NCT04843319终止1 期
Open-Label, Proof-of-Concept and Dose Finding Phase 1b/2 Study of VERU-100 in Men With Advanced Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Veru Inc.
- 入组人数
- 24
- 试验地点
- 11
- 主要终点
- Percent of men with total testosterone at <50 ng/dL by day 28
研究概览
简要总结
To determine an effective dose of VERU-100 for the treatment of advanced prostate cancer by assessing its effect on testosterone levels by Day 28 and maintenance through Day 91.
详细描述
This study is a multicenter, randomized, open-label, dose finding study of VERU-100 to attain and maintain serum total testosterone levels within castrate range (<50ng/dL) in men with advanced prostate cancer. Stage 1 of the study will assess the effect of VERU-100 at various doses. Stage 2 will further assess the efficacy of the effective doses of VERU-100 in an expanded patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Be over 18 years of age
- •Be able to communicate effectively with the study personnel
- •Have histologically confirmed prostate cancer
- •Have prostate cancer staged T3-4NxMx or TxN1Mx or TxNxM1 according to the TNM classification or the patient should have rising PSA after failed local therapy and be candidate for androgen deprivation therapy
- •Have a QTc interval <440 ms
- •Subjects are judged by the attending physician and/or Principal Investigator to be a candidate for androgen deprivation therapy (continuous therapy)
- •ECOG performance status of 0 to 2
- •Baseline morning serum testosterone levels >150 ng/dL at Screening Visit
- •Have a life expectancy of ≥18 months
- •Subjects must agree to use acceptable methods of contraception
- •If their female partners are pregnant or lactating, acceptable methods of contraception from the time of the first administration of study medication until 6months following administration of the last dose of study medication must be used. Acceptable methods are: Condom used with spermicidal foam/gel/film/cream/suppository. If the subject has undergone surgical sterilization (vasectomy with documentation of azoospermia),a condom with spermicidal foam/gel/film/cream/suppository should be used.
- •If the male subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6 months following administration of the last dose of study medication. Acceptable methods of contraception are as follows: Condom with spermicidal foam/gel/cream/suppository [i.e.,barrier method of contraception], surgical sterilization (vasectomy with documentation of azoospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom used with spermicidal foam/gel/film/cream/suppository).
- •If the female partner has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) should also be used.
- •If the female partner has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS),a barrier method (condom with spermicidal foam/gel/film/cream/suppository) should also be used.
- •Laboratory values within the following ranges: hemoglobin ≥10 gm/dL, total bilirubin
- •1.5x upper limit of normal (ULN), AST ≤2.5x ULN, ALT ≤2.5x ULN,
- •1.5 mg/dL, absolute neutrophil count ≥1500 cell/uL and platelets ≥100,000 cells/uL.
- •Creatinine clearance ≥60 mL/min based on Cockcroft-Gault equation.
- •Subject is willing to comply with the requirements of the protocol through the end of the study
排除标准
- •Prior androgen deprivation therapy within 6 months prior to Screening Visit.
- •Potentially curable disease receiving ADT for localized disease
- •History of bilateral orchiectomy, adrenalectomy, or hypophysectomy
- •Received chemotherapy, cryotherapy, or antiandrogen therapy within 8 weeks prior to the Screening visit for the treatment of prostate cancer.
- •Known hypersensitivity to cetrorelix or other LHRH antagonists
- •History of Torsade de Pointes
- •Currently taking QT-prolonging drugs
- •Any disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, endocrine, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk
- •Use of exogenous testosterone within 6 months of Screening Visit
- •Use of 5α-reductase inhibitor within 3 months of Screening Visit
- •Use of systemic corticosteroids at a dose >10 mg/day at Screening
- •Major surgery within 4 weeks of Screening Visit (including surgery for prostate cancer)
- •Uncontrolled symptomatic congestive heart failure (NYHA Class III -IV), unstable angina pectoris, cardiac arrhythmia, or uncontrolled atrial fibrillation
- •History of diabetes mellitus Type
- •Uncontrolled diabetes mellitus Type 2 (control with oral hypoglycemic agents are allowed)
- •Received an investigational drug within a period of 90days prior to enrollment in the study
- •Received the study medication (VERU-100) previously
- •Have been previously diagnosed or treated for active cancer(other than prostate cancer or non-melanoma skin cancer) within the previous five years
研究组 & 干预措施
VERU-100 at various doses
Experimental
2 ml, 2.5 ml, 3 ml, 3.5 ml of VERU-100
干预措施: VERU-100 (Drug)
结局指标
主要结局
Percent of men with total testosterone at <50 ng/dL by day 28
时间窗: Day 28
Percent of men that reach castrate level (\<50 ng/dL) of total testosterone levels by Day 28
次要结局
- Total testosterone below 20ng/dL levels on VERU-100(Day 28 and Day 91)
研究者
研究点 (11)
Loading locations...
相似试验
已完成
1 期
A Drug-Drug Interaction Study of Carbamazepine and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-012)HealthyNCT06633419Merck Sharp & Dohme LLC14
已完成
1 期
A Drug-Drug Interaction Study of Diltiazem and MK-5684 in Healthy Adult Male Participants (MK-5684-011)Prostatic NeoplasmsNCT06554639Merck Sharp & Dohme LLC12
终止
1 期
VAccination in Early and ADvanced Prostate caNCErIntermediate Risk Prostate CancerCastration-resistant Prostate CancerNCT03815942University of Oxford23
已完成
1 期
Dose-finding, Pharmacokinetics, and Safety of VABOMERE in Pediatric Subjects With Bacterial InfectionsBacterial InfectionsNCT02687906Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)39
已完成
1 期
A Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic LymphomaAcute Lymphoblastic Leukemia (ALL)Lymphoblastic LymphomaNCT03181126AbbVie69