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NCT01025453 · ClinicalTrials.gov registry record · Phase 2

Combination of Temsirolimus and Sorafenib in the Treatment of Radioactive Iodine Refractory Thyroid Cancer

A Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.

Completed
Registry status
Phase 2
Development phase
37
Enrollment target

NCT01025453: Completed Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.

NCT01025453 is a Phase 2 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01025453, a Phase 2 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
37 participants
Enrollment target

Study Summary

The purpose of this study is to find out what effects, good and/or bad, the combination of sorafenib and temsirolimus will have on thyroid cancer. Treatment guidelines from the National Comprehensive Cancer Network include sorafenib as a treatment option for thyroid cancer. Temsirolimus is an intravenous medication that is FDA approved for other type of cancers. In laboratory studies, the addition of temsirolimus to sorafenib works better than sorafenib alone.

Primary Outcome

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Interventions

  • DRUG Temsirolimus and Sorafenib

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2009-12-01
Est. Completion 2018-01-16
Phase Phase 2
Memorial Sloan Kettering Cancer Center

1,884 total trials

What the finished NCT01025453 record still lists

NCT01025453 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).

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

NCT01025453 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01025453 about?

NCT01025453 is a clinical study titled "Combination of Temsirolimus and Sorafenib in the Treatment of Radioactive Iodine Refractory Thyroid Cancer". The purpose of this study is to find out what effects, good and/or bad, the combination of sorafenib and temsirolimus will have on thyroid cancer. Treatment guidelines from the National Comprehensive Cancer Network include sorafenib as a treatment option for thyroid cancer. Temsirolimus is an intra...

What is the current status of trial NCT01025453?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2009-12-01. Estimated completion is 2018-01-16.

What interventions are being tested in trial NCT01025453?

The interventions under investigation include: Temsirolimus and Sorafenib (DRUG).

Who is sponsoring clinical trial NCT01025453?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01025453's enrollment target sits among peer trials

37 1484th of 2000 higher than 505 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 NCT01025453, the US trial registry maintained by the National Library of Medicine. NCT01025453 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.