Locally Advanced Unresectable Pancreatic Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma
Conditions
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.
Interventions
OTHERNEAAR Medical Food
Standardized non-essential amino acid restricted medical food.
Sponsors
Faeth Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demonstrate tolerability of the NEAAR medical food. | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall response rates | Through study completion (average of 6 months) | Complete response and partial response using RECIST 1.1 |
| Duration of best response | Through study completion (average of 6 months) | — |
| Changes in biomarkers | Through study completion (average of 6 months) | Absolute and relative change from baseline of disease biomarkers |
| Progression-free survival | Through study completion (average of 6 months) | Duration from radiographic documentation of disease to radiographic documentation of progression or death from any cause |
Countries
United States
Outcome results
None listed