Management of Depatuxizumab Mafodotin (ABT-414) Ocular Side Effects
Research type
Research Study
Full title
Phase 3b Study for Management of Ocular Side Effects in Subjects with EGFR-Amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)
IRAS ID
243309
Contact name
Paul Sanghera
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2017-003171-64
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 24 days
Research summary
Glioblastoma is the most common and aggressive form of primary brain tumour and survival rates are extremely poor. The standard treatment after surgery is radiotherapy with chemotherapy (temozolomide) given at the same time and then alone following the radiotherapy.
Most people treated with Depatux-M will experience eye side effects, which can be severe and vary from mild irritation to affecting their ability to read or do other activities of daily life. This study will compare different preventative methods and options for treating these side effects.
In this study all patients will receive radiotherapy, temozolomide and Depatux-M.
Patients will be randomly allocated to 1 of 3 groups receiving different eye treatment options. Eye treatment options may include combinations of steroid eye drops/ointment, vasoconstrictor (decrease blood flow to the eye) eye drops and application of a cold compress to the eye. The eye treatment will depend on which group a patient is allocated to.
Patients will attend regular study visits at hospital and have treatment for up to approximately 2 years. They will have regular eye examinations and monitoring of their cancer by a doctor. The study will also involve blood samples and tissue sample collection.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
18/EM/0252
Date of REC Opinion
30 Oct 2018
REC opinion
Further Information Favourable Opinion