VERTU : A Randomised Phase II study of veliparib and radiotherapy with adjuvant temozolomide and veliparib versus standard radiotherapy and temozolomide followed by temozolomide in patients with newly diagnosed glioblastoma with unmethylated O (6)-methylguanine-DNA methyltransferase

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Multiple<Br/>Treatment TypesTypeMultiple
Treatment Types

TwoPhase Two

Over 18Age Over 18

Brain and Spinal<br/>CancersCancer LocationBrain and Spinal
Cancers

Systemic therapy,Radiotherapy,Multiple treatment types | Brain and spinal cordGlioblastoma (GBM), Glioma

Trial Overview Read MoreRead more

This phase II trial is evaluating the effectiveness of an anti-cancer drug (veliparib), radiotherapy and adjuvant (temozolomide) chemotherapy in patients with newly diagnosed Glioblastoma (GBM).
 

This trial is treating patients with Glioblastoma.

This is a systemic therapy and radiotherapy trial.

You may be able to join this trial if:

  • You have been diagnosed with cancer, but have not received any treatment.

You may be excluded from this trial if:

  • You have had certain treatments, surgical procedures or drugs.
  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Randomised Phase II study of veliparib and radiotherapy with adjuvant temozolomide and veliparib versus standard radiotherapy and temozolomide followed by temozolomide in patients with newly diagnosed glioblastoma with unmethylated O (6)-methylguanine-DNA methyltransferase

Other Non-Commercial Sponsor

Cure Brain Cancer Foundation

Summary

This study aims to evaluate the safety and effectiveness of a combination of veliparib with radiotherapy, followed by a combination of veliparib with temozolomide (a chemotherapy), to treat patients with newly diagnosed glioblastoma multiforme (a type of brain tumour). Who is it for? You can join this study if you are a person who is recently diagnosed with glioblastoma multiforme (brain tumour), underwent surgery (or have been scheduled to undergo surgery) for this diagnosis and are considered for further treatment with radiotherapy plus temozolomide treatment. Study details: If you like to join this study you will first be screened by your specialist to see if you meet the eligibility criteria to participate in this study. If you are deemed eligible to participate you will be randomly (by chance) assigned to one of two possible treatment groups: Group 1 will receive veliparib together with radiotherapy for 6-7 weeks, followed by a 4 week treatment break, which is again followed by a 6 month treatment with a combination of temozolomide and veliparib. Group 2 will receive receive temozolomide together with radiotherapy for 6-7 weeks, followed by a 4 week treatment break, which is again followed by a 6 month treatment with temozolomide. Your chance to receive the group 1 treatment is twice as high as to receive the group 2 treatment. Participants will be asked to attend clinic visits every 2-4 weeks during the treatment period and then two times more (1 month and 3 months after having received the last treatment). During these visits the specialist will assess the status of your glioblastoma and your physical and mental health, and ask you about your well-being. Participants will also be asked to undergo tests and procedures, such as blood testing, urine testing, scans, and questionnaire completion and to give tissue samples for laboratory research.

Recruiting Hospitals Read MoreRead more

Epworth Hospital
Richmond
Ms Felicity Osmond
felicity.osmond@epworth.org.au
03 9936 8055

Barwon Health, University Hospital Geelong
Geelong
Dr Lea-Anne Harrison
leaanne.harrison@barwonhealth.org.au
03 42 15 2758

Monash Medical Centre, Medical Oncology
Clayton
Ms Irina Arzhintar
Irina.Arzhintar@monashhealth.org
03 8572 2018

PCCTU (Parkville cancer clinical trials unit) *
Parkville
Ms Marian Lieschke
marian.lieschke@petermac.org
03 8559 7140