Phase
Condition
Adenocarcinoma
Digestive System Neoplasms
Treatment
Pyrvinium Pamoate
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with a diagnosis of pancreatic ductal adenocarcinoma (PDAC) suspectedpreoperatively who are deemed to be surgical candidates by the Thomas JeffersonUniversity surgery department. Patients will be assessed by the pancreatic surgeonsin 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 neoadjuvanttreatment 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 thestudy
Patients must have an estimated life expectancy of > 3 months, and EasternCooperative Oncology Group (ECOG) performance status of 0-1
All patients regardless of age or gender must agree to observe proper contraceptivemethods as to avoid becoming pregnant or causing pregnancy for the duration of thestudy (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 willhave to take a urine human chorionic gonadotropin (HCG) (pregnancy) test priorto enrolling on the study
Exclusion
Exclusion Criteria:
Patients with ongoing anticancer therapies, or those who will have received ananticancer 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 </= 60ml/1.73m^2 fr patients with creatine levels > 1.5 x ULN).
Patients with liver function impairment: Alkaline phosphatase, ALT and AST abovethree 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
Study Design
Study Description
Connect with a study center
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
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