Stimulation With Bethanechol in Combination With Gemcitabine and Nab-paclitaxel in Pancreatic Adenocarcinoma
Recruiting
Phase 2
Interventional Study
Pancreas Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 37 (estimated)
- Sponsor
- Susan E. Bates · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
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 …
Contacts