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Metastatic Colorectal CancerNCT05183295

Medical Food for the Dietary Management of Metastatic Colorectal Cancer

A study testing NEAAR Medical Food in people with Metastatic Colorectal Cancer, run by Faeth Therapeutics.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
NEAAR Medical Food
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
27 Apr 2022to 27 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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 the most recently biopsied primary or metastatic site 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.

Who cannot join

  • 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.
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  • 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.

About this study

Official title: Prospective Single Arm Medical Food Study to Evaluate a Standardized Nonessential Amino Acid Restriction (NEAAR) Medical Food for the Dietary Management of Metastatic Colorectal Cancer

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.

Being tested
NEAAR Medical Food
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NEAAR Medical FoodOther

    Standardized non-essential amino acid restricted medical food

Study groups in NCT05183295
Study groupRoleWhat they receive
Experimental: Nonessential Amino Acid Restriction (NEAAR) Medical FoodExperimentalAll subjects will receive NEAAR medical food
Receives: Other: NEAAR Medical Food

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Through study completion (average of 6 months)

Secondary outcomes (3)

  1. Overall response rates

    Complete response and partial response per RECIST 1.1

    Measured: Through study completion (average of 6 months)

  2. Changes in biomarkers

    Absolute and relative change from baseline for disease biomarkers

    Measured: Through study completion (average of 6 months)

  3. Progression-free Survival

    Duration from radiographic documentation of disease to radiographic documentation of progression or death from any cause

    Measured: 6, 9 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2022
  2. Study start27 Apr 2022
  3. Primary completion27 Mar 2023
  4. Study completion27 Mar 2023

Why it stopped: Withdrawn by Sponsor.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05183295
Sponsor's protocol ID
NEAAR-002
Status last verified
Mar 2023
First submitted
21 Dec 2021
Last updated
3 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing NEAAR Medical Food in people with Metastatic Colorectal Cancer, run by Faeth Therapeutics.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tolerability of the NEAAR medical food (time frame: Through study completion (average of 6 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05183295.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.

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