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NCT01533181 · ClinicalTrials.gov registry record · Phase 2

Linsitinib or Topotecan Hydrochloride in Treating Patients With Relapsed Small Cell Lung Cancer

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
44
Enrollment target

NCT01533181: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT01533181 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01533181, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
44 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate how OSI-906 compares to Topotecan in trying to slow down the growth and/or progression of the tumors of participants with relapsed or recurrent Small Cell Lung Cancer. This study also plans to find out what effects, good or bad (side effects), OSI-906 has on participants and or Small Cell Lung Cancer. The study will also investigate if some proteins measured in the blood or tumor and some imaging features obtained from computed tomography (CT) scans can help predict whether OSI-906 or topotecan will be effective against Small Cell Lung Cancer.

Primary Outcome

PFS: Time from randomization to time of disease progression or death. PFS summarized with the Kaplan-Meier (K-M) method by two arms (experimental versus control). Confidence intervals for the median PFS and PFS rates at different time points to be constructed when appropriate.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • OTHER Pharmacological Study
  • DRUG Topotecan Hydrochloride
  • DRUG Linsitinib

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2012-02
Est. Completion 2014-11
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT01533181 record still lists

NCT01533181 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT01533181 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01533181 about?

NCT01533181 is a clinical study titled "Linsitinib or Topotecan Hydrochloride in Treating Patients With Relapsed Small Cell Lung Cancer". The purpose of this study is to evaluate how OSI-906 compares to Topotecan in trying to slow down the growth and/or progression of the tumors of participants with relapsed or recurrent Small Cell Lung Cancer. This study also plans to find out what effects, good or bad (side effects), OSI-906 has on...

What is the current status of trial NCT01533181?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2012-02. Estimated completion is 2014-11.

What interventions are being tested in trial NCT01533181?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Pharmacological Study (OTHER), Topotecan Hydrochloride (DRUG), Linsitinib (DRUG).

Who is sponsoring clinical trial NCT01533181?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01533181's enrollment target sits among peer trials

44 1322nd of 2000 higher than 669 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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Source: ClinicalTrials.gov NCT01533181, the US trial registry maintained by the National Library of Medicine. NCT01533181 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.