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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 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 222 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01211483
The ClinicalTrials.gov registry entry for NCT01211483 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 222 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01211483 reports 0 study locations.
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.
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