A Phase 3, Randomized, Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection (OTL38) for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 11
- 主要终点
- Efficacy Patient Level
研究概览
简要总结
This is a phase 3, randomized, multi-center, single dose, open label, pivotal study in patients diagnosed with, or with high clinical suspicion of, ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery.
详细描述
The Phase 3 study is to confirm the efficacy of OTL38 in combination with fluorescent light to detect additional Folate Receptor-positive (FR+) ovarian cancer lesions not detected by palpation and visualization under normal light in patients with FR+ ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients 18 years of age and older
- •Have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary surgical cytoreduction, interval debulking, or have recurrent ovarian cancer surgery, and:
- •Who are scheduled to undergo laparotomy for the debulking surgery OR
- •Who are scheduled to undergo laparoscopy and pre-authorized to undergo laparotomy for the debulking surgery if cancer is detected on the laparoscopy
- •A negative serum pregnancy test at Screening followed by a negative urine pregnancy test on the day of surgery or day of admission for female patients of childbearing potential
- •Female patients of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion
- •Ability to understand the requirements of the study, provide written informed consent for participation in the study and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments
排除标准
- •Previous exposure to OTL38
- •Known FR-negative ovarian cancer
- •Planned surgical debulking via laparoscopy or robotic surgery, with no intent of laparotomy.
- •Patients with known ovarian cancer miliary disease determined preoperatively to be inoperable.
- •Any medical condition that, in the opinion of the investigators, could potentially jeopardize the safety of the patient
- •History of anaphylactic reactions
- •History of allergy to any of the components of OTL38, including folic acid
- •Pregnancy or positive pregnancy test
- •Clinically significant abnormalities on electrocardiogram (ECG)
- •Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •Impaired renal function defined as eGFR< 50 mL/min/1.73m2
- •Impaired liver function defined as values > 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin.
- •Known Stage IV ovarian cancer with brain metastases
- •Received an investigational agent in another clinical trial within 30 days prior to surgery
- •Known sensitivity to fluorescent light
研究组 & 干预措施
no fluorescent imaging
Patient injected with OTL38, but does not undergo fluorescent imaging
干预措施: OTL38 (Drug)
no fluorescent imaging
Patient injected with OTL38, but does not undergo fluorescent imaging
干预措施: laparotomy (Procedure)
near infrared imaging arm
Patient injected with OTL38 and undergoes near infrared imaging
干预措施: OTL38 (Drug)
near infrared imaging arm
Patient injected with OTL38 and undergoes near infrared imaging
干预措施: near infrared camera imaging system (Device)
near infrared imaging arm
Patient injected with OTL38 and undergoes near infrared imaging
干预措施: laparotomy (Procedure)
结局指标
主要结局
Efficacy Patient Level
时间窗: 30 days
Percentage of patients with at least one evaluable FR+ ovarian cancer lesion confirmed by central pathology (Standard of truth) that was detected using the combination of OTL38 and fluorescent light but not under normal light or palpation (Full Analysis Set)
次要结局
- Patient False Positive Rate(30 days)