Phase 3b Study for Management of Ocular Side Effects in Subjects with EGFR-Amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)

AbbVie Deutschland GmbH & Co.KG0 sites40 target enrollmentApril 16, 2018

Overview

No summary available.

Registry

who.int

Start Date

April 16, 2018

End Date

March 3, 2020

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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:

•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).