A Phase II Study of Tivozanib in Recurrent Glioblastoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Patients Alive and Progression Free After 6 Months
研究概览
简要总结
This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the study drug tivozanib is still being studied. It also means that the FDA has not yet approved tivozanib for your type of cancer.
Tivozanib is an anti-angiogenesis medicine that fights different types of cancer by blocking the blood supply to the tumor, so that the tumor does not receive the nutrients it requires to grow.
In this research study, we are looking to see what effects, good and bad, tivozanib will have on you and your disease.
详细描述
If you are willing to participate in this study, you will be asked to undergo some screening tests and procedures that confirm you are eligible. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out taht you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. The screening process may include the following: a medical history, mini-mental status exam, physical exam, performance status, electrocardiogram, blood tests, urine test. If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study.
If you take part in this research study, you will be given a study drug-dosing calendar for each treatment cycle. Each treatment cycle lasts 28 days (4 weeks) during which time you will be taking the study drug once daily for 3 weeks and then no study drug for the last week of each cycle. The diary will also include special instructions for taking the study drug.
During all cycles you will have a physical exam and you will be asked questions about your general health and specific questions about any problems that you might be having and any medications you may be taking.
Standard contrast-enhanced (CE) MRI scans will be done prior to all odd-numbered study cycles. Vascular MRI scans will be done prior to start of treatment, Day 1 of treatment and prior to all even-numbered cycles. These studies will be done in the Charlestown Navy Yard.
We would like to keep track of your medical condition for up to 24 months after your last dose of study treatment. We would like to do this by calling you on the telephone once a year to see how you are doing. Keeping in touch with you and checking your condition every year helps us look at the long-term effects of the research study.
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 glioblastoma that has progressed based on imaging or surgery
- •Measurable disease
- •No more than 3 prior chemotherapy regimens
- •Must have recovered from toxicity of prior therapy. An interval of at least 3 months must have elapsed since the completion of the most recent course of radiotherapy; at least 3 weeks since last non-nitrosourea containing chemotherapy regimen or molecularly targeted agent; at least 6 weeks since the completion of a nitrosourea containing chemotherapy regimen
- •Life expectancy of at least 12 weeks
- •Able to tolerate MRIs
- •Willing to use adequate, highly effective contraception measures while on study and for at least 45 days after the last dose of study drug
排除标准
- •Pregnant or breastfeeding
- •Major surgical procedure or significant traumatic injury within 28 days of starting therapy; or minor surgical procedure within 7 days
- •Receiving other study agents
- •Prior therapy with an anti-VEGF agent
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to tivozanib
- •Receiving any medications or substances that are inhibitors or inducers of CYP450 enzymes
- •Significant cardiovascular disease
- •Non-healing wound, bone fracture or skin ulcer
- •Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis or other gastrointestinal condition with increased risk of perforation; abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 4 weeks prior to administration of first dose of study drug
- •Uncontrolled intercurrent illness
- •Significant thromboembolic or vascular disorders within 6 months prior to administration of first dose of study drug
- •Significant bleeding disorders within 6 months prior to administration of first dose of study drug
- •Currently active second primary malignancy
- •HIV positive and on combination antiretroviral therapy
- •Inability to swallow capsules, malabsorption syndrome or gastrointestinal disease that severely affects the absorption of study drugs, major resection of the stomach or small bowel, or gastric bypass procedure
研究组 & 干预措施
Tivozanib
1.5 mg daily for 3 weeks, with 1 week off.
干预措施: Tivozanib (Drug)
结局指标
主要结局
Number of Patients Alive and Progression Free After 6 Months
时间窗: 6 months
To determine the number of patients with recurrent glioblastoma (GBM) alive and progression free 6 months (PFR6) after start of tivozanib therapy
次要结局
- Best RANO Criteria Response(2 years)
- Median Progression-Free Survival(From the start of treatment until death or progression, median duration of approximately 2 months)
- Number of Participants With Treatment Related Serious Adverse Events(From the start of treatment until disease progression, unacceptable toxicity, or death; median duration of approximately 2 months)
- Median Overall Survival(From the start of treatment until the time of death, median duration of approximately 8 months)
- Steroid Dosage(2 years)
- Change in Tumor Volume(Baseline, Cycle 1 day 2, pre-cycle 2, pre-cycle 3 (1 cycle= 4 weeks))
- Median Apparent Diffusion Coefficient (ADC)(Baseline, Cycle 1 day 2, pre-cycle 2, pre-cycle 3 (1 cycle= 4 weeks))
- Median Ktrans(Baseline, Cycle 1 day 2, pre-cycle 2, pre-cycle 3 (1 cycle= 4 weeks))
- Relative Oxygen Saturation(Baseline, Cycle 1 day 2, pre-cycle 2, pre-cycle 3 (1 cycle= 4 weeks))
研究者
Elizabeth R. Gerstner, MD
Principal Investigator
Massachusetts General Hospital