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NCT01013597 · ClinicalTrials.gov registry record · Phase 2

Trial of LBH589 in Metastatic Thyroid Cancer

A Phase 2 study, sponsored by University of Wisconsin, Madison.

Completed
Registry status
Phase 2
Development phase
13
Enrollment target

NCT01013597: Completed Phase 2 study, sponsored by University of Wisconsin, Madison.

NCT01013597 is a Phase 2 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01013597, a Phase 2 study, has completed, sponsored by University of Wisconsin, Madison.

COMPLETED
Registry status
Phase 2
Development phase
13 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the tumor response rate in patients with metastatic medullary thyroid cancer (MTC) or radioiodine resistant differentiated thyroid cancer (DTC) after receiving treatment with LBH589 20 mg by mouth, three times weekly. Time to progression, overall survival, toxicity, tolerability, and Notch1 protein expression patterns will also be evaluated.

Primary Outcome

per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v.1.0) for target lesions and assessed by CT/MRI: "Response" includes Complete Response (CR, disappearance of all target lesions), or Partial Response (PR, \>=30% decrease in the sum of the longest diameter of target lesions). "No Response" includes Stable Disease (SD, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease), and Progressive Disease (PD, at least a 20

Interventions

  • DRUG LBH589

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2010-01
Est. Completion 2016-02
Phase Phase 2
University of Wisconsin, Madison

1,039 total trials

What the finished NCT01013597 record still lists

NCT01013597 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 1 intervention - of which LBH589 is the first listed.

NCT01013597 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01013597 about?

NCT01013597 is a clinical study titled "Trial of LBH589 in Metastatic Thyroid Cancer". The purpose of this study is to evaluate the tumor response rate in patients with metastatic medullary thyroid cancer (MTC) or radioiodine resistant differentiated thyroid cancer (DTC) after receiving treatment with LBH589 20 mg by mouth, three times weekly. Time to progression, overall survival, to...

What is the current status of trial NCT01013597?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2010-01. Estimated completion is 2016-02.

What interventions are being tested in trial NCT01013597?

The interventions under investigation include: LBH589 (DRUG).

Who is sponsoring clinical trial NCT01013597?

This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01013597's enrollment target sits among peer trials

13 1947th of 2000 higher than 53 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 NCT01013597, the US trial registry maintained by the National Library of Medicine. NCT01013597 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.