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NCT00955721 · ClinicalTrials.gov registry record · Phase 1
A Study of Combination of Gemcitabine, Oxaliplatin (GEMOX)-Sorafenib in Patients With Advanced Biliary Tract Cancer
A Phase 1 study, sponsored by University of Miami.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT00955721: Clinical Trial Phase 1 study, sponsored by University of Miami.
NCT00955721 is a Phase 1 study that was terminated before completion, run by University of Miami. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00955721, a Phase 1 study, was terminated before completion, sponsored by University of Miami.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
The purpose of this study is to build on the efficacy of the GEMOX regimen by adding Sorafenib in the treatment of Biliary Tract Cancer. Since there is no data on the combination of these three agents, the investigators plan to evaluate the safety in a run-in phase I portion in order to define the recommended phase II dose (RPTD). The phase II trial will enroll 40 patients at the RPTD level within 2 years in order to provide a preliminary estimate of progression-free survival (primary endpoint of the trial) in the target population.
Primary Outcome
Establish the recommended phase II dose (RPTD) of the combination of sorafenib and GEMOX in patients with advanced biliary tract cancer (BTC).
Interventions
- DRUG Oxaliplatin
- DRUG Gemcitabine
- DRUG Sorafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2009-08 |
| Est. Completion | 2014-07 |
| Phase | Phase 1 |
Why NCT00955721 stopped before completion
NCT00955721 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 3 interventions - of which Oxaliplatin is the first listed.
NCT00955721 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00955721 about?
NCT00955721 is a clinical study titled "A Study of Combination of Gemcitabine, Oxaliplatin (GEMOX)-Sorafenib in Patients With Advanced Biliary Tract Cancer". The purpose of this study is to build on the efficacy of the GEMOX regimen by adding Sorafenib in the treatment of Biliary Tract Cancer. Since there is no data on the combination of these three agents, the investigators plan to evaluate the safety in a run-in phase I portion in order to define the r...
What is the current status of trial NCT00955721?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2009-08. Estimated completion is 2014-07.
What interventions are being tested in trial NCT00955721?
The interventions under investigation include: Oxaliplatin (DRUG), Gemcitabine (DRUG), Sorafenib (DRUG).
Who is sponsoring clinical trial NCT00955721?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00955721's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 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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