Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Micronutrients

All Drugs and Chemicals

Pharmaceutical Solutions

Gastrointestinal Agents

Vitamins

Ascorbic Acid

Laxatives

Polyethylene glycol 3350

Sodium sulfate

Cathartics

Vitamin C

Fixed evening dose plus alternative morning dose

Single evening dose of 750mL solution containing 100g PEG3350 plus 6g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.

NER1006

Single evening dose of 750mL solution containing 100g PEG3350 plus 9g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.

Single evening dose of 750mL solution containing 75g PEG3350 plus 5.6g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.

Reconstituted and administered in accordance with recommended split dose intake: one litre in the evening, one litre the following morning.

Moviprep

Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350 and 56.6g sodium ascorbate.

Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate and 21.4g magnesium ascorbate.

Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350, 6g sodium sulphate and 33.9g sodium ascorbate.

Single evening dose containing formulation selected from Part A of study. Single morning dose containing 29g PEG3350 and 4.8g sulphate and 23.3g ascorbic acid.

Rodica Cinca, MD

This study is to investigate the effect of various modified low volume polyethylene glycol (PEG) 3350 and ascorbic acid/ascorbate (PEG+ASC)-based gut cleansing solutions on stool output in healthy subjects. In addition, the study is to assess and compare the safety and tolerance of the modified PEG+ASC formulations following oral administration with the safety profile of MOVIPREP®.

Pharmacodynamic Evaluation of Stool Output Following Oral Administration of Various Low Volume PEG3350-based Gut Cleansing Solutions Using the Split Dose Intake in Healthy Subjects

Stool weight output generated from the start of intake for the following 24 hours.

Concentration of PEG3350 in blood, urine and faeces.

Concentration of ascorbic acid in blood, urine and faeces.

Concentration of electrolytes in blood, urine and faeces.

Spontaneouly reported adverse events will be recorded throughout the study

Pierrel Research Europe GmbH

Norgine

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antimetabolites

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.

Fecal Microbiota Transplantation with 100 g of healthy donor stool in 36-40 oral capsules once

Other Names:

* FMT
* Stool Transplant
* Poop Transplant

Fecal Microbiota Transplantation

Polyethylene Glycol 3350 17 g oral dissolved in 4 litres of water consumed the evening before FMT.

Other Names:

* PEG3350
* RestoraLAX
* MiraLAX

PEG3350

Gemcitabine 1000 mg/m2/day IV on Days 1, 8, and 15 of each 28-day cycle.

Other Names:

- Gemzar

nab-Paclitaxel 125 mg/m2/day IV on Days 1, 8, and 15 of each 28-day cycle.

Other Names:

- Abraxane

nab-Paclitaxel

John G Lenehan, MD

John G Lenehan, MD, FRCPC

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.

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.

CHemotherapy And Stool Transplant in PDAC (CHASe-PDAC)

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.

FMT in combination with systemic therapy in patients with advanced PDAC has not been studied to our knowledge. Prior to proceeding with a larger study, this phase I study will include 20 patients receiving G-nP who will receive a single FMT with healthy donor stool prior to the first dose of chemotherapy. There are well-known toxicities associated with these 2 chemotherapeutic agents, several of which affect the gastrointestinal tract. The most common side effects resulting from FMT are primarily mild gastrointestinal effects. FMT has been found to be safe when combined with ICIs and there has been no increase in the number of toxicities or severity observed. The measure of safety in this trial will be assessing for treatment-related adverse events that will be graded according to the NCI-CTCAE v5. A positive trial result with respect to toxicity will be designated if there are no unexpected or more severe toxicities associated than with the chemotherapy drugs alone.

Determined using RECIST 1.1 criteria to evaluate changes in tumour size on routine imaging and quantified using the Kaplan-Meier method.

Quantified using the Kaplan-Meier method alone.

The tolerability of consuming approximately 40 capsules in patients with PDAC will be assessed by study personnel through direct observation of the FMT process. Patients with advanced PDAC are often unwell, cachectic, anorexic, and experiencing nausea associated with the cancer process. Adequate intake of calories and hydration are routinely a challenge in this patient population. Before a larger study can be contemplated, the feasibility and tolerability of consuming the large number of capsules needs to be demonstrated in a smaller study like this.

A reduction in size of PDAC tumours is often not achieved or dramatic when they occur, therefore the ORR is not considered a benchmark of success in this study. However, some patients may benefit from a reduction in tumour volume with respect to cancer-related symptoms such as gastric outlet obstruction resulting from extrinsic compression by the tumour. The ORR will be assessed given its potential to be clinically meaningful and will be determined using the RECIST 1.1 criteria.

The CBR may be more clinically relevant to patients with PDAC where SD directly relates to the duration of PFS and few achieve a CR or PR.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pharmacodynamic Evaluation of Stool Output Following Oral Administration of Various Low Volume PEG3350-based Gut Cleansing Solutions Using the Split Dose Intake in Healthy Subjects	NCT01834742	Colorectal Canc...	NER1006 NER1006 NER1006 Moviprep NER1006 NER1006 NER1006 NER1006	18 Years - 45 Years	Norgine
CHemotherapy And Stool Transplant in PDAC (CHASe-PDAC)	NCT06393400	Unresectable or...	Fecal Microbiot... PEG3350 Gemcitabine nab-Paclitaxel	18 Years -	Lawson Health Research Institute
Pharmacodynamic Evaluation of Stool Output Following Oral Administration of Various Low Volume PEG3350-based Gut Cleansing Solutions Using the Split Dose Intake in Healthy Subjects	NCT01834742	Colorectal Canc...	NER1006 NER1006 NER1006 Moviprep NER1006 NER1006 NER1006 NER1006	18 Years - 45 Years	Norgine

Spots Global Cancer Trial Database for peg3350

Every month we try and update this database with for peg3350 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for peg3350

Every month we try and update this database with for peg3350 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for peg3350 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.