Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery

Phase 2

Recruiting

• Conditions: Metastatic Colon Carcinoma; Stage IVA Colon Cancer AJCC v8; Stage IVB Colon Cancer AJCC v8; Stage IV Colon Cancer AJCC v8; Stage IVC Colon Cancer AJCC v8
• Interventions: Drug: NBT-NM108

• Registration Number: NCT05296681
• Lead Sponsor: Howard S. Hochster, MD

Brief Summary

This phase II trial tests whether NBT-NM108 works in reducing chemotherapy-induced diarrhea in patients with colon cancer that has spread to other places in the body (metastatic). Irinotecan is one of the most used medicine for colon cancer, but it leads to diarrhea in most patients receiving it and among some of them, severe diarrhea can occur. NBT-NM108 is a high dietary fiber formula that is developed based on research findings that have shown that high fiber diets can help maintain healthy bacteria in the gut and improve gut function. Giving NBT-NM108 to patients with colon cancer receiving chemotherapy may help relieve or lessen diarrhea symptoms and lead to improved tolerance of the chemotherapy drug, irinotecan.

Detailed Description

PRIMARY ENDPOINT:

Dose Intensity of Irinotecan administered (mg/m2/week)

SECONDARY ENDPOINTS:

1. Reduction in % Patients Needing Dose Modification for Diarrhea

2. Toxicity Grade of diarrhea

3. Response Rate

4. Time to Progression-free survival

EXPLORATORY ENDPOINTS:

1. 16S rRNA gene sequencing to reveal changes of the gut microbiota including institution of foundation guilds and restoration of healthy microbiome

2. Short chain fatty acids analysis (promotion of acetic and butyric acid production)

3. Markers for gut inflammation such as fecal lipocalin 2

4. Gut barrier function test to see if the restoration of healthier gut microbiota would improve gut barrier function.

Study Timeline

• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-16
• Study First Posted: 2022-03-25
• Study Start: 2022-05-03
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-21
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NM108 Drinks	NBT-NM108	NBT-NM108 Drinks four times daily before meals and 2 hours after dinner for 56 days. Beginning 5 days before starting chemotherapy, patients receive NBT-NM108 PO QID for 56 days. Patients receive irinotecan-based chemotherapy per standard of care.

Primary Outcome Measures

Name	Time	Method
Tumor Response by RECIST v1.1 Criteria	Imaging for response assessment will be obtained before the initiation of conditioning (no more than 4 weeks prior to apheresis) and at the 6-week follow up time point	Response and progression will be evaluated in this study using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used for tumor measurements
The number of participants with treatment-related Adverse Events as Assessed by Cancer Therapy Evaluation Program Common Toxicity Criteria (CTCAE) Version 5.0 for toxicity and Adverse Event reporting	Eight weeks	The number of participants with treatment-related Adverse Events as Assessed by Cancer Therapy Evaluation Program Common Toxicity Criteria (CTCAE) Version 5.0 for toxicity and Adverse Event reporting. Dose reduction should occur for CTCAE grade 3 or higher toxicity given maximum antidiarrheal support with Imodium and/or Lomotil.

Trial Locations

Locations (10)

The Cancer Center; 🇺🇸 Newark, New Jersey, United States

Robert Wood Johnson University Hospital; 🇺🇸 New Brunswick, New Jersey, United States

Robert Wood Johnson University Hospital, Somerset; 🇺🇸 Somerville, New Jersey, United States

Robert Wood Johnson University Hospital, Hamilton; 🇺🇸 Hamilton, New Jersey, United States

Monmouth Medical Center; 🇺🇸 Lakewood, New Jersey, United States

Cooperman Barnabas Medical Center; 🇺🇸 Livingston, New Jersey, United States

Rutgers Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States

Newark Beth Israel Medical Center; 🇺🇸 Newark, New Jersey, United States

Community Medical Center; 🇺🇸 Toms River, New Jersey, United States

RWJBarnabas Health - Monmouth Medical Center Southern Campus; 🇺🇸 Lakewood, New Jersey, United States