Study for the Management of Ocular Side Effects in Participants with Epidermal Growth Factor Receptor (EGFR)-amplified GlioblastomaReceiving Depatuxizumab Mafodotin (ABT-414)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

• Participant has a histologically proven, World Health Organization (WHO) grade IV glioblastoma or WHO grade IV gliosarcoma.
• Tumors must demonstrate epidermal growth factor receptor (EGFR) amplification.
• Tumors must be supratentorial in location.
• Participant must have recovered from the effects of surgery, postoperative infection, and other complications; has no significant post-operative hemorrhage.
• Participant has a Karnofsky performance status (KPS) of 70 or higher.
• Participant has adequate bone marrow, renal, and hepatic function.
• Electrocardiogram without evidence of acute cardiac ischemia <= 21 days prior to randomization.
• Participant has a life expectancy of >= 3 months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

• Participants with newly diagnosed Glioblastoma: has received prior chemotherapy or radiotherapy for cancer of the head and neck region; has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment.
• Participant has hypersensitivity to any component of Temozolomide or dacarbazine.
• Participant has received anti-cancer therapy (including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy) prior to 5 years of Study Day 1.
• Participant has clinically significant uncontrolled condition(s) as described in the protocol.
• Participant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.
• Participant has had another active malignancy within the past 3 years except for any cancer considered cured or non-melanoma carcinoma of the skin.
• Participant has a history of herpetic keratitis.
• Participant is not suitable for receiving ocular steroids with conditions as described in the protocol.
• Participant has had laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.
• Participant has a visual condition that compromises the ability to accurately measure visual acuity or assess visual activities of daily living (vADLs).
•Participant has infection with hepatitis B virus (i.e., hepatitis B surface antigen) or hepatitis C virus (i.e., positive for hepatitis C antibody). Subjects who have a history of hepatitis C who have documented cures after anti-viral therapy may be enrolled. Subjects with confirmed positive test result for human immunodeficiency virus (HIV), with CD4
count < 200 cells/microliter are excluded. Note that subjects who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count = 200 cells/microliter within 30 days prior to registration, as the treatments involved in this protocol may be significantly immunosuppressive.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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