John Lenehan
John Lenehan
To confirm the safety of combining oral fecal microbiota transplantation (FMT) with gemcitabine and nab-paclitaxel chemotherapy as first line treatment in patients with unresectable or metastatic pancreatic ductal adenocarcinoma.
Unresectable or Metastatic Advanced Pancreatic Ductal Adenocarcinoma
Fecal Microbiota Transplantation
PEG3350
Gemcitabine
nab-Paclitaxel
Phase 1
This is a phase 1 open-labelled, non-randomized safety trial examining oral fecal microbiota transplantation (FMT) with healthy donor stool in combination with standard of care (SOC) gemcitabine and nab-paclitaxel (GnP) in patients with advanced (unresectable and metastatic) pancreatic ductal adenocarcinoma (PDAC) as first-line therapy. A total of 20 eligible patients will be treated with study treatment. The purpose of the trial is to confirm the safety of combined therapy, assess clinical outcomes, perform gut microbiome analysis, systemic immune profiling, and explore patient-related outcomes. This trial will be conducted at the Verspeeten Family Cancer Centre (formerly known as the London Regional Cancer Program) at London Health Sciences Centre.
Study Type : | Interventional |
Estimated Enrollment : | 20 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | An Open-label, Single-arm, Phase 1 Study of the Combination of FMT and Gemcitabine With Nab-paclitaxel as First-line Therapy in Patients With Advanced Pancreatic Ductal Adenocarcinoma. |
Actual Study Start Date : | May 27, 2024 |
Estimated Primary Completion Date : | February 2028 |
Estimated Study Completion Date : | February 2028 |
Arm | Intervention/treatment |
---|---|
Experimental: Fecal Microbiota Transplantation A single Fecal Microbiota Transplantation (FMT) with 100 g of healthy stool in 36-40 oral capsules once 24 hours after Polyethylene Glycol laxative preparation, followed by gemcitabine 1000 mg/m2 intravenously (IV) and nab-paclitaxel 125 mg/m2 IV on Day 1, Day 8, and Day 15 of each 28-day cycle at least 7 days after FMT. |
Drug: Fecal Microbiota Transplantation Drug: PEG3350 Drug: Gemcitabine Drug: nab-Paclitaxel |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Verspeeten Family Cancer Centre (formerly known as the London Regional Cancer Program) London Health Sciences Centre
London, Ontario, Canada, Wicker jumpsuit