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)
NCT ID: NCT04980872
Last Updated: 2025-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2021-11-02
2030-02-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Miransertib
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 96 cycles. A cycle is 28 days long.
Miransertib
Miransertib capsules administered orally either 1 hour before or 2 hours after a meal.
Interventions
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Miransertib
Miransertib capsules administered orally either 1 hour before or 2 hours after a meal.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
2 Years
120 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Children's Healthcare of Atlanta - Egleston Hospital ( Site 0107)
Atlanta, Georgia, United States
Boston Children's Hospital ( Site 0089)
Boston, Massachusetts, United States
Cincinnati Children's Hospital Medical Center-Hematology ( Site 0102)
Cincinnati, Ohio, United States
Texas Children's Hospital ( Site 0104)
Houston, Texas, United States
Seattle Children's Hospital ( Site 0103)
Seattle, Washington, United States
John Hunter Hospital ( Site 0203)
Newcastle, New South Wales, Australia
Bundaberg Base Hospital ( Site 0202)
Bundaberg, Queensland, Australia
Hospital Araújo Jorge ( Site 0801)
Goiânia, Goiás, Brazil
Fondazione Policlinico Universitario Agostino Gemelli ( Site 0052)
Rome, Lazio, Italy
Ospedale Pediatrico Bambino Gesù-Centro Trials ( Site 0087)
Rome, Roma, Italy
Great Ormond Street Hospital ( Site 0701)
London, London, City of, United Kingdom
Countries
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Related Links
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Merck Oncology Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-7075-006
Identifier Type: OTHER
Identifier Source: secondary_id
2022-500689-87-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-001369-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
7075-006
Identifier Type: -
Identifier Source: org_study_id
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