EUCTR2012-003138-17-GB进行中（未招募）1 期
A double-blind, placebo-controlled, randomised, Phase II study evaluating the efficacy and safety of addition of continuous multiple line bevacizumab treatment 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 (1st)-line treatment with radiotherapy, temozolomide and bevacizumab
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
- 296
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
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 confirmation of the diagnosis and pathology.
- •Craniotomy or intracranial biopsy site must be adequately healed. Study treatment should be initiated > 28 days following the last surgical procedure.
- •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 2nd-line 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
- •Treatment with any other investigational drug within 28 days or 2 investigational agent half-lives (whichever is longer) prior to first study treatment
- •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 treatment
- •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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