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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Standardized non-essential amino acid restricted medical food.
University of Arizona Cancer Center
Tucson, Arizona, United States
Oncology Physicians Network
Glendale, California, United States
Cedars-Sinai
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Demonstrate tolerability of the NEAAR medical food.
The primary endpoint is the rate of the most common Grade 3 and 4 adverse event (AE) related to the NEAAR medical food.
Time frame: Through study completion (average of 6 months)
Overall response rates
Complete response and partial response using RECIST 1.1
Time frame: Through study completion (average of 6 months)
Duration of best response
Time frame: Through study completion (average of 6 months)
Changes in biomarkers
Absolute and relative change from baseline of disease biomarkers
Time frame: Through study completion (average of 6 months)
Progression-free survival
Duration from radiographic documentation of disease to radiographic documentation of progression or death from any cause
Time frame: Through study completion (average of 6 months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Newport Beach, California, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Atlantic Health
Morristown, New Jersey, United States
xCures - Virtual Site
Raleigh, North Carolina, United States
Sarah Cannon
Nashville, Tennessee, United States
Baptist Hospitals of Southeast Texas
Beaumont, Texas, United States