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NCT00826241 · ClinicalTrials.gov registry record · Phase 2

Dose-Dense Temozolomide + Lapatinib for Recurrent Ependymoma

A Phase 2 study, sponsored by National Institutes of Health Clinical Center (CC).

Completed
Registry status
Phase 2
Development phase
58
Enrollment target

NCT00826241: Completed Phase 2 study, sponsored by National Institutes of Health Clinical Center (CC).

NCT00826241 is a Phase 2 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 58 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00826241, a Phase 2 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).

COMPLETED
Registry status
Phase 2
Development phase
58 participants
Enrollment target

Study Summary

The goal of this clinical research study is to learn if lapatinib when given in combination with temozolomide can help to control ependymoma that has come back after treatment. The safety of this combination will also be studied.

Primary Outcome

Time to progression defined as progressive disease, toxicity at a level of severity that precludes the patient continuing on the protocol, or death. Progression is a 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly

Interventions

  • DRUG Temozolomide
  • DRUG Lapatinib

Trial Details

FieldValue
Enrollment Target 58 participants
Start Date 2009-01
Est. Completion 2018-07-31
Phase Phase 2

What the finished NCT00826241 record still lists

NCT00826241 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).

The record links to 0 conditions, and to 2 interventions - of which Temozolomide is the first listed.

NCT00826241 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00826241 about?

NCT00826241 is a clinical study titled "Dose-Dense Temozolomide + Lapatinib for Recurrent Ependymoma". The goal of this clinical research study is to learn if lapatinib when given in combination with temozolomide can help to control ependymoma that has come back after treatment. The safety of this combination will also be studied.

What is the current status of trial NCT00826241?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2009-01. Estimated completion is 2018-07-31.

What interventions are being tested in trial NCT00826241?

The interventions under investigation include: Temozolomide (DRUG), Lapatinib (DRUG).

Who is sponsoring clinical trial NCT00826241?

This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00826241's enrollment target sits among peer trials

58 1135th of 2000 higher than 860 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 NCT00826241, the US trial registry maintained by the National Library of Medicine. NCT00826241 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.