NCT03398655已完成3 期
A Randomized, Controlled, Double-Arm, Double-Blind, Multi-Center Study of Ofranergene Obadenovec (VB-111) Combined With Paclitaxel vs. Paclitaxel Combined With Placebo for the Treatment of Recurrent Platinum-Resistant Ovarian Cancer
Vascular Biogenics Ltd. operating as VBL Therapeutics93 个研究点 分布在 1 个国家目标入组 408 人开始时间: 2017年12月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 408
- 试验地点
- 93
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of this phase 3, randomized, multicenter study is to compare VB-111 and paclitaxel to placebo and paclitaxel in adult patients with Recurrent Platinum-Resistant Ovarian Cancer.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Female patients ≥18 years of age
- •Histologically confirmed epithelial ovarian cancer and documented disease.
- •Patients must have platinum-resistant disease
- •Patients must have disease that is measurable according to RECIST 1.1 and require chemotherapy treatment.
- •Adequate hematological functions:
- •ANC ≥ 1000/mm3
- •PLT ≥ 100,000/mm3
- •PT and PTT (seconds) < 1.2 X ULN. Patients who are anticoagulated do not need to meet criteria for PT and PTT.
- •Patients who are known to carry a BRCA mutation may be enrolled only after (following PARP inhibitor treatment failure, or being intolerant of, or ineligible for PARP inhibitor treatment).
排除标准
- •Non-epithelial tumors (Carcino-sarcomas are excluded)
- •Ovarian tumors with low malignant potential (i.e. borderline tumors) clear cell carcinomas, grade 1 serous tumors or mucinous tumors.
- •History of other clinically active malignancy within 5 years of enrollment, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell carcinoma, adequately controlled, non-metastatic squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast.
- •Previous ovarian cancer treatment with >5 anticancer regimens.
- •Any prior radiotherapy to the pelvis or whole abdomen.
- •Inadequate liver function, defined as serum creatinine > ULN, unless calculated creatinine clearance > 50ml/min (by Cockroft & Gault formula):
- •Serum (total) bilirubin > ULN (Exception: documented Gilbert's disease patients can be enrolled)
- •Alkaline phosphatase, AST/SGOT or ALT/SGPT ≥2.5 x ULN (or ≥ 5 x ULN in the presence of liver metastases).
- •Inadequate renal function, defined as:
- •Serum creatinine > ULN OR
- •Calculated creatinine clearance < 50ml/min (by Cockroft & Gault formula)
- •New York Heart Association (NYHA) Grade II or greater congestive heart failure
- •History of myocardial infarction or unstable angina within 6 months prior to day of randomization.
- •History of stroke or transient ischemic attack within 6 months prior to day of randomization.
- •Patient with proliferative and/or vascular retinopathy
- •Known brain metastases
- •History of hemoptysis or active GI bleeding within 6 month prior to day of randomization
- •Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
- •History of abdominal fistula or gastrointestinal perforation.
- •Current signs and symptoms of bowel obstruction
- •Uncontrolled active infection
- •Patients who had evidence of disease progression during or up to 90 days from the last dose of the first line of platinum based therapy
研究组 & 干预措施
Arm 1
Experimental
VB-111 + Paclitaxel
干预措施: VB-111 + Paclitaxel (Drug)
Arm 2
Active Comparator
Placebo + Paclitaxel
干预措施: Placebo + Paclitaxel (Drug)
结局指标
主要结局
Overall Survival
时间窗: From randomization until death from any cause (up to 5 years after last study treatment)
Progression Free Survival (PFS) by RECIST 1.1
时间窗: From randomization until progression defined according to RECIST 1.1 or death, whichever occurs first (up to 5 years after last study treatment)
次要结局
- Combined CA-125 and RECIST 1.1 response (GCIG)(From date of study entry until the date of death from any cause, or up to 5 years after last study treatment)
- Objective response rate (ORR) by RECIST 1.1(From date of study entry until the date of death from any cause, or up to 5 years after last study treatment)
- OS100 for a sensitivity analysis of OS(From 100 days after date of study entry until the date of death from any cause, or up to 5 years after last study treatment)
- CA-125 Response (GCIG)(From date of study entry until the date of death from any cause, or up to 5 years after last study treatment)
研究者
研究点 (93)
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