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NCT00553332 · ClinicalTrials.gov registry record · Phase 2
Selumetinib in Treating Patients With Biliary Cancer That Cannot Be Removed By Surgery
A Phase 2 study of Liver and Intrahepatic Biliary Tract Cancer and Recurrent Extrahepatic Bile Duct Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
- 7
- Study locations
NCT00553332: Completed Phase 2 study of Liver and Intrahepatic Biliary Tract Cancer and Recurrent Extrahepatic Bile Duct Cancer, sponsored by National Cancer Institute (NCI).
NCT00553332 is a Phase 2 study of Liver and Intrahepatic Biliary Tract Cancer and Recurrent Extrahepatic Bile Duct Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00553332, a Phase 2 study of Liver and Intrahepatic Biliary Tract Cancer and Recurrent Extrahepatic Bile Duct Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
- 7
- Study locations
Study Summary
This phase II trial is studying how well selumetinib works in treating patients with biliary cancer that cannot be removed by surgery. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- DRUG selumetinib
Study Locations (7)
Michigan
- University of Michigan Cancer Center (UMCC) Research Base - Ann Arbor
- Wayne State University - Detroit
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Georgia
- Emory University - Atlanta
North Carolina
- University of North Carolina - Chapel Hill
Ohio
- Ohio State University Medical Center - Columbus
Tennessee
- Vanderbilt University - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2007-11 |
| Est. Completion | 2013-01 |
| Phase | Phase 2 |
What the finished NCT00553332 record still lists
NCT00553332 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).
The record links to 3 conditions, with Liver and Intrahepatic Biliary Tract Cancer appearing as the primary indexed condition, and to 2 interventions - of which laboratory biomarker analysis is the first listed.
NCT00553332 lists 7 locations in 6 states (Michigan, Florida, Georgia).
Frequently Asked Questions
What is clinical trial NCT00553332 about?
NCT00553332 is a clinical study titled "Selumetinib in Treating Patients With Biliary Cancer That Cannot Be Removed By Surgery". This phase II trial is studying how well selumetinib works in treating patients with biliary cancer that cannot be removed by surgery. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
What is the current status of trial NCT00553332?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2007-11. Estimated completion is 2013-01.
What conditions does trial NCT00553332 study?
This clinical trial studies the following conditions: Liver and Intrahepatic Biliary Tract Cancer, Recurrent Extrahepatic Bile Duct Cancer, Unresectable Extrahepatic Bile Duct Cancer.
What interventions are being tested in trial NCT00553332?
The interventions under investigation include: laboratory biomarker analysis (OTHER), selumetinib (DRUG).
Who is sponsoring clinical trial NCT00553332?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00553332 being conducted?
This trial has 7 study locations across Florida, Georgia, Michigan, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00553332's enrollment target sits among peer trials
29 1669th of 2000 higher than 324 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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