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AKT Inhibitor

MK-7075 (miransertib) for Proteus Syndrome

Phase 1
Waitlist Available
Led By Leslie G Biesecker, M.D.
Research Sponsored by National Human Genome Research Institute (NHGRI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ongoing
Awards & highlights

Study Summary

NCT02594215

Eligible Conditions
  • Proteus Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of cycle 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of cycle 3 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tissue drug levels
Tissue phospho-AKT level
Tolerabilty/Side Effects
Secondary outcome measures
Tolerability and side effects

Trial Design

1Treatment groups
Experimental Treatment
Group I: ExperimentalExperimental Treatment1 Intervention
Experimental
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-7075 (miransertib)
2015
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

National Human Genome Research Institute (NHGRI)Lead Sponsor
263 Previous Clinical Trials
284,126 Total Patients Enrolled
3 Trials studying Proteus Syndrome
1,575 Patients Enrolled for Proteus Syndrome
Leslie G Biesecker, M.D.Principal InvestigatorNational Human Genome Research Institute (NHGRI)
9 Previous Clinical Trials
12,452 Total Patients Enrolled
2 Trials studying Proteus Syndrome
1,545 Patients Enrolled for Proteus Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
The American Journal of Human GeneticsJournal
Pharmacodynamic Study of Miransertib in Individuals with Proteus Syndrome
Keppler-Noreuil, Kim M., Julie C. Sapp, Marjorie J. Lindhurst, Thomas N. Darling, Jasmine Burton-Akright, Mohammadhadi Bagheri, Eva Dombi, et al.. 2019. “Pharmacodynamic Study of Miransertib in Individuals with Proteus Syndrome”. The American Journal of Human Genetics. Elsevier BV. doi:10.1016/j.ajhg.2019.01.015.
Molecular Case StudiesJournal
Case Report: Five-year Experience of AKT Inhibition with Miransertib (MK-7075) in an Individual with Proteus Syndrome
Ours, Christopher A., Julie C. Sapp, Mia B. Hodges, Allison J. de Moya, and Leslie G. Biesecker. 2021. “Case Report: Five-year Experience of AKT Inhibition with Miransertib (MK-7075) in an Individual with Proteus Syndrome”. Molecular Case Studies. Cold Spring Harbor Laboratory. doi:10.1101/mcs.a006134.
clinicaltrials.govStudy
Dose Finding Trial of MK-7075 in Children and Adults With Proteus Syndrome
2015. "Dose Finding Trial of MK-7075 in Children and Adults With Proteus Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02594215.
~1 spots leftby Apr 2025
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