A double-blind, placebo-controlled, randomised, Phase II study evaluatingthe efficacy and safety of addition of continuous multiple line bevacizumabtreatment to lomustine in second (2nd)-line followed by standard of care(SOC) in third (3rd)-line and beyond compared to addition of placebo,following first progression of disease (PD1) in patients with glioblastoma(GBM) after first - TAMIGA

F. Hoffmann-La Roche Ltd0 个研究点目标入组 300 人2013年4月24日

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注册库

who.int

开始日期

2013年4月24日

结束日期

待定

最后更新

8年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•Are currently enrolled in Study MO28347 and have provided additional consent following amendment 6 to the protocol, which changed the
•study from a Phase IIIb to a Phase II study
•Age \= 18 years .
•Karnofsky performance status (KPS) \= 60\.
•Newly diagnosed, histologically confirmed glioblastoma not previously treated with chemotherypy or radiotherapy
•If female and not postmenopausal (\< 12 months of amenorrhea) or
•surgically sterile, must agree to use a highly effective contraceptive
•method during the treatment period and for at least 6 months after the
•last dose of study drug
•Mandatory tissue collection during pre\-study surgery or biopsy for

•Any prior chemotherapy for GBM and low grade astrocytomas.
•Any prior radiotherapy to the brain or prior radiotherapy resulting in a potential overlap in the radiation field.
•Prior or current anti\-angiogenic treatment (i.e. anti\-VEGF or VEGFR therapies or tyrosine kinase inhibitors).
•Treatment with any other investigational drug within 28 days or 2
•investigational agent half\-lives (whichever is longer) prior to first study
•Inadequate hematological, renal or liver function
•Inadequately controlled hypertension
•Prior history of gastrointestinal perforation or abscess
•Clinically significant cardiovascular disease, NYHA \>/\= Grade II
•congestive heart failure, or serious cardiac arrhythmia uncontrolled by