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Trial record 2 of 3 for:    FAETH [Lead]

Medical Food for the Dietary Management of Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05183295
Recruitment Status : Recruiting
First Posted : January 10, 2022
Last Update Posted : June 24, 2022
Sponsor:
Information provided by (Responsible Party):
Faeth Therapeutics

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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Other: NEAAR Medical Food Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 27, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental: Nonessential Amino Acid Restriction (NEAAR) Medical Food
All subjects will receive NEAAR medical food
Other: NEAAR Medical Food
Standardized non-essential amino acid restricted medical food




Primary Outcome Measures :
  1. Tolerability of the NEAAR medical food [ Time Frame: 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 Outcome Measures :
  1. Overall response rates [ Time Frame: Through study completion (average of 6 months) ]
    Complete response and partial response per RECIST 1.1

  2. Changes in biomarkers [ Time Frame: Through study completion (average of 6 months) ]
    Absolute and relative change from baseline for disease biomarkers

  3. Progression-free Survival [ Time Frame: 6, 9 and 12 months ]
    Duration from radiographic documentation of disease to radiographic documentation of progression or death from any cause



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 a primary or metastatic site that has been biopsied within 6 months of screening 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 exclusion criteria for patients who received SOC BEV:

    1. 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).
    2. 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.
    3. History of arterial thrombotic or embolic events (within 6 months prior to study entry).
    4. Significant vascular disease (e.g., aortic aneurysm, aortic dissection, symptomatic peripheral vascular disease).
    5. Evidence of bleeding diathesis or clinically significant coagulopathy.
    6. 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.
    7. 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).
    8. History of abdominal fistula, GI perforation, peptic ulcer, or intraabdominal abscess within 6 months.
    9. Ongoing serious, non-healing wound, ulcer, or bone fracture.
    10. Known hypersensitivity to any component of BEV.
    11. History of reversible posterior leukoencephalopathy syndrome (RPLS).
  12. Comorbidity risk, that in the discretion of the investigator would make the subject a poor candidate for the NEAAR medical food.
  13. 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.
  14. Insulin-dependent or poorly controlled diabetes.
  15. Subjects who must take medications that impact targeted amino acid levels
  16. Inability or unwillingness to comply with study and/or follow-up procedures, or medical food modifications described in the protocol.
  17. Untreated clinically significant hyperlipidemia per investigator.
  18. Subjects with a condition (including gallbladder disease and/or fatty acid oxidation disorders or porphyria) where high-fat or fatty food is contraindicated.
  19. 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.
  20. Taking or needs to take any protein or amino acid containing nutritional supplements (e.g., Ensure®).
  21. Lack of physical integrity of the upper or lower gastrointestinal (GI) tract.
  22. History of confirmed food allergy.
  23. Unwillingness to consume small quantities of meat products and byproducts (for example fish sauce, bone marrow, chicken broth, etc.).
  24. Diagnosis of previous or current eating disorder and/or disordered eating behaviors.
  25. Diagnosed with Crohn's disease, ulcerative colitis, or gluten-sensitive enteropathy (Celiac disease).
  26. 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.
  27. Is receiving or plans to receive a concomitant EGFRi inhibitor.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05183295


Contacts
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Contact: Faeth Therapeutics (650) 488-1109 clinicaltrials@faeththerapeutics.com

Locations
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United States, Arizona
University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85719
Contact: Investigative Site    520-694-2873      
United States, California
Cedars-Sinai Health System Not yet recruiting
Beverly Hills, California, United States, 90210
Contact: Trial Coordinator    949-945-3501      
Principal Investigator: Jun Gong, MD         
United States, Tennessee
Verdi Oncology Research Recruiting
Nashville, Tennessee, United States, 37203
Contact: Investigative Site    615-284-2310      
Sponsors and Collaborators
Faeth Therapeutics
Investigators
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Principal Investigator: Andrea Cerceck, MD Memorial Sloan Kettering Cancer Center
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Responsible Party: Faeth Therapeutics
ClinicalTrials.gov Identifier: NCT05183295    
Other Study ID Numbers: NEAAR-002
First Posted: January 10, 2022    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases