Study to Evaluate Ibudilast and TMZ Combo Treatment in Newly Diagnosed and Recurrent Glioblastoma

Summary

Participation Requirements

Description

This is a multi-center open-label, dose escalation study to evaluate the safety, tolerability and efficacy of MN-166 (ibudilast) and Temozolomide combination treatment in patients with newly diagnosed or recurrent glioblastomas. To be eligible, subjects are histologically confirmed GBM (glioblastoma...

This is a multi-center open-label, dose escalation study to evaluate the safety, tolerability and efficacy of MN-166 (ibudilast) and Temozolomide combination treatment in patients with newly diagnosed or recurrent glioblastomas. To be eligible, subjects are histologically confirmed GBM (glioblastoma) or gliosarcoma, or astrocytomas with molecular features of GBM, WHO Grade 4. Recurrent GBM patients must have a Karnofsky Performance Status (KPS) ?70 or Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Newly diagnosed glioblastoma GBM, gliosarcoma, or astrocytomas with molecular features of GBM must have a KPS ?60 and ECOG score 0-1. This is divided into a dose-escalation phase (Part 1) followed by a fixed-dose phase (Part 2). Part 1 will evaluate the safety and tolerability of MN-166 (ibudilast) when given in combination with TMZ, and determine the dose of MN-166 (ibudilast) to be used in Part 2 of the study. Up to 18 adult subjects are planned to be enrolled in Part 1. Part 2 will evaluate the efficacy of MN-166 (ibudilast) and temozolomide combination treatment as measured by the proportion of subjects who are progression-free at 6 months. Other outcome measures include the evaluation of overall survival, response rate, and median six-month progression-free survival and up to 32 subjects are planned to be enrolled in Part 2.

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