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

NCT05241249 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: AAAT5285
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreas Cancer

Keywords

Pancreas; pancreatic adenocarcinoma; adenocarcinoma; bethanechol; parasympathetic

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  This rate will be analyzed in patients treated with bethanechol in combination with gemcitabine and nab-paclitaxel compared to historical R0 resection rates.

  36 months

Secondary Outcomes (1)

• Ki-67 expression in tumor cells

  36 months

Study Arms (1)

Bethanechol

EXPERIMENTAL

Patients with borderline resectable pancreatic cancer and no contraindication to bethanechol therapy will receive bethanechol on day 1 and continue until 2 days prior to scheduled surgery for a minimum of 2 months.

Drug: Bethanechol; Drug: Gemcitabine; Drug: nab-paclitaxel

Interventions

Bethanechol DRUG

Study Drug: Bethanechol (generic), supplied as 50mg oral tablets. Subjects will take 2 tablets (100mg) twice daily. Medication should be taken 1 hour before meals in AM and PM. Medication will be purchased commercially and dispensed at the research pharmacy.

Also known as: Bethanechol chloride tablet

Bethanechol

Gemcitabine DRUG

Non-experimental. Chemotherapy will be administered on a day 1, 8 and 15 schedule with gemcitabine at a dose of 1000 mg/m2

Bethanechol

nab-paclitaxel DRUG

Non-experimental. Chemotherapy will be administered on a day 1, 8 and 15 schedule with nab-paclitaxel dose at 125 mg/m2

Bethanechol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Susan E. Bates: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Adenocarcinoma

Interventions

Bethanechol; Gemcitabine; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Bethanechol Compounds; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Onium Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Susan E Bates, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Nurse Navigator

CONTACT

212-342-5162; cancerclinicaltrials@cumc.columbia.edu

Susan E Bates, MD

CONTACT

seb2227@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: This is a Phase IIA study evaluating short term parasympathetic activation with fixed dose bethanechol in subjects with pancreatic cancer who should proceed to surgery after 4 -6 months of chemotherapy.

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 15, 2022
• Study Start: February 1, 2022
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)