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Antibiotic
Treatment (novobiocin sodium) for Solid Tumors
Phase 1
Recruiting
Led By Geoffrey I Shapiro
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial tests a drug to shrink or stabilize cancer caused by a mutation in DNA repair genes. It blocks the activity of a protein to help repair damaged DNA.
Who is the study for?
This trial is for adults with advanced or inoperable tumors that have specific mutations in DNA repair genes. Patients must have tried other treatments without success and may or may not have used PARP inhibitors, depending on the type of cancer. They should be relatively healthy otherwise, with adequate blood cell counts and organ function.Check my eligibility
What is being tested?
The trial is testing Novobiocin Sodium's safety and optimal dosage. It's an antibiotic thought to kill cancer cells by blocking a protein involved in DNA repair. The study includes biopsies, biospecimen collection, and diagnostic imaging to monitor effects.See study design
What are the potential side effects?
While the side effects of Novobiocin are being studied here, potential risks might include typical drug reactions like nausea, allergic responses, changes in blood pressure or heart rate, liver toxicity, fatigue or discomfort at injection sites.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) and recommended phase 2 dose of continuous novobiocin administration
Secondary outcome measures
Biological effectiveness
Plasma concentrations of novobiocin
Other outcome measures
ATM immunohistochemistry (IHC)
POLQ messenger ribonucleic acid level (mRNA)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (novobiocin sodium)Experimental Treatment4 Interventions
Patients receive novobiocin sodium PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a tumor biopsy at baseline, on day 15 of cycle 1, and at time of progression. Patients undergo medical imaging scans at baseline and every 8 weeks. Patients also undergo blood sample collection on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1720
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,334 Total Patients Enrolled
Geoffrey I ShapiroPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
3 Previous Clinical Trials
317 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Treatment (novobiocin sodium)
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.
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