NBT-NM108 for Colon Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Trinitas Hospital and Comprehensive Cancer Center, Elizabeth, NJColon Cancer+4 MoreNBT-NM108 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether a high dietary fiber formula can reduce chemotherapy-induced diarrhea in patients with metastatic colon cancer.

Eligible Conditions
  • Stage IV Colon Cancer
  • Stage IVA Colon Cancer
  • Colon Cancer
  • Stage IVB Colon Cancer
  • Stage IVC Colon Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: Two weeks

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
Week 4
Tumor Response by RECIST v1.1 Criteria
Two weeks
To Measure Microbiome Health

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

No Microbiome Support
1 of 2
NM108 Drinks
1 of 2

Active Control

Experimental Treatment

42 Total Participants · 2 Treatment Groups

Primary Treatment: NBT-NM108 · No Placebo Group · Phase 2

NM108 Drinks
Drug
Experimental Group · 1 Intervention: NBT-NM108 · Intervention Types: Drug
No Microbiome SupportNoIntervention Group · 1 Intervention: No Microbiome Support · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: two weeks

Who is running the clinical trial?

Howard S. Hochster, MDLead Sponsor
Howard S Hochster, MDPrincipal InvestigatorRutgers University
1 Previous Clinical Trials
16 Total Patients Enrolled
Howard Hochster, MDPrincipal InvestigatorRutgers University
2 Previous Clinical Trials
67 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

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Frequently Asked Questions

Is NBT-NM108 a danger to human health?

"While there is some evidence that NBT-NM108 is safe, as this is only a Phase 2 trial, the lack of data regarding efficacy gives it a safety score of 2." - Anonymous Online Contributor

Unverified Answer

Is this clinical trial taking place at several locations within the state?

"There are presently 10 sites where this study is being conducted. The locations are based in Elizabeth, Newark and Somerville along with other locations 10 other locations. If you participate in this trial, it is important to select the clinic closest to your residence to minimize travel requirements." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies in this research project for participants?

"Based on the information available from clinicaltrials.gov, it does appear that this trial is still looking for participants. The study was initially posted on May 3rd, 2022 and was edited as recently as October 17th of the same year. There are currently 10 active recruiting sites and the goal is to have 42 patients total enrolled in the trial." - Anonymous Online Contributor

Unverified Answer

How many people are being included in this trial?

"The clinical trial is currently looking for participants, with the most recent edit on 10/17/2022. The study was originally posted on 5/3/2022 and is searching for 42 patients between 10 sites." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.