Metastatic Pancreatic AdenocarcinomaNCT05078775
Medical Food for the Dietary Management of Advanced/Metastatic Pancreatic Cancer
A study testing NEAAR Medical Food in people with Metastatic Pancreatic Adenocarcinoma and Locally Advanced Unresectable Pancreatic Adenocarcinoma, run by Faeth Therapeutics at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Adenocarcinoma, Locally Advanced Unresectable Pancreatic Adenocarcinoma
- What is being tested?
- NEAAR Medical Food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 9 sitesUnited States
- Study dates
- 21 Dec 2021to 10 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Baptist Hospitals of Southeast Texas
Beaumont, Texas, 77701
Florida Cancer Specialists
Fort Myers, Florida, 33901
Oncology Physicians Network
Glendale, California, 91203
Cedars-Sinai
Los Angeles, California, 900481804
Atlantic Health
Morristown, New Jersey, 07962
Sarah Cannon
Nashville, Tennessee, 37203
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
xCures - Virtual Site
Raleigh, North Carolina, 27612
University of Arizona Cancer Center
Tucson, Arizona, 85724
About this study
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
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.
- Conditions
- Metastatic Pancreatic Adenocarcinoma, Locally Advanced Unresectable Pancreatic Adenocarcinoma
- Being tested
- NEAAR Medical Food
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEAAR Medical FoodOther
Standardized non-essential amino acid restricted medical food.
| Study group | Role | What they receive |
|---|---|---|
| Nonessential Amino Acid Restriction (NEAAR) Medical Food | Experimental | This is a single arm study in which all subjects will receive NEAAR medical food. Receives: Other: NEAAR Medical Food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate tolerability of the NEAAR medical food.
The primary endpoint is the rate of the most common Grade 3 and 4 adverse event (AE) related to the NEAAR medical food.
Measured: Through study completion (average of 6 months)
Secondary outcomes (4)
Overall response rates
Complete response and partial response using RECIST 1.1
Measured: Through study completion (average of 6 months)
Duration of best response
Measured: Through study completion (average of 6 months)
Changes in biomarkers
Absolute and relative change from baseline of disease biomarkers
Measured: Through study completion (average of 6 months)
Progression-free survival
Duration from radiographic documentation of disease to radiographic documentation of progression or death from any cause
Measured: Through study completion (average of 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start21 Dec 2021
- Primary completion10 Jul 2025
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faeth Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Hendifar, MD, Principal investigator, Cedars-Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078775
- Sponsor's protocol ID
- NEAAR-001
- Status last verified
- Jul 2025
- First submitted
- 1 Sep 2021
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05078775
- Acronym / sponsor ID
- NEAAR-001
- Conditions
- Metastatic Pancreatic Adenocarcinoma, Locally Advanced Unresectable Pancreatic Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Faeth TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nonessential Amino Acid Restriction (NEAAR) Medical Food | Experimental | Other: NEAAR Medical FoodThis is a single arm study in which all subjects will receive NEAAR medical food. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEAAR Medical FoodStandardized non-essential amino acid restricted medical food. | Other | Nonessential Amino Acid Restriction (NEAAR) Medical Food |
Primary outcome
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.
4 secondary outcomes
Overall response rates
Time frame: Through study completion (average of 6 months)
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)
Progression-free survival
Time frame: Through study completion (average of 6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Hendifar, MD principal investigator
Cedars-Sinai
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEAAR Medical Food in people with Metastatic Pancreatic Adenocarcinoma and Locally Advanced Unresectable Pancreatic Adenocarcinoma, run by Faeth Therapeutics at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate tolerability of the NEAAR medical food. (time frame: Through study completion (average of 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.