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NCT00509366 · ClinicalTrials.gov registry record · Phase 2
Study Using a Genomic Predictor of Platinum Resistance to Guide Therapy in Stage IIIB/IV Non-Small Cell Lung Cancer
A Phase 2 study, sponsored by Duke University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 101
- Enrollment target
NCT00509366: Clinical Trial Phase 2 study, sponsored by Duke University.
NCT00509366 is a Phase 2 study that was terminated before completion, run by Duke University. The registered enrollment target is 101 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00509366, a Phase 2 study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 101 participants
- Enrollment target
Study Summary
In this trial, subjects with chemo-naive advanced non-small cell lung cancer (NSCLC) were assigned to chemotherapy using a genomic-based predictor for platinum sensitivity. After an amendment dated 1/25/2010, subjects with squamous cell NSCLC sensitive to cisplatin received cisplatin/gemcitabine and if resistant to cisplatin received docetaxel/gemcitabine. Subjects with non-squamous cell NSCLC sensitive to cisplatin received cisplatin/pemetrexed and if resistant to cisplatin received pemetrexed/gemcitabine. The primary objective of this trial was to prospectively validate the genomic-based prediction model through separate evaluation of the one-year progression-free survival (PFS) of the cisplatin-sensitive and cisplatin-resistant cohorts. Secondary objectives included: assessment of overall time to progressive disease, quality of life and evaluation of drug sensitivity patterns of cisplatin and pemetrexed.
Primary Outcome
One-year progression-free survival was defined from the time from initiation of study treatment to the first date of disease progression or death as a result of any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time was censored at the date of the last follow-up visit for patients who were still alive and
Interventions
- DRUG Cisplatin & Gemcitabine
- DRUG Cisplatin & Pemetrexed
- DRUG Docetaxel & Gemcitabine
- DRUG Pemetrexed & Gemcitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2007-05 |
| Est. Completion | 2011-12 |
| Phase | Phase 2 |
Why NCT00509366 stopped before completion
NCT00509366 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower).
The record links to 0 conditions, and to 4 interventions - of which Cisplatin & Gemcitabine is the first listed.
NCT00509366 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00509366 about?
NCT00509366 is a clinical study titled "Study Using a Genomic Predictor of Platinum Resistance to Guide Therapy in Stage IIIB/IV Non-Small Cell Lung Cancer". In this trial, subjects with chemo-naive advanced non-small cell lung cancer (NSCLC) were assigned to chemotherapy using a genomic-based predictor for platinum sensitivity. After an amendment dated 1/25/2010, subjects with squamous cell NSCLC sensitive to cisplatin received cisplatin/gemcitabine and...
What is the current status of trial NCT00509366?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 101 participants. The study started on 2007-05. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00509366?
The interventions under investigation include: Cisplatin & Gemcitabine (DRUG), Cisplatin & Pemetrexed (DRUG), Docetaxel & Gemcitabine (DRUG), Pemetrexed & Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT00509366?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00509366's enrollment target sits among peer trials
101 672nd of 2000 higher than 1,329 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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