Metastatic Colorectal Cancer
Conditions
Brief summary
This is a single arm study evaluating the tolerability and markers of colorectal cancer with a specially designed medical food restricted in specific amino acids for the dietary management of subjects with metastatic colorectal cancer. Subjects will be receiving two FDA approved second line drug therapies, fluoropyrimidine and oxaliplatin ± bevacizumab (FOLFIRI + BEV) that are routinely prescribed in combination for metastatic colorectal cancer as part of their routine care.
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
1. Histologically confirmed metastatic and unresectable CRC. 2. Age ≥ 18 years. 3. ECOG Performance Status of ≤ 1. 4. Subject is not receiving any other cancer therapy. Subjects participating in surveys or observational studies are allowed. 5. Has failed treatment for fluoropyrimidine and oxaliplatin ± BEV. 6. FOLFIRI ± BEV therapy is prescribed for the subject per standard of care. 7. Subjects with measurable disease as determined by RECIST 1.1. 8. Must have acceptable organ function. 1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (1500/μL). 2. Platelet count ≥ 100 x 109/L. 3. Hemoglobin ≥ 9 g/dL 4. Activated partial thromboplastin time/international normalized ratio (aPTT/ INR) ≤ 1.5 x upper limit of normal (ULN) unless the subject is on anticoagulants in which case therapeutically acceptable values (as determined by the investigator) meet eligibility requirements. 5. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5 × ULN. In the case of known (i.e., radiological or biopsy documented) liver metastasis, serum transaminase levels must be ≤ 5 x ULN. 6. Total serum bilirubin ≤ 1.5 x ULN (except for subjects with known Gilbert's Syndrome for which ≤ 3 x ULN is permitted). 7. Serum creatinine \< 2.0 x ULN and creatinine clearance ≥50 mL/min/1.73m2 8. Serum albumin ≥3.5 mg/dL or ≥LLN, whichever is lower 9. Subjects must have available colorectal cancer (CRC) tissue samples from the most recently biopsied primary or metastatic site and provide consent for them to be obtained and analyzed. 10. Subjects must be willing to stop taking any supplements, herbal medicines, or alternative remedies or other prescribed or over the counter supplements for at least 1 week prior to Cycle 1 Day 1 of FOLFIRI ± BEV and through the NEAAR medical food period.
Exclusion criteria
1. Concomitant MSI-H/dMMR (Microsatellite Instability High/Deficient Mismatch Repair) 2. Anti-cancer chemotherapy or biologic therapy administered within 3 weeks prior to the first dose of fluoropyrimidine and irinotecan-based regimens . The exception is a single dose of radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days before NEAAR medical food and return to baseline or ≤ Grade 1 toxicity associated with the radiation therapy. 3. More than one prior chemotherapy regimen administered in the metastatic setting. 4. Major surgery within 6 weeks prior to randomization. 5. Current brain metastasis. 6. Women who are pregnant or breastfeeding. 7. Gastrointestinal (GI) disorder(s) that, in the opinion of the investigator, would significantly impede the absorption of an oral agent (e.g., intestinal occlusion, active Crohn's disease, ulcerative colitis, extensive gastric, and small intestine resection). Exception: ostomy with normal daily stool output (\<2L output). 8. Unable or unwilling to ingest the NEAAR medical food. 9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure (CHF) Class II or higher according to the New York Heart Association (NYHA) Functional Classification, unstable angina pectoris, clinically significant cardiac arrhythmia, cardiac stent placement \< 3 months prior to the NEAAR run in period, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements. 1. Known active infection with Human Immunodeficiency Virus (HIV) and/or active infection with hepatitis B or C (patients who have had a hepatitis B virus \[HBV\] immunization are eligible). 2. Clinically significant ascites or pleural effusions. 10. Diagnosis of another malignancy within the past 2 years (excluding a history of carcinoma in situ of the cervix, superficial non-melanoma skin cancer, 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).Any active disease condition that would render the protocol treatment dangerous or impair the ability of the patient to receive NEAAR 11. The following are
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of the NEAAR medical food | Through study completion (average of 6 months) | 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 per RECIST 1.1 |
| Changes in biomarkers | Through study completion (average of 6 months) | Absolute and relative change from baseline for disease biomarkers |
| Progression-free Survival | 6, 9 and 12 months | Duration from radiographic documentation of disease to radiographic documentation of progression or death from any cause |
Outcome results
None listed