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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
Sponsor:
Information provided by (Responsible Party):
Faeth Therapeutics

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Adenocarcinoma Locally Advanced Unresectable Pancreatic Adenocarcinoma Other: NEAAR Medical Food Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Overall response rates [ Time Frame: Through study completion (average of 6 months) ]
    Complete response and partial response using RECIST 1.1

  2. Duration of best response [ Time Frame: Through study completion (average of 6 months) ]
  3. Changes in biomarkers [ Time Frame: Through study completion (average of 6 months) ]
    Absolute and relative change from baseline of disease biomarkers

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Faeth Therapeutics (708) 406-9282‬ info@faeththerapeutics.com

Locations
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United States, Arizona
University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Brianna Loughran    520-694-9057    bloughran@arizona.edu   
United States, California
Cedars-Sinai Recruiting
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
Atlantic Health Recruiting
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    sginn@xcures.com   
United States, Tennessee
Sarah Cannon Recruiting
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    telice.terro@bhset.net   
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    badion@mcw.edu   
Sponsors and Collaborators
Faeth Therapeutics
Investigators
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Principal Investigator: Andrew Hendifar, MD Cedars-Sinai
More Information
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Responsible Party: Faeth Therapeutics
ClinicalTrials.gov Identifier: NCT05078775    
Other Study ID Numbers: NEAAR-001
First Posted: October 14, 2021    Key Record Dates
Last Update Posted: April 3, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms