NCT01225510撤回2 期
A Phase 2 Trial Of PF-04856884 (CVX-060), A Selective Angiopoietin-2 (Ang-2) Binding CovX-body, In Patients With Recurrent Glioblastoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Progression free survival rate at Month 6 (PFS6) defined as the patient progression free status at Month 6.
研究概览
简要总结
Angiopoietin-2 (Ang-2) is a protein in the body which destabilizes blood vessels and is important in stimulating tumor blood vessels. There is evidence suggesting that Ang-2 may be important for the growth and progression of Glioblastoma multiforme (GBM). PF- 04856884 (CVX-060) is a compound which binds Ang-2 and prevents its activity. The hypothesis is that PF-04856884 will be safe and effective in patients with recurrent Glioblastoma multiforme (GBM).
详细描述
Notification of study being cancelled resulted in update in overall status change from "not yet recruiting" to "withdrawn."
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Tumor eligibility: Primary Cohort: Measurable disease; Exploratory Cohort: Measurable disease as defined above or non-measurable/evaluable disease (eg, progressing non-enhancing lesions).
- •Histologically or cytologically confirmed recurrent GBM in 1st or 2nd relapse: Primary Cohort: Recurrence following radiation therapy and temozolomide, less than or equal to 2 prior chemotherapeutic regimens; Exploratory cohort: Prior radiation therapy, temozolomide, and bevacizumab, Recurrence of disease within 2-4 weeks of last bevacizumab dose.
- •Stable dose of corticosteroids for greater than or equal to 5 days prior to baseline Magnetic Resonance Imaging (MRI)
- •Adequate organ function
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Life expectancy greater than or equal to 12 weeks.
排除标准
- •Patients who have previously received a trial drug containing the core platform antibody (eg, CVX-045, PF-04856884 (CVX-060), CVX-096, PF-05057459 (CVX-241), etc.).
- •History of pathologic fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of therapy.
- •Evidence of bleeding diathesis or coagulopathy.
- •Major surgical procedure (eg, craniotomy), open biopsy, significant traumatic injury within 28 days prior to therapy or anticipation of need for a major surgical procedure during the course of the trial.
- •Minor surgical procedures, fine needle aspiration or core biopsies within 7 days prior to therapy.
- •Serious non-healing wound, ulcer, or bone fracture.
- •Active gastrointestinal bleeding, as evidenced by either hematemesis, hematochezia, or melena in prior 6 months.
- •Hemoptysis >½ teaspoon per day within 1 week of enrollment.
- •National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI CTCAE] Grade 3 hemorrhage from any cause <4 weeks prior to enrollment.
- •Participation in any investigational drug study within 28 days prior to study therapy.
- •Evidence of preexisting uncontrolled hypertension
- •Clinically significant cardiovascular disease within the 12 months prior to starting trial treatment
- •Prolongation of the QT interval corrected [QTc] interval to >450 msec for men or >470 msec for women.
- •History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody or IgG-fusion protein.
- •Exclusion Criteria Specific for Primary Cohort
- •Prior therapy with bevacizumab or other anti-Vascular Endothelial Growth Factor [VEGF] agents for the treatment of GBM.
- •Exclusion Criteria Specific for Exploratory Cohort
- •Patients discontinued from prior bevacizumab or anti-VEGF agents due to toxicity.
- •Patients who have failed 2 prior anti-VEGF therapies.
结局指标
主要结局
Progression free survival rate at Month 6 (PFS6) defined as the patient progression free status at Month 6.
时间窗: 1 year
次要结局
- Corticosteroid doses at baseline and on-study(4 months)
- Overall Response Rate (ORR)(2 years)
- PFS defined as the time from 1st dose of study drug to the 1st documentation of disease progression or death from any cause, whichever comes first.(2 years)
- Time to death is defined as the time from first study drug to death due to any cause.(2 years)
- Overall survival (OS) defined as the time from first dose of study drug to death due to any cause.(2 years)
- OS6 defined as the patient survival status at Month 6. The OS6 rate will be obtained as a Kaplan-Meier estimate of the time to death at Month 6.(2 years)
- Immunogenicity determined by measuring anti-PF-04856884 antibodies following therapy(4 months)
- Dynamic Contrast Enhanced Magnetic Resonance Imaging [DCE-MRI] endpoints to include changes from baseline volume transfer coefficient [Ktrans] and/or the initial area under the contrast agent concentration-time curve [IAUC] or Ki following therapy(4 months)
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