Medical Food for the Dietary Management of Advanced/Metastatic Pancreatic Cancer (NCT05078775) | Clinical Trial Compass
CompletedNot Applicable
Medical Food for the Dietary Management of Advanced/Metastatic Pancreatic Cancer
United States39 participantsStarted 2021-12-21
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed informed consent form (ICF) by subject.
✓. Histologically or cytologically confirmed pancreatic adenocarcinoma.
✓. Locally advanced and unresectable or metastatic pancreatic adenocarcinoma.
✓. Eligible for standard of care treatment with the gem+nabP regimen.
✓. 18 years of age or older.
✓. Measurable disease as determined by RECIST 1.1 (at least one measurable lesion must not have been irradiated in the past).
✓. ECOG Performance Status of ≤ 1.
✓. Adequate organ function during screening evaluation
Exclusion criteria
✕. Any prior neoadjuvant or adjuvant therapy for pancreatic cancer within 6 months of screening.
✕. 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)
✕. Known cerebral metastasis.
✕. 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).
What they're measuring
1
Demonstrate tolerability of the NEAAR medical food.
Timeframe: Through study completion (average of 6 months)
✕. 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.
✕. 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, 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).
✕. 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.