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NCT01276613 · ClinicalTrials.gov registry record · Early Phase 1
Tissue Pharmacokinetics of Intraoperative Gemcitabine in Resectable Adenocarcinoma of the Pancreas
A Early Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 18
- Enrollment target
NCT01276613: Clinical Trial Early Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01276613 is a Early Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 18 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01276613, a Early Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if gemcitabine can enter pancreas cancer cells, to measure the amount of it that may enter the cells, and for biomarker testing. Biomarkers may be related to participant's reaction to the study drug.
Primary Outcome
Pharmacokinetic (PK) Testing of up to 10 blood samples (about 1 tablespoon each time) drawn during surgery starting before gemcitabine infusion and at end of surgery. Blood samples used to measure levels of gemcitabine in blood at the different time points.
Interventions
- DRUG Gemcitabine
- DRUG Losartan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-01 |
| Est. Completion | 2019-04-19 |
| Phase | Early Phase 1 |
Why NCT01276613 stopped before completion
NCT01276613 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 2 interventions - of which Gemcitabine is the first listed.
NCT01276613 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01276613 about?
NCT01276613 is a clinical study titled "Tissue Pharmacokinetics of Intraoperative Gemcitabine in Resectable Adenocarcinoma of the Pancreas". The goal of this clinical research study is to learn if gemcitabine can enter pancreas cancer cells, to measure the amount of it that may enter the cells, and for biomarker testing. Biomarkers may be related to participant's reaction to the study drug.
What is the current status of trial NCT01276613?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 18 participants. The study started on 2011-01. Estimated completion is 2019-04-19.
What interventions are being tested in trial NCT01276613?
The interventions under investigation include: Gemcitabine (DRUG), Losartan (DRUG).
Who is sponsoring clinical trial NCT01276613?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01276613's enrollment target sits among peer trials
18 1316th of 2000 higher than 651 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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