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NCT00193414 · ClinicalTrials.gov registry record · Phase 2
Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer
A Phase 2 study, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
NCT00193414: Completed Phase 2 study, sponsored by SCRI Development Innovations.
NCT00193414 is a Phase 2 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 72 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00193414, a Phase 2 study, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
Study Summary
This study is designed to study the role of an active and well-tolerated non-platinum agent, gemcitabine, in a combination regimen with pemetrexed in the first-line treatment of advanced NSCLC. This study will serve to define the role of next generation agents in a new combination regimen in the treatment of advanced NSCLC. This combination regimen may ultimately be important in further expanding treatment options for patients while improving survival, quality of life, and symptom control compared with platinum-based combination regimens - and with acceptable toxicity.
Primary Outcome
Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.
Interventions
- DRUG Pemetrexed
- DRUG Gemcitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2005-05 |
| Est. Completion | 2009-08 |
| Phase | Phase 2 |
What the finished NCT00193414 record still lists
NCT00193414 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 2 interventions - of which Pemetrexed is the first listed.
NCT00193414 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00193414 about?
NCT00193414 is a clinical study titled "Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer". This study is designed to study the role of an active and well-tolerated non-platinum agent, gemcitabine, in a combination regimen with pemetrexed in the first-line treatment of advanced NSCLC. This study will serve to define the role of next generation agents in a new combination regimen in the tre...
What is the current status of trial NCT00193414?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2005-05. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00193414?
The interventions under investigation include: Pemetrexed (DRUG), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT00193414?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00193414's enrollment target sits among peer trials
72 925th of 2000 higher than 1,065 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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