Clinical Trials in Italy / NCT04980872
Active, not recruiting
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)
NCT04980872 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome (PS)
Investigational drug(s) / intervention(s)
Miransertib
Miransertib: Miransertib capsules administered orally either 1 hour before or 2 hours after a meal.
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.
Eligibility
Inclusion Criteria:
* Has PROS or PS and has been screened in Study MK-7075-002 (or has been approved by the Sponsor to screen for MK-7075-002) or is currently being treated with miransertib as part of Study MK-7075-002 (NCT03094832) or ArQule's CU/EAP (NCT03317366)
* For males, agrees to be abstinent from heterosexual intercourse or use contraception unless confirmed to be azoospermic during the study period and for ≥90 days after the last dose of study intervention
* For females, is not pregnant or breastfeeding, and is either not a participant of childbearing potential (POCBP) or is a POCBP and is abstinent or uses a highly effective method of contraception
Exclusion Criteria:
* Has previously discontinued miransertib due to related SAEs or other intolerance of miransertib
* Has received other investigational agents, if any, that were administered between leaving Study MK-7075-02 or ArQule's CU/EAP and entering this trial
* Is receiving systemic inhibitors of the mechanistic target of rapamycin (mTOR) pathway (eg, sirolimus, everolimus)
* Is receiving immunosuppressive therapies
* Is receiving continuous high dose steroids
Primary outcome measure(s)
- Number of participants experiencing a Serious Adverse Event (SAE) — Up to approximately 94 months
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. - Number of participants discontinuing study treatment due to an Adverse Event (AE) — Up to approximately 90 months
An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product and does not imply any judgment about causality.
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| Children's Healthcare of Atlanta - Egleston Hospital ( Site 0107) | Atlanta | Georgia | |
| Boston Children's Hospital ( Site 0089) | Boston | Massachusetts | |
| Cincinnati Children's Hospital Medical Center-Hematology ( Site 0102) | Cincinnati | Ohio | |
| Texas Children's Hospital ( Site 0104) | Houston | Texas | |
| Seattle Children's Hospital ( Site 0103) | Seattle | Washington | |
| John Hunter Hospital ( Site 0203) | Newcastle | New South Wales | |
| Bundaberg Base Hospital ( Site 0202) | Bundaberg | Queensland | |
| Hospital Araújo Jorge ( Site 0801) | Goiânia | Goiás | |
| Fondazione Policlinico Universitario Agostino Gemelli ( Site 0052) | Rome | Lazio | |
| Ospedale Pediatrico Bambino Gesù-Centro Trials ( Site 0087) | Rome | Roma | |
| Great Ormond Street Hospital ( Site 0701) | London | London, City of |
More Merck Sharp & Dohme LLC trials in Italy
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04980872 on ClinicalTrials.gov ↗ ← All trials in Italy