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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: Clinical Trial Phase 1 study, sponsored by Genprex.
NCT01455389 is a Phase 1 study that was terminated before completion, run by Genprex. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
MTD defined as dose level at which less than 2 participants experience dose-limiting toxicity (DLT). Toxicity graded according to National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 4. DLT will be grade \> 3 toxicity occurring during the first cycle of therapy (i.e., within the first 3 weeks).
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 |
Why NCT01455389 stopped before completion
NCT01455389 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 4 interventions - of which Dexamethasone is the first listed.
NCT01455389 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01455389's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 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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