ABT-414 alone or ABT-414 plus temozolomide versus lomustine or temozolomide for recurrent glioblastoma: a randomized phase II study of the EORTC Brain Tumor Group.

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 246 人开始时间: 2015年5月19日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•1. Histologically confirmed de novo (primary) GBM with unequivocal tumor progression or recurrence.
•2. In case of testing at the time of first progression: either at least 3 months after the end of radiotherapy or have tumor progression that is clearly outside the radiation field or have tumor progression unequivocally proven by surgery/biopsy
•3. Age = 18 years
•4. Absence of any psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule; such conditions should be assessed with the patient before registration in the trial.
•5. Availability of adequate biological material (formalin-fixed paraffin embedded [FFPE] tumor) for central testing of EGFR amplification
•6. Presence of EGFR amplification confirmed by central assessment; patients with undetermined EGFR status are excluded
•7. WHO Performance status 0 - 2
•8. No more than one line of chemotherapy for GBM (concurrent and adjuvant TMZ based chemotherapy including in combination with another investigational agent is considered one line of chemotherapy). Chemotherapy must have been completed at least 4 weeks prior to randomization.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 6
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 120

•1. Prior treatment with nitrosoureas
•2. Prior treatment with bevacizumab
•3. Previous exposure to EGFR targeted agents, including EGFRvIII targeting agents
•4. Prior discontinuation of temozolomide chemotherapy for toxicity reasons
•5. Prior RT with a dose over 65 Gy to the brain, stereotactic radiosurgery or brachytherapy unless the recurrence is histologically proven
•6. Previous other malignancies, except for any previous malignancy which was treated with curative intent more than 5 years prior to randomization, and except for adequately controlled limited basal cell carcinoma of the skin, squamous carcinoma of the skin or carcinoma in situ of the cervix
•7. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to randomization.

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