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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2014-02 |
| Est. Completion | 2020-09-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗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.
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