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NCT00126672 · ClinicalTrials.gov registry record · Phase 2

Rapamycin FOR Kidney Angiomyolipomas

A Phase 2 study, sponsored by Dana-Farber Cancer Institute.

Completed
Registry status
Phase 2
Development phase
36
Enrollment target

NCT00126672: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.

NCT00126672 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00126672, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.

COMPLETED
Registry status
Phase 2
Development phase
36 participants
Enrollment target

Study Summary

This research study is evaluating a drug called rapamycin as a possible treatment for the lumps (or tumors) that form in the kidneys, called angiomyolipomas, in people who have either TSC or LAM. Kidney angiomyolipomas are tumors that are made up of blood vessels, muscle and fat. Rapamycin has been approved to treat other diseases, but it is investigational for treating kidney angiomyolipomas. Investigational means that it is being as a possible treatment for kidney angiomyolipomas but is not currently approved by the U.S. Food and Drug Administration (FDA) for treating this disease.

Primary Outcome

The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluati

Interventions

  • DRUG Rapamycin

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2005-12-20
Est. Completion 2010-04
Phase Phase 2
Dana-Farber Cancer Institute

781 total trials

What the finished NCT00126672 record still lists

NCT00126672 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).

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

NCT00126672 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00126672 about?

NCT00126672 is a clinical study titled "Rapamycin FOR Kidney Angiomyolipomas". This research study is evaluating a drug called rapamycin as a possible treatment for the lumps (or tumors) that form in the kidneys, called angiomyolipomas, in people who have either TSC or LAM. Kidney angiomyolipomas are tumors that are made up of blood vessels, muscle and fat. Rapamycin has been ...

What is the current status of trial NCT00126672?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2005-12-20. Estimated completion is 2010-04.

What interventions are being tested in trial NCT00126672?

The interventions under investigation include: Rapamycin (DRUG).

Who is sponsoring clinical trial NCT00126672?

This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00126672's enrollment target sits among peer trials

36 1496th of 2000 higher than 477 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 NCT00126672, the US trial registry maintained by the National Library of Medicine. NCT00126672 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.