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Antibiotic

Treatment (novobiocin sodium) for Solid Tumors

Phase 1

Waitlist Available

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.

Eligible Conditions

Cancer
Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

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

~850

Biospecimen Collection

2004

Completed Phase 2

~1730

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,655 Previous Clinical Trials

40,933,189 Total Patients Enrolled

Geoffrey I ShapiroPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO

3 Previous Clinical Trials

317 Total Patients Enrolled

Media Library

Novobiocin Sodium (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05687110 — Phase 1

Solid Tumors Research Study Groups: Treatment (novobiocin sodium)

Solid Tumors Clinical Trial 2023: Novobiocin Sodium Highlights & Side Effects. Trial Name: NCT05687110 — Phase 1

Novobiocin Sodium (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05687110 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor seeking out participants?

"Affirmative. The clinicaltrials.gov website attests to this medical experiment being actively enrolled with recruitment beginning on April 14th 2023 and the posting updated as recently as April 29th 2023 for 30 participants from one site."

Answered by AI

Has novobiocin sodium been sanctioned by the FDA?

"Given the limited amount of supporting data, Treatment (novobiocin sodium) was given a safety rating of 1. This is due to it being a Phase 1 trial and having just minimal evidence regarding efficacy and security."

Answered by AI

How many participants have been recruited for this clinical experiment?

"Affirmative. According to the data hosted on clinicaltrials.gov, recruitment for this trial is still in progress. The initial posting date was April 14th 2023 and it has been recently updated as of April 29th 2023. 30 participants will be recruited from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Studying the Safety and Determining the Optimal Dose of Novobiocin in Patients With Tumors That Have Alterations in DNA Repair Genes

2023. "Studying the Safety and Determining the Optimal Dose of Novobiocin in Patients With Tumors That Have Alterations in DNA Repair Genes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05687110.