Study of Ocular Side Effects in Subjects with Glioblastoma
The main purpose of this study is to improve treatment of ocular (eye) side effects that result from depatuxizumab mafodotin (Depatux-M) use in subjects with glioblastoma (GBM).
In order to participate you must meet the following criteria:
- Have newly diagnosed glioblastoma (GBM) histologically proven, World Health Organization (WHO) grade IV GBM or WHO grade IV gliosarcoma.
- Demonstrate epidermal growth factor receptor (EGFR) amplification.
- Have recovered from the effects of surgery, postoperative infection, and other complications; has no significant post-operative hemorrhage.
You will be excluded from the study if any of the following criteria apply to you:
- Have been newly diagnosed with GBM and have received prior chemotherapy or radiotherapy for cancer of the head and neck region; have received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment.
- Have hypersensitivity to any component of TMZ or dacarbazine.
- Have received anti-cancer therapy (including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy) within 5 years of Study Day 1.
This is a partial list of inclusion and exclusion criteria.