Medical Food for the Dietary Management of Metastatic Colorectal Cancer

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    60
  • sponsor
    Faeth Therapeutics
Updated on 9 July 2022

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.

Details
Condition Metastatic Colorectal Cancer
Treatment NEAAR Medical Food
Clinical Study IdentifierNCT05183295
SponsorFaeth Therapeutics
Last Modified on9 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically confirmed metastatic and unresectable CRC
Age ≥ 18 years
ECOG Performance Status of ≤ 1
Subject is not receiving any other cancer therapy. Subjects participating in surveys or observational studies are allowed
Has failed treatment for fluoropyrimidine and oxaliplatin ± BEV
FOLFIRI ± BEV therapy is prescribed for the subject per standard of care
Subjects with measurable disease as determined by RECIST 1.1
Must have acceptable organ function
Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (1500/μL)
Platelet count ≥ 100 x 109/L
Hemoglobin ≥ 9 g/dL
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
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
Total serum bilirubin ≤ 1.5 x ULN (except for subjects with known Gilbert's Syndrome for which ≤ 3 x ULN is permitted)
Serum creatinine < 2.0 x ULN and creatinine clearance ≥50 mL/min/1.73m2
Serum albumin ≥3.5 mg/dL or ≥LLN, whichever is lower
Subjects must have available colorectal cancer (CRC) tissue samples from a primary or
metastatic site that has been biopsied within 6 months of screening and
provide consent for them to be obtained and analyzed
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

Concomitant MSI-H/dMMR (Microsatellite Instability High/Deficient Mismatch Repair)
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
More than one prior chemotherapy regimen administered in the metastatic setting
Major surgery within 6 weeks prior to randomization
Current brain metastasis
Women who are pregnant or breastfeeding
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)
Unable or unwilling to ingest the NEAAR medical food
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
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)
Clinically significant ascites or pleural effusions
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
The following are exclusion criteria for patients who received SOC BEV
History of cardiac disease: congestive heart failure (CHF) Class II or higher according to the New York Heart Association (NYHA); active coronary artery disease, myocardial infarction within 6 months prior to study entry; unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or cardiac arrhythmias requiring antiarrhythmic therapy (beta blockers or digoxin are permitted)
Current uncontrolled hypertension (systolic blood pressure [BP] > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management) or prior history of hypertensive crisis or hypertensive encephalopathy
History of arterial thrombotic or embolic events (within 6 months prior to study entry)
Significant vascular disease (e.g., aortic aneurysm, aortic dissection, symptomatic peripheral vascular disease)
Evidence of bleeding diathesis or clinically significant coagulopathy
Major surgical procedure (including open biopsy, significant traumatic injury, etc.) within 28 days, or anticipation of the need for major surgical procedure during the study, and minor surgical procedure (excluding placement of a vascular access device) within 7 days prior to study enrollment
Proteinuria at Screening as demonstrated by urinalysis with proteinuria ≥2+ (patients discovered to have ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible)
History of abdominal fistula, GI perforation, peptic ulcer, or intraabdominal abscess within 6 months
Ongoing serious, non-healing wound, ulcer, or bone fracture
Known hypersensitivity to any component of BEV
History of reversible posterior leukoencephalopathy syndrome (RPLS)
Comorbidity risk, that in the discretion of the investigator would make the subject a
poor candidate for the NEAAR medical food
A body mass index (BMI) <18.5 kg/m2 or >40 kg/m2, or serious or refractive cachexia or anorexia that, in the investigator's opinion, realistically prohibits subjects from having energy or appetite sufficient to reliably engage in a strict medical food regimen for an extended time
Insulin-dependent or poorly controlled diabetes
Subjects who must take medications that impact targeted amino acid levels
Inability or unwillingness to comply with study and/or follow-up procedures, or medical food modifications described in the protocol
Untreated clinically significant hyperlipidemia per investigator
Subjects with a condition (including gallbladder disease and/or fatty acid oxidation disorders or porphyria) where high-fat or fatty food is contraindicated
Presence of any condition (e.g., persistent diarrhea) that renders the subject unable to satisfactorily chew, swallow, digest, absorb, or tolerate the majority of foods and liquids of the NEAAR medical food, especially high-fat foods such as oils, cream, and butter
Taking or needs to take any protein or amino acid containing nutritional supplements (e.g., Ensure®)
Lack of physical integrity of the upper or lower gastrointestinal (GI) tract
History of confirmed food allergy
Unwillingness to consume small quantities of meat products and byproducts (for example fish sauce, bone marrow, chicken broth, etc.)
Diagnosis of previous or current eating disorder and/or disordered eating behaviors
Diagnosed with Crohn's disease, ulcerative colitis, or gluten-sensitive enteropathy (Celiac disease)
Has previous epidermal growth factor receptor inhibitor (EGFRi) therapy or a combined fluoropyrimidine and irinotecan plus oxaliplatin-based regimen (e.g, FOLFIRINOX) in the first line treatment
Is receiving or plans to receive a concomitant EGFRi inhibitor
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