |
What the finished NCT00434109 record still lists
NCT00434109 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 138-participant average among 6 other Neuroendocrine Tumor trials with a reported enrollment target (72% lower).
The record links to 2 conditions, with Neuroendocrine Tumor appearing as the primary indexed condition, and to 2 interventions - of which Sunitinib malate is the first listed.
NCT00434109 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT00434109 about?
NCT00434109 is a clinical study titled "Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization". The purpose of this study is to decide if a medicine that slows growth of new blood vessels can be give after the embolization procedure to prevent or delay new growth of blood vessels to tumors.
What is the current status of trial NCT00434109?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2006-11. Estimated completion is 2012-02.
What conditions does trial NCT00434109 study?
This clinical trial studies the following conditions: Neuroendocrine Tumor, Islet Cell Tumor.
What interventions are being tested in trial NCT00434109?
The interventions under investigation include: Sunitinib malate (DRUG), Hepatic Artery Embolizations (PROCEDURE).
Who is sponsoring clinical trial NCT00434109?
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 NCT00434109 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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