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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 is a Phase 2 study that was terminated before completion, run by Duke University. The registered enrollment target is 101 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00509366
The ClinicalTrials.gov registry entry for NCT00509366 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Cisplatin & Gemcitabine is the first listed.
NCT00509366 reports 0 study locations.
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.
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