Phase II, Neoadjuvant Study of Parasympathetic Stimulation With Bethanechol in Combination With Gemcitabine and Nab-paclitaxel in Borderline Resectable Pancreatic Adenocarcinoma

Trial ID: NCT05241249

Interventional - Phase 2 - Recruiting

The primary objective of this study is to assess the impact of bethanechol therapy on R0 resection rates. The safety objective will be assessment of the safety and tolerability of bethanechol in combination with gemcitabine and nab-paclitaxel. The exploratory objective will be to evaluate genomic biomarkers associated with parasympathetic stimulation in pancreatic cancer, and the ability to reduce tumor growth rate.

Conditions

• Pancreas Cancer

Interventions

• Bethanechol
• Gemcitabine
• nab-paclitaxel

Eligibility

Inclusion criteria

• Pancreatic Ductal Adenocarcinoma
• Plan for neoadjuvant chemotherapy
• Available diagnostic tissue adequate for biomarker analysis
• Ability to tolerate PO meds and comply with study procedures

Exclusion criteria

• Metastatic disease
• Evidence of GI obstruction
• Baseline bradycardia (HR\<55) or hypotension (systolic blood pressure\<90)
• Use of acetylcholinesterase inhibitors
• Medical conditions including: hyperthyroidism, active/symptomatic coronary artery disease, seizure disorder, peptic ulcer disease.

Sponsor

Susan E. Bates

Source: ClinicalTrials.gov

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