Phase
Condition
Pancreatic Cancer
Digestive System Neoplasms
Treatment
Bethanechol
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Be willing and able to provide written informed consent for the trial.
Age ≥18 years of age on the day of signing informed consent.
Have histologically or cytologically confirmed the diagnosis of resectablepancreatic ductal adenocarcinoma or be willing to undergo a biopsy with confirmedpathology prior to starting therapy.
Have a predicted life expectancy of greater than 3 months.
Have a performance status of 0 or 1 using the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale within 3 days of the first dose of study drug.
Have a negative urine or serum pregnancy test within 7 days prior to receiving thefirst dose of study medication (Cycle 1, Day 1) (female subjects of childbearingpotential). If the urine test is positive or cannot be confirmed as negative, aserum pregnancy test will be required
Exclusion
Exclusion Criteria:
Has received prior chemotherapy or radiotherapy for a current episode of pancreaticadenocarcinoma.
Is currently using an acetylcholinesterase inhibitor or a beta-blocker.
Has active peptic ulcer disease as defined by documented peptic ulcer and symptomsuncontrolled with oral medication.
Has a known hypersensitivity or allergy to bethanechol.
Has uncontrolled hyperthyroidism, defined as clinical hyperthyroidism uncontrolledby oral medication.
Has bradycardia with resting heart rate < 50 beats per minute.
Has chronic hypotension with resting systolic blood pressure < 90 mmHg.
Has symptomatic coronary artery disease, such as angina or symptoms of claudication
Has vasomotor instability.
Has seizure disorder or required anti-seizure medication for seizure preventionwithin 5 years prior to study entry.
Has a history of Parkinson's disease.
Has bronchial asthma.
Has a history of recent urinary bladder surgery within 12 months of study entry.
Has a history of gastrointestinal resection and anastomosis within 12 months ofstudy entry.
Has a history of current evidence of any condition, therapy, or laboratoryabnormality that might confound the results of the trial, interfere with thesubject's participation for the full duration of the trial, or is not in the bestinterest of the subject to participate, in the opinion of the treating investigator.
Has a known psychiatric or substance abuse disorders that would interfere withcooperation with the requirements of the trial.
Is pregnant or breastfeeding, or expecting to conceive or father children within theprojected duration of the trial, starting with the screening visit through 120 daysafter the last dose of trial treatment.
Study Design
Study Description
Connect with a study center
Columbia University Medical Center
New York, New York 10032
United StatesSite Not Available
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