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NCT00916409 · ClinicalTrials.gov registry record · Phase 3

Effect of NovoTTF-100A Together With Temozolomide in Newly Diagnosed Glioblastoma Multiforme (GBM)

A Phase 3 study, sponsored by NovoCure.

Completed
Registry status
Phase 3
Development phase
700
Enrollment target

NCT00916409: Completed Phase 3 study, sponsored by NovoCure.

NCT00916409 is a Phase 3 study that has completed, run by NovoCure. The registered enrollment target is 700 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00916409, a Phase 3 study, has completed, sponsored by NovoCure.

COMPLETED
Registry status
Phase 3
Development phase
700 participants
Enrollment target

Study Summary

The study is a prospective, randomly controlled pivotal trial, designed to test the efficacy and safety of a medical device, the NovoTTF-100A, as an adjuvant to the best standard of care in the treatment of newly diagnosed GBM patients. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

Interventions

  • DRUG Temozolomide
  • DEVICE NovoTTF-100A device

Trial Details

FieldValue
Enrollment Target 700 participants
Start Date 2009-06
Est. Completion 2017-03
Phase Phase 3
NovoCure

11 total trials

What the finished NCT00916409 record still lists

NCT00916409 is an interventional study that assigns participants to a tested intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.

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

NCT00916409 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00916409 about?

NCT00916409 is a clinical study titled "Effect of NovoTTF-100A Together With Temozolomide in Newly Diagnosed Glioblastoma Multiforme (GBM)". The study is a prospective, randomly controlled pivotal trial, designed to test the efficacy and safety of a medical device, the NovoTTF-100A, as an adjuvant to the best standard of care in the treatment of newly diagnosed GBM patients. The device is an experimental, portable, battery operated devic...

What is the current status of trial NCT00916409?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 700 participants. The study started on 2009-06. Estimated completion is 2017-03.

What interventions are being tested in trial NCT00916409?

The interventions under investigation include: Temozolomide (DRUG), NovoTTF-100A device (DEVICE).

Who is sponsoring clinical trial NCT00916409?

This trial is sponsored by NovoCure, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00916409's enrollment target sits among peer trials

700 506th of 2000 higher than 1,485 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00916409, the US trial registry maintained by the National Library of Medicine. NCT00916409 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.