Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)
Description
Brief Summary
The objective of this study was to evaluate the effect of several ophthalmologic prophylactic
treatment strategies for the management of ocular side effects (OSEs) in participants with
epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who were being treated
with depatuxizumab mafodotin (ABT-414).
Detailed Description
This Phase 3b open-label, randomized, exploratory study included 2 phases during the
treatment period: chemoradiation therapy (radiation plus temozolomide [RT/TMZ]) and adjuvant
therapy (TMZ). All participants received depatuxizumab mafodotin during both phases of the
treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids;
standard steroids with vasoconstrictors and cold compress; and enhanced steroids with
vasoconstrictors and cold compress. The study comprised a screening period of up to 7 weeks
after surgery, a 6-week concomitant Chemoradiation Phase, an Adjuvant Phase beginning
approximately 4 weeks after completion of chemoradiation, and a Follow-Up Phase.
Phase
N/AInclusion and Exclusion Criteria
- Newly diagnosed glioblastoma (GBM) histologically proven, World Health Organization (WHO) grade IV GBM 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 received prior chemotherapy or radiotherapy for cancer of the head and neck region
- Participant 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) within 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 hepatitis B virus or hepatitis C virus infection
- Participant not receiving treatment with highly active antiretroviral therapy (HAART) when positive for human immunodeficiency virus (HIV)
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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