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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 is a Phase 1 study that was terminated before completion, run by University of Miami. The registered enrollment target is 9 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00955721
The ClinicalTrials.gov registry entry for NCT00955721 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Oxaliplatin is the first listed.
NCT00955721 reports 0 study locations.
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.
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