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NCT01337154 · ClinicalTrials.gov registry record · Phase 2
First Line Study of Tamibarotene in Combination for Advanced Non-Small Cell Lung Cancer
A Phase 2 study, sponsored by CytRx.
- Terminated
- Registry status
- Phase 2
- Development phase
- 140
- Enrollment target
NCT01337154: Clinical Trial Phase 2 study, sponsored by CytRx.
NCT01337154 is a Phase 2 study that was terminated before completion, run by CytRx. The registered enrollment target is 140 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01337154, a Phase 2 study, was terminated before completion, sponsored by CytRx.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 140 participants
- Enrollment target
Study Summary
The goal of this study is to determine the progression-free survival and objective response rate in subjects with either stage IIIB with pleural effusion NSCLC or stage IV NSCLC who are treated with up to six cycles of paclitaxel plus carboplatin and either tamibarotene or placebo. Subjects will be randomly assigned to receive tamibarotene, 6 mg/m2, divided as twice daily orally, or an equal number of matching placebo tablets, starting 1 week before chemotherapy and continuing through all 6 cycles and beyond. Subjects will be assessed for response on Day 50, Day 113, then every other month using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Primary Outcome
Progression-free survival (PFS) is defined as the time from enrollment (i.e., assignment of subject ID number) to first documentation of objective tumor progression or to death due to any cause in the absence of previous documentation of objective tumor progression.
Interventions
- DRUG Placebo
- DRUG Tamibarotene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2011-04 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
Why NCT01337154 stopped before completion
NCT01337154 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01337154 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01337154 about?
NCT01337154 is a clinical study titled "First Line Study of Tamibarotene in Combination for Advanced Non-Small Cell Lung Cancer". The goal of this study is to determine the progression-free survival and objective response rate in subjects with either stage IIIB with pleural effusion NSCLC or stage IV NSCLC who are treated with up to six cycles of paclitaxel plus carboplatin and either tamibarotene or placebo. Subjects will be ...
What is the current status of trial NCT01337154?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2011-04. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01337154?
The interventions under investigation include: Placebo (DRUG), Tamibarotene (DRUG).
Who is sponsoring clinical trial NCT01337154?
This trial is sponsored by CytRx, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01337154's enrollment target sits among peer trials
140 512th of 2000 higher than 1,476 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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