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Anti-metabolite

Bethanechol + Chemotherapy for Pancreatic Cancer

Phase 2
Recruiting
Led By Susan E Bates, MD
Research Sponsored by Susan E. Bates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Plan for neoadjuvant chemotherapy
Pancreatic Ductal Adenocarcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trial is testing a drug to see if it increases the chances of a successful surgery to remove a pancreatic tumor, as well as if it is safe and well tolerated.

Who is the study for?
This trial is for individuals with Pancreatic Ductal Adenocarcinoma who are planning to undergo neoadjuvant chemotherapy. They must have tissue available for biomarker analysis and be able to take oral medications. People with metastatic disease, GI obstruction, very low heart rate or blood pressure, or certain medical conditions like hyperthyroidism cannot participate.Check my eligibility
What is being tested?
The study tests the effect of bethanechol combined with gemcitabine and nab-paclitaxel on pancreatic cancer surgery success rates (R0 resection). It also looks at safety and explores how this treatment might affect tumor growth and genomic markers related to parasympathetic stimulation.See study design
What are the potential side effects?
Potential side effects may include digestive issues due to bethanechol's action on the gut, as well as common chemotherapy-related side effects such as fatigue, nausea, hair loss, lowered blood cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for chemotherapy before surgery.
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I have been diagnosed with pancreatic cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
R0 resection rate
Secondary outcome measures
Ki-67 expression in tumor cells

Trial Design

1Treatment groups
Experimental Treatment
Group I: BethanecholExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bethanechol
FDA approved
Gemcitabine
FDA approved
Paclitaxel
FDA approved

Find a Location

Who is running the clinical trial?

Susan E. BatesLead Sponsor
Susan E Bates, MDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
18 Total Patients Enrolled

Media Library

Gemcitabine (Anti-metabolite) Clinical Trial Eligibility Overview. Trial Name: NCT05241249 — Phase 2
Pancreatic Cancer Research Study Groups: Bethanechol
Pancreatic Cancer Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT05241249 — Phase 2
Gemcitabine (Anti-metabolite) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05241249 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the projected enrollment for this trial?

"Affirmative. According to details available on clinicaltrials.gov, this trial began recruiting patients as of February 1st 2022 and has been modified since then. Currently, the study requires 37 individuals across a single site to partake in it."

Answered by AI

Is enrollment for this study still available?

"As per the clinicaltrials.gov registry, this medical trial is actively searching for participants. It was first published on February 1st 2022 and later updated on March 2nd of the same year."

Answered by AI

Has the FDA officially sanctioned Bethanechol for public consumption?

"Due to the lack of efficacy-related data, our analysts assigned bethanechol a safety rating of 2 out of 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Stimulation With Bethanechol in Combination With Gemcitabine and Nab-paclitaxel in Pancreatic Adenocarcinoma
Susan E. Bates 2022. "Stimulation With Bethanechol in Combination With Gemcitabine and Nab-paclitaxel in Pancreatic Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05241249.
~8 spots leftby Jan 2025
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