drugset / Trial / NCT03119064

BrUOG 329 Onivyde & Metronomic Temozolomide in Recurrent Glioblastoma

NCT03119064

Non-randomizedSequentialOpen-labelTreatment

Summary

New treatments are greatly needed for patients with recurrent glioblastoma. Metronomic temozolomide is a standard treatment option but has, at best, modest activity. The nanoliposomal irinotecan may be much more active than the parent compound irinotecan since nanoliposomal irinotecan's ability to cross the blood brain barrier is improved. This phase I study will establish the MTD of the combination of nanoliposomal irinotecan in combination with temozolomide safety and preliminary clinical efficacy of the combination of nanoliposomal irinotecan and metronomic temozolomide.

Timeline

Start
2017-11-30
Primary completion
2020-04-10
Completion
2021-10-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 50 mg/m2 Intravenous
Subject Irinotecan Small molecule 70 mg/m2 Intravenous
Subject Irinotecan Small molecule 80 mg/m2 Intravenous
Subject Temozolomide Small molecule 50 mg/m2

Indications