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

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 Overview

• Status: Completed
• Conditions: Metastatic Pancreatic Adenocarcinoma; Locally Advanced Unresectable Pancreatic Adenocarcinoma
• Intervention / Treatment: Other: NEAAR Medical Food

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona Cancer Center
  • California
    • Glendale, California, United States, 91203
      • Oncology Physicians Network
    • Los Angeles, California, United States, 900481804
      • Cedars-Sinai
    • Newport Beach, California, United States, 92663
      • Hoag Memorial Hospital Presbyterian
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Florida Cancer Specialists
  • New Jersey
    • Morristown, New Jersey, United States, 07962
      • Atlantic Health
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • xCures - Virtual Site
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon
  • Texas
    • Beaumont, Texas, United States, 77701
      • Baptist Hospitals of Southeast Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Signed informed consent form (ICF) by subject.
2. Histologically or cytologically confirmed pancreatic adenocarcinoma.
3. Locally advanced and unresectable or metastatic pancreatic adenocarcinoma.
4. Eligible for standard of care treatment with the gem+nabP regimen.
5. 18 years of age or older.
6. Measurable disease as determined by RECIST 1.1 (at least one measurable lesion must not have been irradiated in the past).
7. ECOG Performance Status of ≤ 1.
8. Adequate organ function during screening evaluation
9. Available pancreatic adenocarcinoma tissue samples from a primary or metastatic site that has been biopsied within the last 12 months and provide consent for them to be obtained and analyzed by the study sponsor to assist in determining final eligibility. A minimum of five (ten preferred) formalin fixed paraffin embedded (FFPE) archival or fresh tumor tissue slides are required.

Key Exclusion Criteria:

1. Any prior neoadjuvant or adjuvant therapy for pancreatic cancer within 6 months of screening.
2. Any prior therapy for metastatic pancreatic cancer or locally advanced and unresectable pancreatic cancer (except for neoadjuvant or adjuvant therapy as noted above in exclusion criteria 1)
3. Known cerebral metastasis.
4. Diagnosis of another malignancy within the past 2 years (excluding a history of carcinoma in situ of the cervix, superficial non-melanoma skin cancer, or superficial bladder cancer that has been adequately treated, or stage 1 prostate cancer that does not require treatment or requires only treatment with luteinizing hormone-releasing hormone agonists or antagonists if initiated at least 30 days prior to beginning the NEAAR medical food).
5. Body mass index (BMI) <18.5 kg/m2 or >40 kg/m2 or serious or refractive cachexia or anorexia that, in the investigator's judgment, prohibits subjects from having energy or appetite sufficient to reliably engage in a strict medical food regimen for an extended time.
6. Presence of any significant comorbidity including clinically significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication), myocardial infarction or unstable angina within the 12 months prior to screening, or any major organ failure.
7. Known hypersensitivity, allergy, or religious restrictions regarding pork or pork-derived products; or known allergy to any of the major food allergens as defined by U.S. law (milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame); or known allergy or hypersensitivity to , gemcitabine or nab-paclitaxel, PERT products (e.g., Pancreaze), or formulary excipients in these products (refer to the FDA-approved package insert).
8. Major surgery or significant traumatic injury within 14 days of planned start of NEAAR medical food or the anticipation of the need for a major surgical procedure during the study.
9. Unwillingness to consume small quantities of meat products and byproducts (e.g., fish sauce, bone marrow, chicken broth).
10. Diagnosed with an eating disorder, irritable bowel syndrome (IBS), Crohn's disease, ulcerative colitis, or gluten-sensitive enteropathy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nonessential Amino Acid Restriction (NEAAR) Medical Food; This is a single arm study in which all subjects will receive NEAAR medical food.	Other: NEAAR Medical Food; Standardized non-essential amino acid restricted medical food.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through study completion (average of 6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rates	Complete response and partial response using RECIST 1.1	Through study completion (average of 6 months)
Changes in biomarkers	Absolute and relative change from baseline of disease biomarkers	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	Through study completion (average of 6 months)
Duration of best response		Through study completion (average of 6 months)

Collaborators and Investigators

• Sponsor: Faeth Therapeutics
• Investigators: Principal Investigator: Andrew Hendifar, MD, Cedars-Sinai

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2021
• Primary Completion (Actual): July 10, 2025
• Study Completion (Actual): July 10, 2025

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma
• Other Study ID Numbers: NEAAR-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No