Medical Food for the Dietary Management of Metastatic Colorectal Cancer

NCT05183295 | Withdrawn

• 1 other identifier: NEAAR-002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Tolerability of the NEAAR medical food

  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)

Secondary Outcomes (3)

• Overall response rates

  Through study completion (average of 6 months)

• Changes in biomarkers

  Through study completion (average of 6 months)

• Progression-free Survival

  6, 9 and 12 months

Study Arms (1)

Experimental: Nonessential Amino Acid Restriction (NEAAR) Medical Food

EXPERIMENTAL

All subjects will receive NEAAR medical food

Other: NEAAR Medical Food

Interventions

NEAAR Medical Food OTHER

Standardized non-essential amino acid restricted medical food

Experimental: Nonessential Amino Acid Restriction (NEAAR) Medical Food

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Faeth Therapeutics: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Andrea Cerceck, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 10, 2022
• Study Start: April 27, 2022
• Primary Completion: March 27, 2023
• Study Completion: March 27, 2023
• Last Updated: April 3, 2023

Record last verified: 2023-03