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PI3K Inhibitor

Miransertib for Proteus Syndrome

Phase 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has PROS or PS and is currently being actively treated with miransertib as part of Study MK-7075-002 (NCT03094832) or ArQule's Compassionate Use and Extended Access Program (CU/EAP, NCT03317366)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 4 years
Awards & highlights

Study Summary

This trial is studying the safety of a drug called miransertib in children with a genetic condition called PIK3CA-related overgrowth spectrum (PROS) or Proteus syndrome (PS).

Who is the study for?
This trial is for people at least 2 years old with PROS or Proteus Syndrome who are already taking Miransertib in other studies. It's not open to those on mTOR inhibitors like sirolimus, high dose steroids, immunosuppressives, or anyone who stopped Miransertib due to severe side effects.Check my eligibility
What is being tested?
The study tests the safety and tolerability of an oral drug called Miransertib (MK-7075) for patients with PIK3CA-related overgrowth spectrum or Proteus Syndrome. This extends previous trials and includes new participants approved but not yet started on treatment.See study design
What are the potential side effects?
While specific side effects aren't listed here, the exclusion criteria suggest that past serious adverse events (SAEs) related to Miransertib could be a concern. Typically, such drugs may cause issues ranging from mild discomforts to more significant organ-specific reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently being treated with miransertib for PROS or PS as part of a specific study or program.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants discontinuing study treatment due to an Adverse Event (AE)
Number of participants experiencing a Serious Adverse Event (SAE)

Trial Design

1Treatment groups
Experimental Treatment
Group I: MiransertibExperimental Treatment1 Intervention
Participants with either PROS or PS receive miransertib orally once daily between 5 and 35 mg/m^2 based on prior approved dosing for up to 48 cycles. A cycle is 28 days long.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,762 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,883 Previous Clinical Trials
5,053,876 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,774 Previous Clinical Trials
8,062,907 Total Patients Enrolled
1 Trials studying Proteus Syndrome
50 Patients Enrolled for Proteus Syndrome

Media Library

Miransertib (PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04980872 — Phase 2
Proteus Syndrome Research Study Groups: Miransertib
Proteus Syndrome Clinical Trial 2023: Miransertib Highlights & Side Effects. Trial Name: NCT04980872 — Phase 2
Miransertib (PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04980872 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently opportunities for participants to join this experiment?

"According to clinicaltrials.gov, this medical study is not presently looking for participants; its first posting was on November 2nd 2021 and it last updated 11th August 2022. Though the trial has closed recruitment, there are still 1383 other studies actively enrolling patients at this time."

Answered by AI

Is Miransertib a relatively novel or well-researched therapeutic?

"At the present moment, only two clinical trials are actively researching miransertib and neither is in Phase 3. Bethesda, Maryland hosts the most number of studies for this medication; however 12 locations across the country have begun investigations involving it."

Answered by AI

Is there an opportunity for me to participate in this investigation?

"This medical trial is accepting participants aged between 2 and 120 with the specified syndrome. A total of 60 individuals will be enrolled in the experiment."

Answered by AI

Is this trial unique in terms of its research objectives?

"Merck Sharp & Dohme Corp. first studied Miransertib in 2021, wherein 60 participants were involved. Based on the results of this initial research, Phase 2 drug approval was granted to Miransertib. Currently two studies are being conducted across 12 cities and 5 countries regarding the efficacy of this medication."

Answered by AI

Does this research venture encompass participants aged 70 and above?

"This clinical trial has an expansive eligibility pool, with applicants aged 2 to 120 welcome. There are 374 trials for minors and 984 studies suitable for seniors."

Answered by AI

Has Miransertib been sanctioned by the FDA?

"Our team at Power rated the safety of Miransertib a 2, given that this is in its second phase of clinical trials and while there are some data points confirming safety, none verify efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of the Safety and Tolerability in Participants With PIK3CA-related Overgrowth Spectrum or Proteus Syndrome Who Are Being Treated With Miransertib (MK-7075) in Other Studies (MK-7075-006)
2021. "A Study of the Safety and Tolerability in Participants With PIK3CA-related Overgrowth Spectrum or Proteus Syndrome Who Are Being Treated With Miransertib (MK-7075) in Other Studies (MK-7075-006)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04980872.
~30 spots leftby Sep 2026
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