Trial intelligence / Profile preview

Vorinostat with Bevacizumab and Temozolomide for Recurrent Malignant Glioma

NCT00939991Phase 2

Key facts

Status: Completed
Start: Oct 2009
Primary completion: Jan 2012
Countries: 1
Sponsor: Katy Peters
Modality: Covalent Small Molecules, Classical Binding Small Molecules

Drugs: vorinostat
Conditions: malignant gliomaglioblastoma (GBM)

Overview

Phase 2, open-label, single-arm trial of vorinostat in malignant glioma and glioblastoma (GBM), sponsored by Katy Peters. Primary endpoints: Maximum Tolerated Dose and 6-month Progression-free Survival. Started Oct 2009; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Vorinostat + Bevacizumab + Temozolomide
Vorinostat (escalated dose) + Bevacizumab (10 mg/kg q2w) + Temozolomide (50 mg/m2 daily).

Who it enrols

Patients with recurrent malignant glioma (Grade 3/4 for Phase I, Grade 4 for Phase II) who have not progressed on prior Bevacizumab or daily Temozolomide.

Endpoints

Primary

Maximum Tolerated DoseCycle 1 (28 days)
6-month Progression-free Survival6 months

Secondary

Radiographic Response3 years
Median Progression-free Survival3 years
Median Overall Survival3 years
Number of Patients With Grade 2 or Greater, Treatment-related Toxicities3 years

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