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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 is a Phase 2 study that was terminated before completion, run by CytRx. The registered enrollment target is 140 participants.
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).
Interventions
- DRUG Placebo
- DRUG Tamibarotene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2011-04 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01337154
The ClinicalTrials.gov registry entry for NCT01337154 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CytRx, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01337154 reports 0 study locations.
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.
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