Phase 3b Study for Management of Ocular Side Effects in Subjects with EGFR-Amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)
- Conditions
- eye disordersGlioblastoma1001591710029211
- Registration Number
- NL-OMON48749
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Trial never started
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 9
• 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;•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.
• 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is defined as the percentage of subjects with either a >=<br /><br>3-line decline from baseline (>= + 0.3 on LogMAR scale) in visual acuity (with<br /><br>baseline correction), or >= Grade 3 OSE severity on the Corneal Epithelial<br /><br>Adverse Event (CEAE) scale, either of which will indicate inadequate control of<br /><br>OSEs requiring a change in OSE management strategy.<br /><br>Unless otherwise noted, visual acuity will be measured using baseline<br /><br>correction, which will be determined at the screening ophthalmology visit and<br /><br>used to assess visual acuity at all remaining ophthalmology visits, for<br /><br>measuring changes in visual acuity and for determining the visual acuity<br /><br>component of the primary endpoint. Details on determining baseline correction<br /><br>are provided in the operations manual.<br /><br>The primary endpoint will be assessed over 8 weeks after initiation of<br /><br>depatuxizumab mafodotin treatment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The Logarithm of the Minimum Angle of Resolution (LogMAR) scale is used to<br /><br>measure visual acuity. The CEAE scale will be used to measure the severity of<br /><br>OSEs. These will be followed over the course of treatment.</p><br>