NCT01711970已完成1 期
A Phase I/II Trial of Multiple Dose VB-111 and Weekly Paclitaxel for the Treatment of Recurrent Platinum-Resistant Müllerian Cancer
Vascular Biogenics Ltd. operating as VBL Therapeutics1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2012年11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
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Define toxicities
研究概览
简要总结
This is a prospective, open label, dose escalating, Phase I/II study, measuring mainly the safety and tolerability of the combination of intravenous administration of VB-111 and paclitaxel in patients with platinum resistant ovarian cancer.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged > 18
- •Histologically confirmed epithelial ovarian, peritoneal, or fallopian tube cancer, and uterine papillary serous carcinomas (UPSC), and gynecologic malignant mixed müllerian tumors (MMMTs).
- •Must have had prior platinum or platinum based therapy.
- •Eastern Cooperative Oncology Group (ECOG) status 0-
- •Platinum resistant or refractory disease within 6 months of completing or while receiving a platinum and taxane containing regimen
- •Measurable disease
- •Adequate bone marrow and hematological function.
- •Must have recovered from acute toxicity from prior treatment
- •Prior treatment with an anti-angiogenic agent is not an exclusion criterion.
- •No prior GI perforation, or GI obstruction or involvement of the bowel on imaging
- •Known hypersensitivity to Cremophor EL. However, participants are eligible if they have had a prior paclitaxel reaction, but subsequently tolerated the drug at rechallenge.
- •No patients receiving other investigational therapy for the past 30 days before dosing.
排除标准
- •More than 3 prior lines of chemotherapy for recurrent cancer.
- •History of other active malignancy, other than superficial basal cell and superficial squamous cell, or carcinoma in situ of the cervix within last 2 years.
- •Life expectancy of less than 3 months
- •CTC Grade 1 or greater neuropathy (motor or sensory) from comorbidity other than prior taxane exposure, such as diabetes.
- •Inadequately controlled hypertension or prior history of hypertensive crisis or hypertensive encephalopathy.
- •New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- •History of myocardial infarction or unstable angina within 6 months prior to study Day
- •History of stroke or transient ischemic attack within 6 months prior to Day
- •Known CNS disease, except for treated brain metastasis
- •Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day
- •History of hemoptysis (1/2 teaspoon of bright red blood per episode) within 1 month prior to Day
- •Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
研究组 & 干预措施
VB-111
Experimental
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Define toxicities
时间窗: 2 years
Define toxicities of a limited number of doses of combination VB-111 and weekly paclitaxel spanning anticipated effective doses.
次要结局
未报告次要终点
研究者
研究点 (1)
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