Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery
Recruiting
Phase 2
Interventional Study
Metastatic Colon Carcinoma
Stage IV Colon Cancer AJCC v8
Stage IVA Colon Cancer AJCC v8
Stage IVB Colon Cancer AJCC v8
Stage IVC Colon Cancer AJCC v8
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 42 (estimated)
- Sponsor
- Howard S. Hochster, MD · Other
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About This Trial
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 de…
Trial Locations
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Eligibility Criteria
Inclusion Criteria
* Biopsy proven and metastatic colon cancer
* Candidate for Second-line or later line therapy with irinotecan-based chemotherapy regimen with starting dose of irinotecan at 180 mg/m2 q2w.
Participants who have had prior irinotecan will be eligible if they are off irinotecan for …
Contacts