A Phase II study of ABT-414 for recurrent glioblastoma
Research type
Research Study
Full title
ABT-414 alone or ABT-414 plus temozolomide versus lomustine or temozolomide for recurrent glioblastoma: a randomized phase II study of the EORTC Brain Tumour Group
IRAS ID
170496
Contact name
Paul Mulholland
Contact email
Sponsor organisation
AbbVie Ltd.
Eudract number
2014-004438-24
Clinicaltrials.gov Identifier
EORTC protocol reference number, 1410-BTG
Duration of Study in the UK
1 years, 11 months, 26 days
Research summary
Glioblastoma multiforme is the most common and aggressive form of primary brain tumour. Around 2,200 cases are diagnosed each year in England; survival rates are extremely poor. After initial treatment the tumour invariably returns; patients then survive only 6-10 months and there is no uniformly accepted standard of care treatment.
Commonly, patients considered well enough are administered either temozolomide or lomustine chemotherapy. These drugs damage the genetic material of the tumour as it grows. ABT-414 is a new compound which delivers a toxic chemical (monomethylauristatin F) into glioblastoma cells with a marker (“activated” EGFR protein) on the outside. An earlier study has suggested a beneficial effect in patients whose tumours had extra EGFR DNA copies (amplification).
In this study a third of patients will receive chemotherapy only (temozolomide or lomustine tablets), a third will receive ABT-414 infusions with temozolomide, and a third will receive ABT-414 alone. The trial will determine which treatment is better at controlling the cancer, by measuring survival and progression-free time. This is a Phase II, randomised, open label trial (all patients will know which treatments they are receiving).
Patients could benefit if tumour growth is inhibited, improving their condition and survival time. Information gathered may help improve future treatment.
Patients will first have a tumour sample tested for EGFR amplification; if present they may be eligible to join the trial.
They will attend regular study visits at hospital and have treatment for as long as they are benefiting (max one year of lomustine). The effect of treatments on the cancer will be checked by having brain scans, blood tests, checking for side effects and completing questionnaires. There are additional blood tests to see why some people respond better than others, how long the drug remains in the body, and optional genetics tests and research sample donation.
REC name
London - Central Research Ethics Committee
REC reference
15/LO/0615
Date of REC Opinion
1 May 2015
REC opinion
Favourable Opinion