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NCT04980872 · ClinicalTrials.gov registry record · Phase 2
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)
A Phase 2 study of PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome (PS), sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 11
- Study locations
NCT04980872: Active Phase 2 study of PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome (PS), sponsored by Merck Sharp & Dohme.
NCT04980872 is a Phase 2 study of PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome (PS) that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). The trial reports 11 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04980872, a Phase 2 study of PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome (PS), is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 11
- Study locations
Study Summary
This is a study of the safety and tolerability of oral miransertib (MK-7075) administered to participants at least 2 years of age with phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-related overgrowth spectrum (PROS) or Proteus Syndrome (PS). This is an extension of other miransertib studies (MK-7075-002 \[NCT03094832\] or ArQule CU/EAP \[NCT03317366\]), and may also enroll participants who are approved for MK-7075-002 but have not yet started miransertib therapy.
Primary Outcome
An SAE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An SAE can therefore be any such event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalizations, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is considered by the investigator to be an important medical event.
Conditions Studied
Interventions
- DRUG Miransertib
Study Locations (11)
Georgia
- Children's Healthcare of Atlanta - Egleston Hospital ( Site 0107) - Atlanta
Massachusetts
- Boston Children's Hospital ( Site 0089) - Boston
Ohio
- Cincinnati Children's Hospital Medical Center-Hematology ( Site 0102) - Cincinnati
Texas
- Texas Children's Hospital ( Site 0104) - Houston
Washington
- Seattle Children's Hospital ( Site 0103) - Seattle
New South Wales
- John Hunter Hospital ( Site 0203) - Newcastle
Queensland
- Bundaberg Base Hospital ( Site 0202) - Bundaberg
Goiás
- Hospital Araújo Jorge ( Site 0801) - Goiânia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-11-02 |
| Est. Completion | 2030-02-07 |
| Phase | Phase 2 |
What the registry record for NCT04980872 still lists
NCT04980872 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 1 condition, with PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome (PS) appearing as the primary indexed condition, and to 1 intervention - of which Miransertib is the first listed.
NCT04980872 lists 11 locations in 11 states (Georgia, Massachusetts, Ohio).
Frequently Asked Questions
What is clinical trial NCT04980872 about?
NCT04980872 is a clinical study titled "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)". This is a study of the safety and tolerability of oral miransertib (MK-7075) administered to participants at least 2 years of age with phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-related overgrowth spectrum (PROS) or Proteus Syndrome (PS). This is an extension of ...
What is the current status of trial NCT04980872?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2021-11-02. Estimated completion is 2030-02-07.
What conditions does trial NCT04980872 study?
This clinical trial studies the following conditions: PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome (PS).
What interventions are being tested in trial NCT04980872?
The interventions under investigation include: Miransertib (DRUG).
Who is sponsoring clinical trial NCT04980872?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04980872 being conducted?
This trial has 11 study locations across Georgia, Massachusetts, Ohio, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04980872's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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