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NCT01062399 · ClinicalTrials.gov registry record · Phase 1
Everolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
A Phase 1 study, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 279
- Enrollment target
NCT01062399 is a Phase 1 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 279 participants.
The verdict
NCT01062399, a Phase 1 study, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 279 participants
- Enrollment target
Study Summary
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Giving everolimus together with temozolomide and radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when given together with temozolomide and radiation therapy and to see how well it works in treating patients with newly diagnosed glioblastoma multiforme.
Interventions
- RADIATION Radiation therapy
- DRUG concurrent RAD001 10 mg/day
- DRUG concurrent temozolomide
- DRUG concurrent RAD001 2.5 mg/day
- DRUG concurrent RAD001 5 mg/day
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 279 participants |
| Start Date | 2010-12 |
| Est. Completion | 2022-05-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01062399
The ClinicalTrials.gov registry entry for NCT01062399 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 279 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Radiation Therapy Oncology Group, which has 144 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Radiation therapy is the first listed.
NCT01062399 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01062399 about?
NCT01062399 is a clinical study titled "Everolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme". RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopp...
What is the current status of trial NCT01062399?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 279 participants. The study started on 2010-12. Estimated completion is 2022-05-20.
What interventions are being tested in trial NCT01062399?
The interventions under investigation include: Radiation therapy (RADIATION), concurrent RAD001 10 mg/day (DRUG), concurrent temozolomide (DRUG), concurrent RAD001 2.5 mg/day (DRUG), concurrent RAD001 5 mg/day (DRUG).
Who is sponsoring clinical trial NCT01062399?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
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