drugset / Trial / NCT01434602

Phase I-II Everolimus and Sorafenib in Recurrent High-Grade Gliomas

NCT01434602

Phase 1/2 Completed 86 enrolled National Cancer Institute (NCI)
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2012-10-02
Primary completion
2020-10-19
Completion
2021-07-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule 5 mg Oral
Subject Everolimus Small molecule 10 mg Oral
Subject Sorafenib Small molecule 400 mg Oral
Subject Sorafenib Small molecule 600 mg Oral
Subject Sorafenib Small molecule 800 mg Oral