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Anti-tumor antibiotic
NB1011 for Colorectal Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by NewBiotics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prior treatment with irinotecan with or without fluorouracil
Uni-dimensionally measurable disease allowed provided CEA is at least 2 times the upper limit of normal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying how well NB1011 works in treating patients with metastatic or recurrent colorectal cancer.
Who is the study for?
This trial is for adults with metastatic or recurrent colorectal cancer that worsened after fluoropyrimidine-based therapy. They must have a life expectancy of at least 3 months, measurable disease, normal organ function tests, and no severe infections or other cancers in the last 2 years. Participants need to use contraception if fertile and cannot be pregnant, nursing, or HIV positive.Check my eligibility
What is being tested?
The trial is testing NB1011's effectiveness on patients with advanced colorectal cancer who haven't responded to previous treatments. It's a Phase I/II study which means they're looking at how safe it is (Phase I) and how well it works (Phase II).See study design
What are the potential side effects?
While specific side effects of NB1011 are not listed here, common chemotherapy-related side effects may include nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts, and potential liver or kidney issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been treated with irinotecan, with or without fluorouracil.
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My cancer can be measured in one dimension and my CEA levels are high.
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I am 18 years old or older.
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I am mostly able to care for myself and carry out daily activities.
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My kidney function is good, with creatinine below 1.5 mg/dL or clearance above 50 mL/min.
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I do not have any serious or uncontrolled infections.
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My liver function tests are within normal ranges.
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I am not allergic to NB1011 or its ingredients.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Find a Location
Who is running the clinical trial?
NewBioticsLead Sponsor
Mark D. Pegram, MDStudy ChairJonsson Comprehensive Cancer Center
7 Previous Clinical Trials
85 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not receiving any other cancer treatments.I am not taking disulfiram.My colorectal cancer has worsened during or within 6 months after treatment with fluoropyrimidine.I have been treated with irinotecan, with or without fluorouracil.My cancer can be measured in one dimension and my CEA levels are high.I am 18 years old or older.I am mostly able to care for myself and carry out daily activities.I haven't had any cancer in the last 2 years, except for certain skin cancers or cervical pre-cancer.My kidney function is good, with creatinine below 1.5 mg/dL or clearance above 50 mL/min.I have recovered from previous cancer radiation treatment and am not receiving it now, except for pain or fracture control.I have recovered from my last cancer chemotherapy and am not currently on drugs that target DNA synthesis.My treatment plan does not specify hormone therapy.My treatment plan does not specify biologic therapy.I do not have any serious or uncontrolled infections.I have fully recovered from any previous cancer surgery.My cancer has not spread to my brain or spinal cord.My liver function tests are within normal ranges.I am not allergic to NB1011 or its ingredients.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for enrolment in this clinical trial at present?
"Per the data provided on clinicaltrials.gov, this experiment is no longer recruiting patients - it was initially posted in December 2001 and last updated on December 2013. Despite not actively searching for participants any longer, there are 1064 other studies with open enrollment at present."
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