EUCTR2012-003138-17-AT进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •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
- •Craniotomy or intracranial biopsy site must be adequately healed. Study treatment should be initiated > 28 days following the last surgical
- •Principal eligibility criteria at the time of randomisation (following PD1):
- •Documented disease progression (PD1)
- •Eligibility for 2nd-line treatment with lomustine and bevacizumab as
- •investigational medicinal products.
- •Patients for whom operation or re-operation is indicated before 2ndline
- •starts, tissue submission is mandatory
- •Eastern Cooperative Oncology Group (ECOG) performance status is 0-2
- •when starting 2nd-line treatment
- •Bevacizumab was well tolerated and treatment interruption lasted not
- •more than 60 days
- •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 234
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 66
排除标准
- •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
- •medication or potentially interfering with protocol treatment
- •History or evidence of central nervous system disease unrelated to
- •cancer unless adequately treated with standard medical therapy
- •History or evidence of inherited bleeding diathesis or significant
- •coagulopathy at risk of bleeding
- •Serious non-healing wound, active ulcer, or untreated bone fracture
- •Known hypersensitivity to any component of Avastin/placebo or any of
- •the study drugs
- •Active infection requiring intravenous antibiotics at start of study
- •Other malignancy within 5 years prior to study enrollment, except for
- •carcinoma in situ of the cervix, basal or squamous cell skin cancer,
- •localized prostate cancer or ductal carcinoma in situ treated with
- •curative intent
- •Pregnant or lactating women
- •Participation in any other study
研究者
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