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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2009-06 |
| Est. Completion | 2017-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗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.
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