Recruiting
Phase 2

Bethanechol & Gemcitabine, Nab-Paclitaxel

Sponsor:

Susan E. Bates

Code:

NCT05241249

Conditions

Pancreas Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bethanechol

Gemcitabine

nab-paclitaxel

Study Details

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

Study ID

NCT05241249

Start date

Feb 1, 2022

Status verified date

May, 2025

Completion date

Jan, 2026

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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.

Study Design

Enrollment

37 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Bethanechol

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.

Interventions

Bethanechol

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.

Gemcitabine

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

nab-paclitaxel

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

Primary outcome measure

  • R0 resection rate [ Time Frame: 36 months ]

Central Contacts and Locations

Central contacts

Research Nurse Navigator

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

Susan E Bates, MD

seb2227@cumc.columbia.edu

Locations

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Principal Investigator:

Susan E Bates, MD

More Information

Sponsor

Susan E. Bates

Last update posted

Jun 5, 2025

Last verified

May, 2025

Keywords

  • Pancreas
  • pancreatic adenocarcinoma
  • adenocarcinoma
  • bethanechol
  • parasympathetic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Susan E. Bates on 2025-06-05.