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NCT04750928 · ClinicalTrials.gov registry record · Phase 1
Cyclin-Dependent Kinase (CDK)4/6 Inhibitor Abemaciclib for Neurofibromatosis Type I (NF1) Related Atypical Neurofibromas
A Phase 1 study of Neurofibromatosis 1, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT04750928 is a Phase 1 study of Neurofibromatosis 1 that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 55 participants, below the 1,033-participant average among 24 other Neurofibromatosis 1 trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04750928, a Phase 1 study of Neurofibromatosis 1, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: NF1 is a genetic disease that causes tumors called atypical neurofibromas. These tumors, which arise from nerves, can cause serious medical problems. The only treatment is surgery. Researchers want to see if a drug called abemaciclib can help. Objective: To find a safe, tolerable dose of abemaciclib for treating atypical neurofibromas. Eligibility: People ages 12 and older who have NF1 and have one or more atypical neurofibromas that cannot or will not be removed with surgery Design: Participants will be screened with: Medical history and physical exam Blood, urine, and heart tests MRI: Participants will lie in a machine that takes pictures of the body. A padding or coil will be placed around their head. They may have a contrast agent injected into a vein. Biopsy sample: A small piece of tumor will be removed using a large needle. Participants will have frequent visits during the study. These will include repeats of the screening tests as well as the following: PET scan: Participants will lie in a machine that takes pictures of the body. They will have a contrast agent injected into their arm. Questionnaires about the effects of abemaciclib on pain and quality of life Possible photographs of tumors Participants will take abemaciclib capsules orally twice daily in 28-day cycles. They will take the drug for up to 2 years. Some may be able to take it for longer. Participants will have a follow-up visit about 30 days after their last dose of the study drug. Then they will have visits every 3 months for 1 year.
Conditions Studied
Interventions
- DRUG Abemaciclib
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2021-11-29 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04750928
The ClinicalTrials.gov registry entry for NCT04750928 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,033-participant average among 24 other Neurofibromatosis 1 trials with a reported enrollment target (95% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Neurofibromatosis 1 appearing as the primary indexed condition, and to 1 intervention - of which Abemaciclib is the first listed.
NCT04750928 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT04750928 about?
NCT04750928 is a clinical study titled "Cyclin-Dependent Kinase (CDK)4/6 Inhibitor Abemaciclib for Neurofibromatosis Type I (NF1) Related Atypical Neurofibromas". Background: NF1 is a genetic disease that causes tumors called atypical neurofibromas. These tumors, which arise from nerves, can cause serious medical problems. The only treatment is surgery. Researchers want to see if a drug called abemaciclib can help. Objective: To find a safe, tolerable dose...
What is the current status of trial NCT04750928?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2021-11-29. Estimated completion is 2029-12-31.
What conditions does trial NCT04750928 study?
This clinical trial studies the following conditions: Neurofibromatosis 1.
What interventions are being tested in trial NCT04750928?
The interventions under investigation include: Abemaciclib (DRUG).
Who is sponsoring clinical trial NCT04750928?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04750928 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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