NCT05055323进行中（未招募）1 期
A Phase I Dose Escalation Study Using Pyrvinium Pamoate Targeting HuR in Pancreatic Ductal Adenocarcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Incidence of dose limited toxicity (DLT)
研究概览
简要总结
This phase I trial studies the side effects and best dose of pyrvinium pamoate for the treatment of pancreatic ductal adenocarcinoma that cannot be removed by surgery (resectable). Pyrvinium pamoate may slow down tumor growth and help patients live longer.
详细描述
PRIMARY OBJECTIVE:
I. To determine the safety and tolerability of pyrvinium pamoate (PP), dosed orally, in patients with pancreatic ductal adenocarcinoma (PDAC) that are surgical candidates.
SECONDARY OBJECTIVE:
I. Assessment of PP's pharmacokinetic and pharmacodynamic (PK/PD) profile and bioavailability in humans.
OUTLINE: This is a dose-escalation study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of pancreatic ductal adenocarcinoma (PDAC) suspected preoperatively who are deemed to be surgical candidates by the Thomas Jefferson University surgery department. Patients will be assessed by the pancreatic surgeons in the pancreatic surgery clinic, and if they are found to have resectable disease, they can be considered for this study
- •Patients must not be on neoadjuvant therapy, or have received their last neoadjuvant treatment greater than or equal to within three weeks of starting PP therapy
- •Provide signed and dated informed consent form
- •Willing to comply with all study procedures and be available for the duration of the study
- •Patients must have an estimated life expectancy of > 3 months, and Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •All patients regardless of age or gender must agree to observe proper contraceptive methods as to avoid becoming pregnant or causing pregnancy for the duration of the study (30 days after last dose of drug)
- •Males will practice safe sex methods (i.e. condoms)
- •Women of child bearing potential will practice safe sex methods (i.e. condoms, birth control), if a female on the study is of child-bearing age, they will have to take a urine human chorionic gonadotropin (HCG) (pregnancy) test prior to enrolling on the study
排除标准
- •* Patients with ongoing anticancer therapies, or those who will have received an anticancer therapeutic \<3 weeks prior to the first dose of PP
- •* Any condition that precludes pancreatic surgical resection at the time of the study
- •* Pregnancy or currently breastfeeding
- •* Known allergic reactions to components of the study product(s): pyrvinium pamoate/ pyrvinium embonate (Molevac)
- •* Patients with chronic bowel conditions (such as inflammatory bowel disease (IBD))
- •* Kidney function impairment (serum creatine \> 1.5 x ULN or creatine clearance \ 1.5 x ULN).
- •* Patients with liver function impairment: Alkaline phosphatase, ALT and AST above three folds the normal limit (see normal ranges); Total Bilirubin level \> 3mg/dl; Albumin \< 3g/dl
- •\* Alkaline phosphatase:
- •* 0-9 years (yr): 83-280 IU/L at 37 degrees Celsius
- •* 10-14 yr: 91-400
- •* 15-17 yr: 37-240
- •* 18-49 yr: 29-92
- •* 50-74 yr: 25-120
- •* 75-97 yr: 29-160
- •* 98-99 yr: 29-120
- •* \> 99 yr: 29-160
- •* Patients with liver function impairment outside of the below ranges
- •\* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]):
- •\*\* Male (M): 1-45 IU/L at 37 degrees Celsius
- •\*\* Female (F): 1-30
- •* Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]):
- •* M: 7-42 IU/L at 37 degrees Celsius
- •* F: 7-35
- •* Patients with liver function impairment outside of the below ranges
- •\* Albumin:
- •* 0-1 yr: 2.6-4.4
- •* 1-15 yr: 3.0-4.7
- •* 16-99 yr: 3.2-4.9
- •* Patients with liver function impairment outside of the below ranges
- •\* Bilirubin, total:
- •\*\* 0.1-0.9 mg/dL
- •* Patients with liver function impairment outside of the below ranges \* Protein, total:
- •* 0-1 yr: 4.6-7.2 g/dL
- •* 1-15 yr: 5.7-8.2
- •* 16-99 yr: 6.0-8.5
研究组 & 干预措施
Treatment (pyrvinium pamoate)
Experimental
Patients receive pyrvinium pamoate PO QD for 3 days in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery.
干预措施: Pyrvinium Pamoate (Drug)
结局指标
主要结局
Incidence of dose limited toxicity (DLT)
时间窗: Up to 30 days from last dose
Considered any grade 3 or higher adverse event due to the drug itself or delay of surgery. Research coordinator will call patient every day to monitor for DLTs.
次要结局
- Bioavailability of PP(Up to 4 weeks)
- Profile of pyrvinium pamoate (PP)(Completion of treatment)
- Fatty tissue accumulation of PP(Up to 4 weeks)
- Profile of pyrvinium pamoate (PP)(At Start of Treatment)
研究者
研究点 (2)
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