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Azacitidine and Entinostat in Treating Patients With Recurrent Advanced Non-Small Cell Lung Cancer
NCT00387465 · View on ClinicalTrials.gov ↗
Study Summary
This phase I/II trial is studying the side effects and best dose of azacitidine when given together with entinostat and to see how well they work in treating patients with recurrent advanced non-small cell lung cancer. Azacitidine and entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving azacitidine together with entinostat may kill more tumor cells.
Conditions Studied
Interventions
- DRUG Entinostat
- DRUG Azacitidine 30mg/m2
- DRUG Azacitidine 40mg/m2
Study Locations (5)
Maryland
- Johns Hopkins Bayview Medical Center — Baltimore
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital — Baltimore
- Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center — Baltimore
California
- USC Norris Comprehensive Cancer Center — Los Angeles
- Sidney Kimmel Cancer Center — San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2006-08 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00387465
The ClinicalTrials.gov registry entry for NCT00387465 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Recurrent Non-Small Cell Lung Carcinoma appearing as the primary indexed condition, and to 3 interventions — of which Entinostat is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00387465 reports 5 study locations spanning 2 distinct geographic areas — top geographies include Maryland, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00387465 about?
NCT00387465 is a clinical study titled "Azacitidine and Entinostat in Treating Patients With Recurrent Advanced Non-Small Cell Lung Cancer". This phase I/II trial is studying the side effects and best dose of azacitidine when given together with entinostat and to see how well they work in treating patients with recurrent advanced non-small cell lung cancer. Azacitidine and entinostat may stop the growth of tumor cells by blocking some of...
What is the current status of trial NCT00387465?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 94 participants. The study started on 2006-08. Estimated completion is 2014-11.
What conditions does trial NCT00387465 study?
This clinical trial studies the following conditions: Recurrent Non-Small Cell Lung Carcinoma, Stage IV Non-Small Cell Lung Cancer, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00387465?
The interventions under investigation include: Entinostat (DRUG), Azacitidine 30mg/m2 (DRUG), Azacitidine 40mg/m2 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00387465?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00387465 being conducted?
This trial has 5 study locations across California, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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