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NCT02514421 · ClinicalTrials.gov registry record · Phase 1

Evaluation of Safety and Efficacy of Electrochemotherapy in the Treatment of Pancreatic Adenocarcinoma

A Phase 1 study, sponsored by The University of Texas Health Science Center, Houston.

Completed
Registry status
Phase 1
Development phase
6
Enrollment target

NCT02514421: Completed Phase 1 study, sponsored by The University of Texas Health Science Center, Houston.

NCT02514421 is a Phase 1 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02514421, a Phase 1 study, has completed, sponsored by The University of Texas Health Science Center, Houston.

COMPLETED
Registry status
Phase 1
Development phase
6 participants
Enrollment target

Study Summary

The purpose of this study is to see how well electrochemotherapy works at treating people with Stage III pancreatic adenocarcinoma. Electrochemotherapy is a treatment that combines electroporation and chemotherapy administration. Electroporation uses an electric current to produce holes in pancreatic tumor, which causes the tumor cells to die or take up a higher concentration of administered chemotherapy agent. This study will test the safety and look at the effect of electrochemotherapy in the treatment of stage III pancreatic adenocarcinoma. This study will also help to find the safest and most effective amount of electroporation voltage to apply to this type of tumor.

Primary Outcome

A dose limiting toxicity (DLT) is any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0) that is possibly related to the electrochemotherapy treatment. CTCAE 4.0 Grade 3 is a severe AE and Grade 4 is a life-threatening or disabling AE. DLTs are collected to determine the Maximum Tolerated Dose (MTD), which is defined as as one field strength level less than the field strength at which two or more patients out of six total patients exp

Interventions

  • DRUG nab-paclitaxel
  • DRUG gemcitabine
  • DEVICE Electroporation

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2015-07
Est. Completion 2017-04-18
Phase Phase 1

What the finished NCT02514421 record still lists

NCT02514421 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 3 interventions - of which nab-paclitaxel is the first listed.

NCT02514421 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02514421 about?

NCT02514421 is a clinical study titled "Evaluation of Safety and Efficacy of Electrochemotherapy in the Treatment of Pancreatic Adenocarcinoma". The purpose of this study is to see how well electrochemotherapy works at treating people with Stage III pancreatic adenocarcinoma. Electrochemotherapy is a treatment that combines electroporation and chemotherapy administration. Electroporation uses an electric current to produce holes in pancreati...

What is the current status of trial NCT02514421?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2015-07. Estimated completion is 2017-04-18.

What interventions are being tested in trial NCT02514421?

The interventions under investigation include: nab-paclitaxel (DRUG), gemcitabine (DRUG), Electroporation (DEVICE).

Who is sponsoring clinical trial NCT02514421?

This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02514421's enrollment target sits among peer trials

6 1974th of 2000 higher than 12 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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Source: ClinicalTrials.gov NCT02514421, the US trial registry maintained by the National Library of Medicine. NCT02514421 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.