Medical Food for the Dietary Management of Advanced/Metastatic Pancreatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05078775|
Recruitment Status : Recruiting
First Posted : October 14, 2021
Last Update Posted : April 3, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Metastatic Pancreatic Adenocarcinoma Locally Advanced Unresectable Pancreatic Adenocarcinoma||Other: NEAAR Medical Food||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||December 21, 2021|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||August 2023|
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.
- Demonstrate tolerability of the NEAAR medical food. [ Time Frame: Through study completion (average of 6 months) ]The primary endpoint is the rate of the most common Grade 3 and 4 adverse event (AE) related to the NEAAR medical food.
- Overall response rates [ Time Frame: Through study completion (average of 6 months) ]Complete response and partial response using RECIST 1.1
- Duration of best response [ Time Frame: Through study completion (average of 6 months) ]
- Changes in biomarkers [ Time Frame: Through study completion (average of 6 months) ]Absolute and relative change from baseline of disease biomarkers
- Progression-free survival [ Time Frame: Through study completion (average of 6 months) ]Duration from radiographic documentation of disease to radiographic documentation of progression or death from any cause
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Key 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
- 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:
- 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).
- 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.
- Unwillingness to consume small quantities of meat products and byproducts (e.g., fish sauce, bone marrow, chicken broth).
- Diagnosed with an eating disorder, irritable bowel syndrome (IBS), Crohn's disease, ulcerative colitis, or gluten-sensitive enteropathy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05078775
|Contact: Faeth Therapeutics||(708) firstname.lastname@example.org|
|United States, Arizona|
|University of Arizona Cancer Center||Recruiting|
|Tucson, Arizona, United States, 85724|
|Contact: Brianna Loughran 520-694-9057 email@example.com|
|United States, California|
|Los Angeles, California, United States, 900481804|
|Contact: Investigative Site 310-423-3277|
|Hoag Memorial Hospital Presbyterian||Recruiting|
|Newport Beach, California, United States, 92663|
|Contact: Hoag Clinical Research 949-557-0290|
|Contact: Backup (949) 764-4577|
|United States, Florida|
|Florida Cancer Specialists||Recruiting|
|Fort Myers, Florida, United States, 33901|
|Contact: Investigative Site 239-274-9930 ClinicalTrials@FLCancer.com|
|United States, Louisiana|
|Louisiana State University Health Sciences Center||Withdrawn|
|Shreveport, Louisiana, United States, 71103|
|United States, New Jersey|
|Morristown, New Jersey, United States, 07962|
|Contact: Nancy Ginder, RN, BSN 973-971-6608 Nancy.Ginder@atlantichealth.org|
|Principal Investigator: Angela Alistar, MD|
|United States, North Carolina|
|xCures - Virtual Site||Recruiting|
|Raleigh, North Carolina, United States, 27612|
|Contact: Sarah Ginn 919-649-4756 firstname.lastname@example.org|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|Contact: Ethan Trull 615-982-2139|
|United States, Texas|
|Baptist Hospitals of Southeast Texas||Recruiting|
|Beaumont, Texas, United States, 77701|
|Contact: Telice Terro 409-212-5979 email@example.com|
|Baylor Scott & White Health||Withdrawn|
|Temple, Texas, United States, 76508|
|United States, Wisconsin|
|Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Barbara Dion 414-805-4639 firstname.lastname@example.org|
|Principal Investigator:||Andrew Hendifar, MD||Cedars-Sinai|
|Responsible Party:||Faeth Therapeutics|
|Other Study ID Numbers:||
|First Posted:||October 14, 2021 Key Record Dates|
|Last Update Posted:||April 3, 2023|
|Last Verified:||March 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type