Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nonessential Amino Acid Restriction (NEAAR) Medical Food | Experimental | This is a single arm study in which all subjects will receive NEAAR medical food. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEAAR Medical Food | Other | Standardized non-essential amino acid restricted medical food. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion (average of 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rates | Complete response and partial response using RECIST 1.1 | Through study completion (average of 6 months) |
| Duration of best response | Through study completion (average of 6 months) |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrew Hendifar, MD | Cedars-Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Cancer Center | Tucson | Arizona | 85724 | United States | ||
| Oncology Physicians Network |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Changes in biomarkers | Absolute and relative change from baseline of disease biomarkers | 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 | Through study completion (average of 6 months) |
| Glendale |
| California |
| 91203 |
| United States |
| Cedars-Sinai | Los Angeles | California | 900481804 | United States |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92663 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33901 | United States |
| Atlantic Health | Morristown | New Jersey | 07962 | United States |
| xCures - Virtual Site | Raleigh | North Carolina | 27612 | United States |
| Sarah Cannon | Nashville | Tennessee | 37203 | United States |
| Baptist Hospitals of Southeast Texas | Beaumont | Texas | 77701 | United States |