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NCT01455389 · ClinicalTrials.gov registry record · Phase 1

TUSC2-nanoparticles and Erlotinib in Stage IV Lung Cancer

A Phase 1 study, sponsored by Genprex.

Terminated
Registry status
Phase 1
Development phase
25
Enrollment target

NCT01455389 is a Phase 1 study that was terminated before completion, run by Genprex. The registered enrollment target is 25 participants.

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The verdict

NCT01455389, a Phase 1 study, was terminated before completion, sponsored by Genprex.

TERMINATED
Registry status
Phase 1
Development phase
25 participants
Enrollment target

Study Summary

The goal of phase 1 of this clinical research study is to find the highest dose of DOTAP:Chol-TUSC2 that can be safely given in combination with Tarceva (erlotinib hydrochloride) to patients with NSCLC. The goal of phase 2 of this clinical research study is to learn if the combination of DOTAP:Chol-TUSC2 and erlotinib hydrochloride can help to control NSCLC. The safety of this drug combination will also be studied in both phases. DOTAP:Chol-TUSC2 (previously FUS1) is a drug that helps transfer a gene called TUSC2 into cancer cells. Researchers think that cells without this gene may be involved in the development of lung cancer tumors. They want to find out if replacing the gene in these cells may keep the tissue from forming cancer cells. Erlotinib hydrochloride is designed to block a protein on tumor cells that may control tumor growth and survival. This may stop tumors from growing.

Interventions

  • DRUG Dexamethasone
  • DRUG Diphenhydramine
  • DRUG Erlotinib
  • DRUG DOTAP:Chol-TUSC2

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2014-02
Est. Completion 2020-09-28
Phase Phase 1

Sponsor

Genprex

4 total trials

What the Registry Record Tells You About NCT01455389

The ClinicalTrials.gov registry entry for NCT01455389 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genprex, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Dexamethasone is the first listed.

NCT01455389 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01455389 about?

NCT01455389 is a clinical study titled "TUSC2-nanoparticles and Erlotinib in Stage IV Lung Cancer". The goal of phase 1 of this clinical research study is to find the highest dose of DOTAP:Chol-TUSC2 that can be safely given in combination with Tarceva (erlotinib hydrochloride) to patients with NSCLC. The goal of phase 2 of this clinical research study is to learn if the combination of DOTAP:Chol...

What is the current status of trial NCT01455389?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2014-02. Estimated completion is 2020-09-28.

What interventions are being tested in trial NCT01455389?

The interventions under investigation include: Dexamethasone (DRUG), Diphenhydramine (DRUG), Erlotinib (DRUG), DOTAP:Chol-TUSC2 (DRUG).

Who is sponsoring clinical trial NCT01455389?

This trial is sponsored by Genprex, which has 4 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.