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NCT01211483 · ClinicalTrials.gov registry record · Phase 1
Study of Erlotinib With or Without Investigational Drug (U3-1287) in Subjects With Advanced Non-small Cell Lung Cancer
A Phase 1 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 1
- Development phase
- 222
- Enrollment target
NCT01211483: Completed Phase 1 study, sponsored by Daiichi Sankyo.
NCT01211483 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 222 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (270% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01211483, a Phase 1 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 222 participants
- Enrollment target
Study Summary
This is a Phase 1b/2 study. In Phase 1b, subjects will know the treatment they are receiving. Subjects will receive Erlotinib + U3-1287. The Phase 1b portion will determine if adding U3-1287 to Erlotinib will be safe in subjects with advanced non-small cell lung cancer who fail prior treatment. In the Phase 2 portion, subjects will be blinded to the treatments they are receiving. Subjects will receive either Erlotinib alone or Erlotinib + U3-1287. The Phase 2 portion will determine if adding U3-1287 to Erlotinib will be safe and improve survival in subjects with advanced non-small cell lung cancer who failed the first treatment.
Primary Outcome
Progression-free survival (PFS) was defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression or death due to any cause (as per Response Evaluation Criteria in Solid Tumors \[RECIST\] Version 1.1).
Interventions
- DRUG Placebo
- DRUG Erlotinib
- DRUG U3-1287
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2010-09 |
| Est. Completion | 2013-11-23 |
| Phase | Phase 1 |
What the finished NCT01211483 record still lists
NCT01211483 is an interventional study that assigns participants to a tested intervention. The registered 222 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (270% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01211483 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01211483 about?
NCT01211483 is a clinical study titled "Study of Erlotinib With or Without Investigational Drug (U3-1287) in Subjects With Advanced Non-small Cell Lung Cancer". This is a Phase 1b/2 study. In Phase 1b, subjects will know the treatment they are receiving. Subjects will receive Erlotinib + U3-1287. The Phase 1b portion will determine if adding U3-1287 to Erlotinib will be safe in subjects with advanced non-small cell lung cancer who fail prior treatment. In t...
What is the current status of trial NCT01211483?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 222 participants. The study started on 2010-09. Estimated completion is 2013-11-23.
What interventions are being tested in trial NCT01211483?
The interventions under investigation include: Placebo (DRUG), Erlotinib (DRUG), U3-1287 (DRUG).
Who is sponsoring clinical trial NCT01211483?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01211483's enrollment target sits among peer trials
222 229th of 2000 higher than 1,771 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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