EUCTR2017-003171-64-DE进行中（未招募）1 期
Phase 3b Study for Management of Ocular Side Effects in Subjects with EGFR-Amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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