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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.

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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

FieldValue
Enrollment Target 140 participants
Start Date 2011-04
Est. Completion 2013-06
Phase Phase 2

Sponsor

CytRx

6 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.