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NCT00456261 · ClinicalTrials.gov registry record · Phase 2
First-Line Treatment of A Comparison of 2 Treatments in Elderly Patients With Advanced NSCLC
A Phase 2 study, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
NCT00456261: Completed Phase 2 study, sponsored by SCRI Development Innovations.
NCT00456261 is a Phase 2 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 110 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00456261, a Phase 2 study, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
Study Summary
This trial will look at 2 different drug combinations that have well known safety profiles and are known to be active against non small cell lung cancer and combine them with bevacizumab, an experimental drug that has shown effectiveness when added to other drug combinations for advanced non-small cell lung cancer. The primary objective in this study is to see how well this combination of drugs keeps the cancer from getting worse in this elderly population of non-small cell lung cancer patients.
Primary Outcome
Time to Progression (TTP) is defined as the interval between the date of treatment initiation and the date of progressive disease. Progression is defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or unequivocal progression of non-target lesions or the appearance of one or more new lesi
Interventions
- DRUG Bevacizumab
- DRUG Carboplatin
- DRUG Pemetrexed
- DRUG Gemcitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2007-03 |
| Est. Completion | 2012-09 |
| Phase | Phase 2 |
What the finished NCT00456261 record still lists
NCT00456261 is an interventional study that assigns participants to a tested intervention. The registered 110 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 (17% lower).
The record links to 0 conditions, and to 4 interventions - of which Bevacizumab is the first listed.
NCT00456261 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00456261 about?
NCT00456261 is a clinical study titled "First-Line Treatment of A Comparison of 2 Treatments in Elderly Patients With Advanced NSCLC". This trial will look at 2 different drug combinations that have well known safety profiles and are known to be active against non small cell lung cancer and combine them with bevacizumab, an experimental drug that has shown effectiveness when added to other drug combinations for advanced non-small c...
What is the current status of trial NCT00456261?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2007-03. Estimated completion is 2012-09.
What interventions are being tested in trial NCT00456261?
The interventions under investigation include: Bevacizumab (DRUG), Carboplatin (DRUG), Pemetrexed (DRUG), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT00456261?
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 NCT00456261's enrollment target sits among peer trials
110 632nd of 2000 higher than 1,361 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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