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NCT01244191 · ClinicalTrials.gov registry record · Phase 3
Tivantinib Plus Erlotinib Versus Placebo Plus Erlotinib for the Treatment of Non-squamous, Non-small-cell Lung Cancer
A Phase 3 study, sponsored by Daiichi Sankyo.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,048
- Enrollment target
NCT01244191: Clinical Trial Phase 3 study, sponsored by Daiichi Sankyo.
NCT01244191 is a Phase 3 study that was terminated before completion, run by Daiichi Sankyo. The registered enrollment target is 1,048 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01244191, a Phase 3 study, was terminated before completion, sponsored by Daiichi Sankyo.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,048 participants
- Enrollment target
Study Summary
This study is to determine if the combination regimen of tivantinib with erlotinib will improve overall survival relative to erlotinib alone in subjects with locally advanced or metastatic non-squamous, non-small cell lung cancer who have received 1 or 2 prior systemic anti-cancer therapies.
Primary Outcome
The overall survival (OS) was defined as the time from the date of randomization to the date of death from any cause.
Interventions
- DRUG Placebo
- DRUG Erlotinib
- DRUG Tivantinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,048 participants |
| Start Date | 2011-01-11 |
| Est. Completion | 2012-12-15 |
| Phase | Phase 3 |
Why NCT01244191 stopped before completion
NCT01244191 is an interventional study that assigns participants to a tested intervention. Its 1,048 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01244191 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01244191 about?
NCT01244191 is a clinical study titled "Tivantinib Plus Erlotinib Versus Placebo Plus Erlotinib for the Treatment of Non-squamous, Non-small-cell Lung Cancer". This study is to determine if the combination regimen of tivantinib with erlotinib will improve overall survival relative to erlotinib alone in subjects with locally advanced or metastatic non-squamous, non-small cell lung cancer who have received 1 or 2 prior systemic anti-cancer therapies.
What is the current status of trial NCT01244191?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,048 participants. The study started on 2011-01-11. Estimated completion is 2012-12-15.
What interventions are being tested in trial NCT01244191?
The interventions under investigation include: Placebo (DRUG), Erlotinib (DRUG), Tivantinib (DRUG).
Who is sponsoring clinical trial NCT01244191?
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 NCT01244191's enrollment target sits among peer trials
1,048 283rd of 2000 higher than 1,718 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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