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NCT05687110 · ClinicalTrials.gov registry record · Phase 1
Studying the Safety and Determining the Optimal Dose of Novobiocin in Patients With Tumors That Have Alterations in DNA Repair Genes
A Phase 1 study of Metastatic Malignant Solid Neoplasm and Unresectable Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
- 20
- Study locations
NCT05687110: Recruiting Phase 1 study of Metastatic Malignant Solid Neoplasm and Unresectable Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
NCT05687110 is a Phase 1 study of Metastatic Malignant Solid Neoplasm and Unresectable Malignant Solid Neoplasm that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 43 participants, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05687110, a Phase 1 study of Metastatic Malignant Solid Neoplasm and Unresectable Malignant Solid Neoplasm, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase I trial tests the safety, side effects, and best dose of novobiocin in treating cancer patients with alterations in deoxyribonucleic acid (DNA) repair genes. Novobiocin is an antibiotic that blocks the activity of a protein called DNA polymerase theta, which helps repair DNA that has become damaged as cells grow and divide. Cancer cells that cannot repair their damaged DNA die. This medication may help shrink or stabilize cancer with a mutation in DNA repair genes.
Primary Outcome
The MTD will be identified as the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate. Standard hematological and non-hematologic parameters, scored using Common Terminology Criteria for Adverse Events version 5.0, will be used to define dose limiting toxicity.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Biopsy Procedure
- PROCEDURE Diagnostic Imaging Testing
- BIOLOGICAL Novobiocin Sodium
Study Locations (20)
California
- City of Hope Comprehensive Cancer Center - Duarte
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- UC San Diego Moores Cancer Center - La Jolla
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- University of California Davis Comprehensive Cancer Center - Sacramento
- UC San Diego Medical Center - Hillcrest - San Diego
Maryland
- National Cancer Institute Developmental Therapeutics Clinic - Bethesda
- National Institutes of Health Clinical Center - Bethesda
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
New York
- NYU Langone Hospital - Long Island - Mineola
- Laura and Isaac Perlmutter Cancer Center at NYU Langone - New York
Washington
- Fred Hutchinson Cancer Center - Seattle
- University of Washington Medical Center - Montlake - Seattle
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2023-07-06 |
| Est. Completion | 2026-09-01 |
| Phase | Phase 1 |
What NCT05687110 shows while recruiting
NCT05687110 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (79% lower).
The record links to 2 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT05687110 names 20 study sites across 9 states, led by California, Maryland, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05687110 about?
NCT05687110 is a clinical study titled "Studying the Safety and Determining the Optimal Dose of Novobiocin in Patients With Tumors That Have Alterations in DNA Repair Genes". This phase I trial tests the safety, side effects, and best dose of novobiocin in treating cancer patients with alterations in deoxyribonucleic acid (DNA) repair genes. Novobiocin is an antibiotic that blocks the activity of a protein called DNA polymerase theta, which helps repair DNA that has beco...
What is the current status of trial NCT05687110?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2023-07-06. Estimated completion is 2026-09-01.
What conditions does trial NCT05687110 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm.
What interventions are being tested in trial NCT05687110?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Biopsy Procedure (PROCEDURE), Diagnostic Imaging Testing (PROCEDURE), Novobiocin Sodium (BIOLOGICAL).
Who is sponsoring clinical trial NCT05687110?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05687110 being conducted?
This trial has 20 study locations across California, Illinois, Maryland, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05687110's enrollment target sits among peer trials
43 60th of 92 higher than 32 of 92 other Metastatic Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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