CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 86 enrolled
Drug / intervention
everolimus +1 moredrug
Likely dose
everolimus 5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01434602
NCT01434602Phase 2Completed
CompareCT.gov

A Phase I-II Trial of Everolimus and Sorafenib in Patients With Recurrent High-Grade Gliomas

National Cancer Institute (NCI)·interventional·Posted Sep 15, 2011·Updated Jun 1, 2022

In Brief

A Phase 2 clinical trial evaluating everolimus and sorafenib for Brain Tumor and 2 related conditions. Completed, enrolled 86 participants across 1 site.

Detailed Summary

The goal of Phase 1 of this clinical research study is to find the highest tolerable dose and best schedule of the combination of everolimus and sorafenib that can be given to patients with malignant glioma. The goal of Phase 2 of this study to learn if the combination of everolimus and sorafenib can help to control malignant glioma. The safety of this combination will also be studied in both phases.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Tumor, Glioblastoma, Anaplastic Glioma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 15, 2011
Enrollment StartOct 2, 2012
Primary CompletionOct 19, 2020
Study CompletionJul 13, 2021
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 14.8 years ago

Interventions

everolimusdrug

Patients will be treated with daily everolimus (days 1-28) in combination with sorafenib; There is not a defined set maximum number of cycles that a patient may have; Phase I Dose Escalation: 5mg to 10mg daily.

sorafenibdrug

Patients will be treated with sorafenib in combination with everolimus (days 1-28); There is not a defined set maximum number of cycles that a patient may have; Phase I Dose Escalation 400mg-600mg twice a day (bid) or 400mg-800mg twice a day, 7 days on and 7 days off.