Medical Food for the Dietary Management of Metastatic Pancreatic Cancer

  • STATUS
    Recruiting
  • End date
    Aug 14, 2023
  • participants needed
    60
  • sponsor
    Faeth Therapeutics
Updated on 14 June 2022

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 metastatic pancreatic adenocarcinoma. Subjects will be receiving two FDA approved first line drug therapies, gemcitabine and nab-paclitaxel (gem+nabP), that are routinely prescribed in combination for metastatic pancreatic cancer as part of their routine care.

Details
Condition Metastatic Pancreatic Cancer
Treatment NEAAR Medical Food
Clinical Study IdentifierNCT05078775
SponsorFaeth Therapeutics
Last Modified on14 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects presenting with histologically or cytologically confirmed metastatic pancreatic adenocarcinoma diagnosed within 6 weeks prior to screening
Subjects are eligible for and being scheduled to begin standard of care treatment with the gem+nabP regimen
Subjects who are 18 years of age or older
Subjects are capable of giving signed informed consent
ECOG Performance Status of ≤ 1
Subjects with measurable disease as determined by RECIST 1.1
Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (1500/µL)
Platelet count ≥ 100 x 109/L
Subject has adequate organ function during screening evaluations defined as all the
Hemoglobin ≥ 9 g/dL
following
Activated partial thromboplastin time /international normalized ratio (aPTT/INR) ≤ 1.5 x upper limit of normal (ULN) unless the subject is on anticoagulants in which case therapeutically acceptable values (as determined by the investigator) meet eligibility requirements
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 × ULN. In the case of known (i.e., radiological or biopsy documented) liver metastasis, serum transferase levels must be ≤ 5 x ULN
Total serum bilirubin ≤ 1.5 x ULN (except for subjects with known Gilbert's Syndrome for which ≤ 3 x ULN is permitted)
Serum creatinine < 2.0 x ULN and creatinine clearance ≥ 50 mL/min/1.73m2
Serum albumin ≥ 3.5mg/d or ≥LLN, whichever is lower
Subjects must have normal Vitamin D levels or be willing to start Vitamin D
supplementation during the NEAAR medical food period
Subjects must have available pancreatic adenocarcinoma tissue samples from a primary or metastatic site that has been biopsied within the last 6 months and provide consent for them to be obtained and analyzed
Subjects must be willing to stop taking any supplements, herbal medicines, or alternative remedies or other prescribed or over the counter supplements for at least 1 week prior to Cycle 1 Day 1 of gem+nabP and through the NEAAR medical food period
Subjects either have normal pancreatic function or are already taking Pancreatic Enzyme Replacement Therapy (PERT). If pancreatic insufficiency status is unknown, subjects must have a fecal elastase test to check for moderate or severe pancreatic insufficiency. Subjects with diagnosed pancreatic insufficiency must take PERT

Exclusion Criteria

A body mass index (BMI) <18.5 kg/m2 or >40 kg/m2 or, serious or refractive cachexia or anorexia that, in the investigator's opinion, realistically prohibits subjects from having energy or appetite sufficient to reliably engage in a strict medical food regimen for an extended time
Any prior neoadjuvant or adjuvant therapy for pancreatic cancer within 6 months of screening
Comorbidity risk, that in the discretion of the investigator would make the subject a poor candidate for the NEAAR medical food
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)
Insulin-dependent diabetes
Subjects who must take medications that impact amino acid levels
Inability or unwillingness to comply with study and/or follow-up procedures, or medical food modifications described in the protocol
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
Known hypersensitivity, intolerance, or religious restrictions regarding pork or pork-derived products or to any of the components of the medical food modification, gemcitabine or nab-paclitaxel, PERT products (e.g., Pancreaze), or formulary excipients in these products
Taking or needs to take any protein or amino acid containing nutritional supplements (e.g., Ensure®)
Untreated clinically significant hyperlipidemia per investigator
Subjects with a condition (including gallbladder disease and/or fatty acid oxidation disorders) where high-fat or fatty food is contraindicated
Any non-cancerous co-existing condition that could elevate CA19-9, CEA, or CA125
Presence of central nervous system or brain metastases that are not controlled under treatment as assessed by the investigator
Presence of any condition (e.g., persistent diarrhea) that renders the subject unable to satisfactorily chew, swallow, digest, or tolerate the majority of foods and liquids of the NEAAR medical food
Women who are, plan to be, or may potentially be pregnant or lactating
Lack of physical integrity of the upper or lower gastrointestinal (GI) tract
Known, existing uncontrolled coagulopathy
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
Active, clinically significant, uncontrolled bacterial, viral, or fungal infection(s)
Known current infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
History of confirmed food allergy
Currently enrolled in any other investigational trial or treatment with investigational therapy(ies)
Diagnosed with an eating disorder, irritable bowel syndrome (IBS), Crohn's disease, ulcerative colitis, or gluten-sensitive enteropathy
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