Trials & Research

VERTU

Trial status: Completed

Last updated: 12 September, 2025

Protocol title

A Randomised Phase II study of Veliparib, Radiotherapy and Temozolomide in patients with unmethylated O (6)-methylguanine-DNA methyltransferase (MGMT) Glioblastoma

Date of activation: 13 May, 2021

Purpose of the study

This Phase II, randomized, open-label trial (VERTU; ACTRN12615000407594) compares standard radiotherapy plus temozolomide against the addition of veliparib in patients with newly diagnosed glioblastoma with unmethylated MGMT promoter. Participants are randomized 2:1 to veliparib plus radiotherapy and adjuvant therapy or standard care. The primary endpoint is 6-month progression-free survival; secondary endpoints include overall survival, toxicity, quality of life, and cognitive function.

Intervention

Control Arm: Radiotherapy (60Gy/30 fractions) for 6 weeks plus concurrent temozolomide daily (75mg/m2) followed 4 weeks later by a 6 month course of adjuvant temozolomide (150-200mg/m2) days 1-5 every 28 days

Experimental Arm: Veliparib capsules 200mg per oral two times per day for 6 weeks with concurrent radiotherapy (60Gy/30 fractions) followed 4 weeks later by a 6 month course of adjuvant temozolomide capsules (150-200mg/m2* per oral days 1-5, every 28 days) given concurrently with veliparib capsules (40mg per oral two times per day).

Study Chair

Professor Mustafa Khasraw and Associate Professor Hao-Wen Sim

Coordinating Centre

NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW, 1450
Australia
Email: vertu.study@sydney.edu.au

Design

Phase II, multi-centre, randomised, open-label,

Cancer Type

Glioblastoma

Publications

  • A randomized phase 2 trial of veliparib (V), radiotherapy (RT) and temozolomide (TMZ) in patients (pts) with unmethylated MGMT (uMGMT) glioblastoma (GBM): Feasibility and safety outcomes (the VERTU study). Mustafa Khasraw, Kerrie Leanne McDonald, Mark Rosenthal, Zarnie Lwin, David M. Ashley, Helen Wheeler, Elizabeth Barnes, Eng-Siew Koh, Matthew C Foote, Michael Buckland, Lauren Fisher, Robyn Leonard, Merryn Hall, Sonia Yip, and John Simes. https://doi.org/10.1200/JCO.2018.36.15_suppl.2045
  • A randomized phase II trial of veliparib (V), radiotherapy (RT) and temozolomide (TMZ) in patients (pts) with unmethylated MGMT (uMGMT) glioblastoma (GBM). Mustafa Khasraw, Kerrie Leanne McDonald, Mark Rosenthal, Zarnie Lwin, David M. Ashley, Helen Wheeler, Elizabeth Barnes, Matthew C. Foote, Eng-Siew Koh, Erik P. Sulman, Michael Back, Michael Buckland, Hao-Wen Sim, Lauren Fisher, Robyn Leonard, Merryn Hall, Sonia Yip, and John Simes. https://doi.org/10.1200/JCO.2019.37.15_suppl.2011
  • Health-related quality of life (HRQL) in VERTU: A randomized phase II trial of veliparib (V), radiotherapy (RT), and temozolomide (TMZ) for newly diagnosed MGMT unmethylated (uMGMT) glioblastoma (GBM). Hao-Wen Sim, Elizabeth Barnes, Zarnie Lwin, Mark Rosenthal, Helen Wheeler, Eng-Siew Koh, Matthew C. Foote, Lauren Fisher, Robyn Leonard, Merryn Hall, John Simes, and Mustafa Khasraw. https://dx.doi.org/10.1200/JCO.2019.37.15_suppl.2042
  • A randomized phase II trial of veliparib, radiotherapy, and temozolomide in patients with unmethylated MGMT glioblastoma: the VERTU study. Hao-Wen Sim , Kerrie L McDonald , Zarnie Lwin , Elizabeth H Barnes , Mark Rosenthal , Matthew C Foote , Eng-Siew Koh , Michael Back , Helen Wheeler , Erik P Sulman, Michael E Buckland , Lauren Fisher , Robyn Leonard , Merryn Hall , David M Ashley , Sonia Yip , John Simes , Mustafa Khasraw.G12
Trials & Research