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NCT01434459 · ClinicalTrials.gov registry record · Phase 1
Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin
A Phase 1 study, sponsored by Emory University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01434459: Clinical Trial Phase 1 study, sponsored by Emory University.
NCT01434459 is a Phase 1 study that was terminated before completion, run by Emory University. 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
NCT01434459, a Phase 1 study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
Therasphere is a form of treatment that has been designed to selectively deliver radiation to the cancer within the patient's liver. This form of treatment has been used in a number of clinical trials and has been approved for use in the treatment of liver cancer. The investigators want to test the safety of using Gemcitabine (a chemotherapy drug) with TheraSphere (radioactive beads that are injected directly into the blood vessel supplying the tumor in the liver) in patients with advanced pancreatobiliary tumors such as pancreatic cancer or cholangiocarcinoma (bile duct tumors) involving the liver.
Primary Outcome
Patients will receive full dose therasphere. The gemcitabine dose will start out low and the dose will increase after first 3 patients if no significant side effects are observed. The investigators will continue to increase the dose of gemcitabine as long as the investigators do not observe side effects or until we reach full dose of gemcitabine.
Interventions
- DRUG Gemcitabine with TheraSphere
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-09 |
| Phase | Phase 1 |
Why NCT01434459 stopped before completion
NCT01434459 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 1 intervention - of which Gemcitabine with TheraSphere is the first listed.
NCT01434459 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01434459 about?
NCT01434459 is a clinical study titled "Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin". Therasphere is a form of treatment that has been designed to selectively deliver radiation to the cancer within the patient's liver. This form of treatment has been used in a number of clinical trials and has been approved for use in the treatment of liver cancer. The investigators want to test the...
What is the current status of trial NCT01434459?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2011-09. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01434459?
The interventions under investigation include: Gemcitabine with TheraSphere (DRUG).
Who is sponsoring clinical trial NCT01434459?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01434459'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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