NCT05078775

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Faeth Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Metastatic Pancreatic Adenocarcinoma
• Locally Advanced Unresectable Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
OTHER	NEAAR Medical Food	Standardized non-essential amino acid restricted medical food.

Timeline

• Start date: 2021-12-21
• Primary completion: 2025-07-10
• Completion: 2025-07-10
• First posted: 2021-10-14
• Last updated: 2025-07-18

Locations

9 sites across 1 country: United States