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drugset / Trial / NCT01933815

Dose-Escalation Study of TPI 287 + Avastin Followed by Randomized Study of the Same Versus Avastin for Glioblastoma

NCT01933815 ↗

Phase 1/2 Suspended 92 enrolled Cortice Biosciences, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is divided into two parts, a dose-escalation study (phase 1) and a randomized study (phase 2). The purpose of the dose-escalation study (phase 1) is to determine the safety, maximum tolerated dose (MTD), and efficacy of TPI 287 in combination with Avastin (bevacizumab) in subjects who have glioblastoma multiforme (GBM) that has progressed following prior radiation therapy and temozolomide (TMZ). The purpose of the randomized study (phase 2) is to determine the safety and efficacy of the phase 1 MTD of TPI 287 in combination with bevacizumab versus bevacizumab alone in subjects who have GBM that has progressed following prior radiation therapy and TMZ.

Timeline

Start
2013-08
Primary completion
2024-11
Completion
2025-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 10 mg/kg Intravenous
Subject TPI 287 Small molecule 140 mg/m2 Intravenous
Subject TPI 287 Small molecule 150 mg/m2 Intravenous
Subject TPI 287 Small molecule 160 mg/m2 Intravenous
Subject TPI 287 Small molecule 170 mg/m2 Intravenous
Subject TPI 287 Small molecule 180 mg/m2 Intravenous
Subject TPI 287 Small molecule 200 mg/m2 Intravenous
Subject TPI 287 Small molecule 220 mg/m2 Intravenous
Subject TPI 287 Small molecule 240 mg/m2 Intravenous

Indications

glioblastoma