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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: Completed Phase 1 study, sponsored by Radiation Therapy Oncology Group.
NCT01062399 is a Phase 1 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 279 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (365% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
DLT is defined as any of the following events occurring during the first 8 weeks of treatment with RAD001 and temozolomide and attributable to the study drugs: any grade 3 or 4 thrombocytopenia, grade 4 anemia, or grade 4 neutropenia lasting more than 7 days; any non-hematologic grade 3 or greater adverse event (AE), excluding alopecia, despite maximal medical therapy; any grade 4 radiation-induced skin changes; failure to recover from adverse events to be eligible for re-treatment with RAD001 a
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 |
What the finished NCT01062399 record still lists
NCT01062399 is an interventional study that assigns participants to a tested intervention. The registered 279 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (365% higher).
The record links to 0 conditions, and to 5 interventions - of which Radiation therapy is the first listed.
NCT01062399 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01062399's enrollment target sits among peer trials
279 146th of 2000 higher than 1,855 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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