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