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NCT05588141 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Study of Zotiraciclib for Recurrent Malignant Gliomas With Isocitrate Dehydrogenase 1 or 2 (IDH1 or IDH2) Mutations
A Phase 1 study of Cancer and Brain Tumor, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 96
- Enrollment target
- 1
- Study location
NCT05588141: Recruiting Phase 1 study of Cancer and Brain Tumor, sponsored by National Cancer Institute (NCI).
NCT05588141 is a Phase 1 study of Cancer and Brain Tumor that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 96 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05588141, a Phase 1 study of Cancer and Brain Tumor, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 96 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Diffuse gliomas are tumors that affect the brain and spinal cord. Gliomas that develop in people with certain gene mutations (IDH1 or IDH2) are especially aggressive. Better treatments are needed. Objective: To see if a study drug (zotiraciclib) is effective in people with recurrent diffuse gliomas who have IDH1 or IDH2 mutations. Eligibility: People aged 15 years and older with diffuse gliomas that returned after treatment. They must also have mutations in the IDH1 or IDH2 genes. Design: Participants will be screened. They will have a physical exam with blood and urine tests. They will have tests of their heart function. They will have an MRI of their brain. A new biopsy may be needed if previous results are not available. Zotiraciclib is a capsule taken by mouth with a glass of water. Participants will take the drug at home on days 1, 4, 8, 11, 15, and 18 of a 28-day cycle. They may also be given medications to prevent side effects of the study drug. The schedule for taking the study drug may vary for participants who will undergo surgery. Participants will be given a medication diary for each cycle. They will write down the date and time of each dose of the study drug. Participants will visit the clinic about once a month. They will have a physical exam, blood tests, and tests to evaluate their heart function. An MRI of the brain will be repeated every 8 weeks. Participants may remain in the study for up to 18 cycles (1.5 years).
Primary Outcome
Proportion of patients that have progressive disease after 12 months
Conditions Studied
Interventions
- DRUG Zotiraciclib
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2023-05-16 |
| Est. Completion | 2032-08-02 |
| Phase | Phase 1 |
What NCT05588141 shows while recruiting
NCT05588141 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Cancer appearing as the primary indexed condition, and to 1 intervention - of which Zotiraciclib is the first listed.
NCT05588141 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05588141 about?
NCT05588141 is a clinical study titled "A Phase I/II Study of Zotiraciclib for Recurrent Malignant Gliomas With Isocitrate Dehydrogenase 1 or 2 (IDH1 or IDH2) Mutations". Background: Diffuse gliomas are tumors that affect the brain and spinal cord. Gliomas that develop in people with certain gene mutations (IDH1 or IDH2) are especially aggressive. Better treatments are needed. Objective: To see if a study drug (zotiraciclib) is effective in people with recurrent d...
What is the current status of trial NCT05588141?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2023-05-16. Estimated completion is 2032-08-02.
What conditions does trial NCT05588141 study?
This clinical trial studies the following conditions: Cancer, Brain Tumor.
What interventions are being tested in trial NCT05588141?
The interventions under investigation include: Zotiraciclib (DRUG).
Who is sponsoring clinical trial NCT05588141?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05588141 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05588141's enrollment target sits among peer trials
96 332nd of 615 higher than 284 of 615 other Cancer trials
participants (enrollment target), bucketed by value
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