drugset / Trial / NCT02052648

Study of IDO Inhibitor and Temozolomide for Adult Patients With Primary Malignant Brain Tumors

NCT02052648

Phase 1/2 Completed 160 enrolled NewLink Genetics Corporation
Non-randomizedParallel-groupOpen-labelTreatment

Summary

In this study, investigators will conduct a phase I/II trial in recurrent (temozolomide resistant) glioma patients. The overall goal of this study is to provide a foundation for future studies with indoximod tested in newly diagnosed glioblastoma patients with radiation and temozolomide, or in combination with vaccine therapies.

Timeline

Start
2014-03
Primary completion
2018-04-18
Completion
2019-06-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 10 mg/kg
Subject Indoximod Small molecule 600 mg Oral
Subject Indoximod Small molecule 1200 mg Oral
Subject Temozolomide Small molecule 150 mg/m2 Oral
Subject Temozolomide Small molecule 200 mg/m2 Oral

Indications