Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

All subjects will receive NEAAR medical food

Standardized non-essential amino acid restricted medical food

NEAAR Medical Food

Andrea Cerceck, MD

This is a single arm study evaluating the tolerability and markers of colorectal cancer with a specially designed medical food restricted in specific amino acids for the dietary management of subjects with metastatic colorectal cancer. Subjects will be receiving two FDA approved second line drug therapies, fluoropyrimidine and oxaliplatin ± bevacizumab (FOLFIRI + BEV) that are routinely prescribed in combination for metastatic colorectal cancer as part of their routine care.

Medical Food for the Dietary Management of Metastatic Colorectal Cancer

Prospective Single Arm Medical Food Study to Evaluate a Standardized Nonessential Amino Acid Restriction (NEAAR) Medical Food for the Dietary Management of Metastatic Colorectal Cancer

Rate of the most common Grade 3 and 4 adverse event (AE) related to the NEAAR medical food.

Complete response and partial response per RECIST 1.1

Absolute and relative change from baseline for disease biomarkers

Duration from radiographic documentation of disease to radiographic documentation of progression or death from any cause

Faeth Therapeutics

Rectal Neoplasms

This is a single arm study in which all subjects will receive NEAAR medical food.

Standardized non-essential amino acid restricted medical food.

Jennifer Burgess, MS

Veronique Perry, MHSA

Veronique Perry, MSHA

Richard Tuli, MD

Richard R Tuli, MD

This clinical study aims to assess feasibility, safety, tolerability, and compliance of a Nonessential Amino Acid Restriction (NEAAR) medical food in adult patients with locally advanced rectal cancer during standard of care short course radiotherapy followed by standard of care chemotherapy.

Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)

Prospective, Single Arm IIA Study to Evaluate the Feasibility of a Standardized Nonessential Amino Acid Restriction (NEAAR) Medical Food in Combination With Total Neoadjuvant Therapy (TNT) for Management of Locally Advanced Rectal Cancer (LARC) NEAAR-LARC

University of South Florida

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Cancer

Brianna Loughran

Heather Lion

Investigative Site

Hoag Clinical Research

Backup

Sarah Ginn

Ethan Trull

Telice Terro

Andrew Hendifar, MD

This is a single arm study evaluating the tolerability and markers of pancreatic cancer with a specially designed medical food restricted in specific amino acids for the dietary management of subjects with locally advanced and unresectable or metastatic pancreatic adenocarcinoma. Subjects who are eligible to receive two FDA approved first line drug therapies, gemcitabine and nab-paclitaxel (gem+nabP), routinely prescribed in combination for pancreatic cancer may be included in this study.

Medical Food for the Dietary Management of Advanced/Metastatic Pancreatic Cancer

Prospective, Single Arm Medical Food Study to Evaluate a Standardized Nonessential Amino Acid Restriction (NEAAR) Medical Food for the Dietary Management of Advanced/Metastatic Pancreatic Cancer

The primary endpoint is the rate of the most common Grade 3 and 4 adverse event (AE) related to the NEAAR medical food.

Complete response and partial response using RECIST 1.1

Absolute and relative change from baseline of disease biomarkers

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Medical Food for the Dietary Management of Metastatic Colorectal Cancer	NCT05183295	Metastatic Colo...	NEAAR Medical F...	18 Years -	Faeth Therapeutics
Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)	NCT06380101	Rectal Cancer	NEAAR Medical F...	18 Years - 100 Years	University of South Florida
Medical Food for the Dietary Management of Metastatic Colorectal Cancer	NCT05183295	Metastatic Colo...	NEAAR Medical F...	18 Years -	Faeth Therapeutics
Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)	NCT06380101	Rectal Cancer	NEAAR Medical F...	18 Years - 100 Years	University of South Florida
Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)	NCT06380101	Rectal Cancer	NEAAR Medical F...	18 Years - 100 Years	University of South Florida
Medical Food for the Dietary Management of Advanced/Metastatic Pancreatic Cancer	NCT05078775	Metastatic Panc... Locally Advance...	NEAAR Medical F...	18 Years -	Faeth Therapeutics

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