NCT01989884已完成2 期
Multicenter, Single Arm, Open-Label Phase II Trial On The Efficacy Of Ortataxel In Recurrent Glioblastoma
Mario Negri Institute for Pharmacological Research7 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 7
- 主要终点
- progression free survival-6
研究概览
简要总结
Italian Study On The Efficacy Of Ortataxel In Recurrent Glioblastoma
详细描述
In this phase II study, adult patients with histologically confirmed GBM in recurrence after surgery or biopsy, standard radiotherapy and chemotherapy with temozolomide were eligible. Patients included were treated with ortataxel 75 mg/m² i.v. every 3 weeks until disease progression. The primary objective of the study was to evaluate the efficacy of ortataxel in terms of progression free survival at six months after the enrolment (PFS-6).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically confirmed GBM.
- •GBM in recurrence/progression after surgery (or biopsy), standard radiotherapy and chemotherapy with Temozolomide.
- •Imaging confirmation of first tumor progression or regrowth as defined by the RANO criteria.
- •No more than one prior line of chemotherapy (Temozolomide).
- •Recovery from the toxic effects of prior therapy.
- •Patients who have undergone recent surgery for recurrent or progressive tumor are eligible provided that:
- •Surgery must have confirmed the recurrence.
- •A minimum of 14 days must have elapsed from the day of surgery to registration. For core or needle biopsy, a minimum of 7 days must have elapsed prior to registration.
- •Craniotomy or intracranial biopsy site must be adequately healed and free of drainage or cellulitis, and the underlying cranioplasty must appear intact at the time of registration.
- •Age ≥ 18 years.
- •Willingness and ability to provide written informed consent and to comply with the study protocol as judged by the investigator.
- •Karnofsky-PS ≥ 60%.
- •Stable or decreasing dose of corticosteroids within 5 days prior to registration.
排除标准
- •Patients unable to undergo brain MRI scans with gadolinium (iv).
- •Pre-existing peripheral neuropathy, grade ≥
- •History of intracranial abscess within 6 months prior to registration.
- •Anticipation of need for major surgical procedure during the course of the trial.
- •Treatment with enzyme inducing antiepileptic agents was not allowed. However, patients whose anticonvulsant was changed to a nonenzymeinducing antiepileptic drug were eligible for entry after a 1-week ''washout'' period
研究组 & 干预措施
Ortataxel
Experimental
75 on day 1 every 21 days mg/m2 milligram(s)/square meter (intravenous use)
干预措施: Ortataxel (Drug)
结局指标
主要结局
progression free survival-6
时间窗: after 6 months after randomization
defined as the percentage of patients who are alive and progression free at 6 months after the randomization
次要结局
- Number of patients with AEs, SAEs, SADRs, SUSARs(after 9 months of follow-up for each patient)
- progression free survival(after 9 months of follow-up for each patient)
- Overall survival-9(9 months after randomization)
- Objective response rate(after 9 months of follow-up for each patient)
- treatment compliance(9 months after randomization)
研究者
研究点 (7)
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