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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 is a Phase 3 study that has completed, run by NovoCure. The registered enrollment target is 700 participants.

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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

Sponsor

NovoCure

11 total trials

What the Registry Record Tells You About NCT00916409

The ClinicalTrials.gov registry entry for NCT00916409 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 700 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NovoCure, which has 11 total studies on file at ClinicalTrials.gov.

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

NCT00916409 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.