Stimulation With Bethanechol in Combination With Gemcitabine and Nab-paclitaxel in Pancreatic Adenocarcinoma
Recruiting · NCT05241249 · Interventional (participants receive a specific treatment) · Lead sponsor: Susan E. Bates
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- Columbia University Medical Center - New York, New York, United States