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NCT02594215 · ClinicalTrials.gov registry record · Phase 1
Dose Finding Trial of MK-7075 in Children and Adults With Proteus Syndrome
A Phase 1 study, sponsored by National Human Genome Research Institute (NHGRI).
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT02594215 is a Phase 1 study that has completed, run by National Human Genome Research Institute (NHGRI). The registered enrollment target is 6 participants.
The verdict
NCT02594215, a Phase 1 study, has completed, sponsored by National Human Genome Research Institute (NHGRI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
Background: Proteus syndrome (PS) is caused by a mutation in the AKT1 gene. This gene makes a protein that communicates with other proteins in the body to make cells grow. The AKT1 mutation changes chemical signals in the body and causes overgrowth. PS can be fatal. The drug MK-7075 reduces signals from the AKT1 protein. This may reduce or stabilize some of the overgrowth in people with PS. Researchers want to find the best dose of MK-7075 based on its effect on tissues in people with PS. Objective: To determine the safety, tolerability, and recommended dose of MK-7075 in people with PS. Eligibility: People ages 6 and older with PS Design: Participants will be screened with medical history, physical exam, and blood and urine tests. Participants will take MK-7075 by mouth once daily for up to 12 28-day cycles. Participants must stay near the NIH Clinical Center (CC) during the whole first cycle, for weekly visits to the CC. For cycle 2, they will have visits every 2 weeks. They will have 1 visit before cycles 3 and 4, and once before every other cycle for cycles 5 11. The final visit will be at the end of cycle 12. Visits may include: Small skin samples taken. ECG: Soft electrodes on the skin record heart signals. Echocardiogram: A small probe held to the chest takes pictures of the heart. MRI: Participants will lie in a machine that takes pictures of the body. Joint and mobility function tests. Participants will complete surveys by phone and in person. Participants will keep a daily medication and symptom diary. ...
Interventions
- DRUG MK-7075 (miransertib)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2015-11-16 |
| Est. Completion | 2022-06-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02594215
The ClinicalTrials.gov registry entry for NCT02594215 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Human Genome Research Institute (NHGRI), which has 185 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which MK-7075 (miransertib) is the first listed.
NCT02594215 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02594215 about?
NCT02594215 is a clinical study titled "Dose Finding Trial of MK-7075 in Children and Adults With Proteus Syndrome". Background: Proteus syndrome (PS) is caused by a mutation in the AKT1 gene. This gene makes a protein that communicates with other proteins in the body to make cells grow. The AKT1 mutation changes chemical signals in the body and causes overgrowth. PS can be fatal. The drug MK-7075 reduces signals...
What is the current status of trial NCT02594215?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2015-11-16. Estimated completion is 2022-06-24.
What interventions are being tested in trial NCT02594215?
The interventions under investigation include: MK-7075 (miransertib) (DRUG).
Who is sponsoring clinical trial NCT02594215?
This trial is sponsored by National Human Genome Research Institute (NHGRI), which has 185 total clinical trials registered on ClinicalTrials.gov.
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