NL-OMON49366已完成不适用
A phase 1a/1b/2 study to assess the safety, tolerability and pharmacokinetics of OTL78, a PSMA-targeted fluorescent agent, for the intraoperative imaging of prostate cancer - Study for intraoperative imaging of prostate cancer using OTL78
OnTarget Laboratories0 个研究点目标入组 39 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Healthy volunteers (part A)
- •1) Male and 18-65 years old at screening.
- •2) Able and willing to comply with study procedures, with signed and dated
- •informed consent obtained before any study-related procedures are performed.
- •3) Agree to use an effective method of contraception for 90 days after
- •administration.
- •4) A body mass index is *30 kg/m2.
- •5) The subject is healthy with no acute or chronic medical illnesses, has a
- •normal physical examination, and normal vital signs findings at screening.
- •6) The subject*s screening 12-lead ECG and clinical laboratory test results are
- •within normal limits, or if any are outside of normal limits they are
- •considered clinically insignificant at the discretion of the investigator.
- •7) Negative screening test results for hepatitis B, hepatitis C, and human
- •immunodeficiency virus.
- •8) Negative test results for drug and alcohol screening.
- •9) Absence of any psychological, familial, sociological or geographical
- •condition that at the discretion of the investigator could potentially hamper
- •compliance with the study protocol and follow-up schedule; such conditions
- •should be discussed with the patient during the prescreening period.
- •Patients (part B)
- •1) Male patients > 18 years of age and older at screening.
- •2) Able and willing to comply with study procedures, and signed and dated
- •informed consent obtained before any study-related procedures are performed.
- •3) Known or high clinical suspicion of (primary or recurrent) prostate cancer
- •scheduled to undergo a pelvic lymph node dissection for salvage or staging at
- •4) The 12-lead ECG and clinical laboratory test results are within normal
- •limits, or if any are outside of normal limits they are considered clinically
- •insignificant at the discretion of the investigator
- •5) Chronic or acute medical illness that in the discretion of the investigator
- •may confound or complicate the findings in this study
- •6) Patients are clinically fit for surgery
- •7) Agree to use an effective method of contraception for 90 days after
- •administration
- •8) Absence of psychological familial, sociological or geographical condition
- •that at the discretion of the investigator could potentially hamper compliance
- •with the study protocol and follow- up schedule; such conditions should be
- •discussed with the patient during the prescreening period.
- •Patients (part C)
- •1) Male patients > 18 years of age and older at screening.
- •2) Able and willing to comply with study procedures, and signed and dated
- •informed consent obtained before any study-related procedures are performed.
- •3) Known or high clinical suspicion of prostate cancer (Gleason score 7+)
- •planned for a prostatectomy at the NKI.
- •4) The 12-lead ECG and clinical laboratory test results are within normal
- •limits, or if any are outside of normal limits they are considered clinically
- •insignificant at the discretion of the investigator
- •5) Chronic or acute medical illness that in the discretion of the investigator
- •may confound or complicate the findings in this study
- •Protocol Version 1.5 / 17-Jan-2020 Page 22 of 68
- •6) Patients are clinically fit for surgery
- 另有 4 项未显示
排除标准
- •Healthy volunteers (part A)
- •1) Female subjects
- •2) Known acute or chronic disease, abnormal physical examination or blood tests
- •of clinical significance.
- •3) The subject has previously been included in an OTL study.
- •4) Use of prescription drugs within 30 days of screening and during study
- •participation
- •5) Participation in a clinical trial within 90 days of screening or more than 4
- •times in the previous year.
- •6) History of clinically significant allergies or anaphylactic reactions.
- •7) History of allergy to any of the components of OTL78 or excipients (see
- •Investigator*s Brochure).
- •Patients (part B)
- •1) Any condition that in the opinion of the investigators could potentially
- •jeopardize the health status of the patient
- •2) History of clinically significant allergies or anaphylactic reactions
- •3) History of allergy to any of the components of OTL78 or excipients (see
- •Investigator*s Brochure)
- •4) Impaired renal function defined as eGFR<50 ml/min/1.73m2
- •5) Impaired liver function defined as values greater than 3x the upper limit of
- •normal (ULN) for ALT, AST, or 2x the upper limit of normal for total bilirubin
- •(excl. Gilbert*s syndrome)
- •6) Previous participation in an OTL study
- •Patients (part C)
- •1) Any condition that in the opinion of the investigators could potentially
- •jeopardize the health status of the patient
- •2) History of clinically significant allergies or anaphylactic reactions
- •3) History of allergy to any of the components of OTL78 or excipients (see
- •Investigator*s Brochure)
- •4) Impaired renal function defined as eGFR<50 ml/min/1.73m2
- •5) Impaired liver function defined as values greater than 3x the upper limit of
- •normal (ULN) for ALT, AST, or 2x the upper limit of normal for total bilirubin
- •(excl. Gilbert*s syndrome)
- •6) Previous participation in an OTL study
研究者
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