EGFR-Amplified Newly diagnosed glioblastoma MedDRA version: 20.0 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Depatuxizumab Mafodotin 20mg
Product Code: ABT-414
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: DEPATUXIZUMAB MAFODOTIN
CAS Number: 1585973-65-4
Current Sp
Sponsors
AbbVie Deutschland GmbH & Co.KG
Eligibility
Sex/Gender
All
Inclusion criteria
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 = 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Estimate the percentage of subjects in each prophylactic treatment arm who require a change in Ocular Side Effects (OSE) management due to inadequate control of Ocular Side Effects. ;Secondary Objective: Maximum Change from Baseline on LogMAR Scale;Primary end point(s): The primary endpoint is defined as the percentage of subjects with either a = 3-line decline from baseline (= + 0.3 on LogMAR scale) in visual acuity (with baseline correction), or = Grade 3 Ocular Side Effects severity on the Corneal Epithelial Adverse Event (CEAE) scale, either of which will indicate inadequate control of ocular side effects requiring a change in Ocular side effects management strategy. Unless otherwise noted, visual acuity will be measured using baseline correction, which will be determined at the screening ophthalmology visit and used to assess visual acuity at all remaining ophthalmology visits, for measuring changes in visual acuity and for determining the visual acuity component of the primary endpoint. Details on determining baseline correction are provided in the operations manual. The primary endpoint will be assessed over 8 weeks after initiation of depatuxizumab mafodotin treatment. ;Timepoint(s) of evaluation of this end point: Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The Logarithm of the Minimum Angle of Resolution (LogMAR) scale is the validated tool used in ophthalmology clinical trials to evaluate change in visual acuity.;Timepoint(s) of evaluation of this end point: Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin | — |
Countries
Australia, Denmark, Germany, Netherlands, United Kingdom, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd.
Outcome results
None listed