NCT01666600终止1 期
A Phase I/II, Randomized, Open-label, Multi-centre Study of BIBF1120 + Reirradiation (R-RT) Versus Reirradiation in the Treatment of Patients With First or Second Progression of Glioblastoma
Prof. Dr. Wolfgang Wick2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2012年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Maximal tolerated dose of BIBF 1120 in combination with reirradiation (Phase I)
研究概览
简要总结
Patients with glioblastoma at first or second progression who have failed standard treatment that must have included radiochemotherapy with temozolomide and who are a candidate for a reirradiation can be included into the trial. In the phase I part the minimal tolerated dose (MTD)of BIBF 1120 in combination with radiotherapy will be investigated. Subjects in phase II will be randomised to receive reirradiation alone or reirradiation + 2 x MTD BIBF1120.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients with a recurrence / progression of glioblastoma either not being eligible for tumour resection or having macroscopic residual tumour after resection of the recurrence
- •Diagnosis of glioblastoma must be proven histologically and progress must be documented by MRI. MRI images must not be older than 2 weeks before first dosing/start of RT
- •Not more than two prior therapy regimens including one or two resections, one or two chemotherapies (one temozolomide containing concomitant to radiotherapy) and one radiotherapy (RT) for the brain tumour
- •Previous irradiation therapy of the primary tumour with a maximal dose of 60 Gy; at least 8 months since the end of preirradiation
- •Candidate for reirradiation with recurrent tumour visible on MRIT1 (Gd) and with the largest diameter measuring 1 cm to 5 cm
- •Informed consent
- •Age ≥ 18 years, smoking or non-smoking, of any ethnic origin
- •Karnofsky performance index (KPI) ≥ 60%
- •Neutrophile counts > 1500/μl / Platelet counts > 80.000/μl /Haemoglobin > 10 g/dl / Serum creatinine < 1.5-fold upper normal range / Bilirubin, AST or ALT < 2,5-fold upper normal range unless attributed to anticonvulsants / Alkaline phosphatase < 2,5-fold upper normal range
- •Adequate contraception
- •If on steroids, stable or decreasing treatment with steroids within 5 days before treatment start
排除标准
- •More than one RT of brain, prior first radiotherapy with more than 60 Gy
- •Cumulative total dose on the optical chiasm >54 Gy for 2 Gy/fraction, α/β=2
- •Prior treatment with bevacizumab, iodine seeds and/or brachytherapy
- •Unable to undergo MRI
- •Past medical history of diseases with poor prognosis according to the judgement of the Investigator, e.g. severe coronary heart disease, severe diabetes, immune deficiency, residual deficits after stroke, severe mental retardation
- •HIV or hepatitis infection
- •Pregnancy or breast feeding
- •Treatment within any other clinical trial parallel to the treatment phase of the current study or within 30 days before inclusion
- •Known coronary artery disease, significant cardiac arrhythmias or severe congestive heart failure (NYHA class III - IV)
研究组 & 干预措施
BIBF 1120 + reirradiation
Experimental
2 x minimal tolerated dose BIBF 1120 per day in combination with radiotherapy (2 Gy / fraction; 36 Gy in total)
干预措施: BIBF 1120 (Drug)
reirradiation alone
Active Comparator
radiotherapy (2 Gy / fraction; 36 Gy in total)
干预措施: radiotherapy (Radiation)
结局指标
主要结局
Maximal tolerated dose of BIBF 1120 in combination with reirradiation (Phase I)
时间窗: day 0, 8, 15 and 17 post-dose during phase I
次要结局
- Quality of life as determined by EORTC QLQ-C15 PAL and the EORTC brain module QLQ-BN 20(Screening and 6-weekly after radiotherapy)
- Objective response rates (OR)(Time from randomization until response)
- Overall survival(Time from randomization until death)
- Cognitive function determined by MMSE(Screening and 6-weekly after end of radiotherapy)
- Number of participants with adverse events as a measure of safety and tolerability of BIBF1120(Up to 90 days follow-up)
- Progression-free survival(Time from randomization until death or disease progression)
研究者
Prof. Dr. Wolfgang Wick
Professor Dr. med.
University Hospital Heidelberg
研究点 (2)
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