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Stimulation With Bethanechol in Combination With Gemcitabine and Nab-paclitaxel in Pancreatic Adenocarcinoma

RECRUITINGPhase 2Sponsored by Susan E. Bates
Actively Recruiting
PhasePhase 2
SponsorSusan E. Bates
Started2022-02-01
Est. completion2026-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT05241249

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions2

CancerPancreas Cancer

Locations1 site

Columbia University Medical Center
New York, New York, 10032
Susan E Bates, MD

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