Medical Food for the Dietary Management of Advanced/Metastatic Pancreatic Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-21

Study Completion Date

2025-07-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Gemcitabine Chemoradiation and TNP-470 Patients Locally Advanced, Nonmetastatic Adenocarcinoma of Pancreas

NCT00038701

Pancreatic Neoplasms

TERMINATED PHASE2

Stereotactic Radiation, Nelfinavir Mesylate & Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer

NCT01068327

Adenocarcinoma of the Pancreas Stage III Pancreatic Cancer

COMPLETED PHASE1

New and Emerging Therapies for the Treatment of Resectable, Borderline Resectable, or Locally Advanced Pancreatic Cancer, PIONEER-Panc Study

NCT04481204

Borderline Resectable Pancreatic Adenocarcinoma Locally Advanced Pancreatic Ductal Adenocarcinoma Resectable Pancreatic Ductal Adenocarcinoma

ACTIVE_NOT_RECRUITING PHASE2

Phase 2, Nab Paclitaxel/Gemcitabine Alone and in Combination With ACP-196 in Subjects With Metastatic Pancreatic Cancer

NCT02570711

Metastatic Pancreatic Cancer

TERMINATED PHASE2

A Phase II Study to Assess the Efficacy and Safety of Preoperative Chemo With Radiation Therapy for Patients With Borderline Unresectable Adenocarcinoma of the Pancreas

NCT01240304

Pancreatic Cancer

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Pancreatic Adenocarcinoma Locally Advanced Unresectable Pancreatic Adenocarcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nonessential Amino Acid Restriction (NEAAR) Medical Food

This is a single arm study in which all subjects will receive NEAAR medical food.

Group Type EXPERIMENTAL

NEAAR Medical Food

Intervention Type OTHER

Standardized non-essential amino acid restricted medical food.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NEAAR Medical Food

Standardized non-essential amino acid restricted medical food.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Exclusion Criteria

1. Any prior neoadjuvant or adjuvant therapy for pancreatic cancer within 6 months of screening.
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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No