Study of Miransertib (MK-7075) in Participants With PIK3CA-related Overgrowth Spectrum and Proteu… (NCT03094832) | Clinical Trial Compass
TerminatedPhase 1/2
Study of Miransertib (MK-7075) in Participants With PIK3CA-related Overgrowth Spectrum and Proteus Syndrome (MOSAIC) (MK-7075-002)
Stopped: Early termination due to business reasons
United States50 participantsStarted 2017-05-16
Plain-language summary
This is an open label, Phase 1/2 study 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) and Proteus Syndrome (PS) (MOSAIC).
Who can participate
Age range2 Years
SexALL
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Inclusion Criteria:
Part A
* Signed informed consent and, when applicable, signed assent
* Male or female participants ≥ 2 years old with body surface area (BSA) of ≥ 0.33 m\^2
* Have a clinical diagnosis of PROS or PS with documented somatic PIK3CA or serine-threonine protein kinase (AKT1) mutations
* Archival or fresh overgrowth tissue sample available to be shipped to Sponsor or designee
* Have poor prognosis, significant morbidity, and/or progressive disease (e.g., worsening of the disease/increase in number or size of the overgrowth lesions in the last 12 months)
* Have measurable disease (at least one overgrowth lesion that can be accurately measured in size by imaging and/or linear or circumference measure)
* Adequate organ function based on screening laboratory values
* If a female is of child-bearing potential, documentation of a negative pregnancy test is required prior to enrollment. Sexually active participants (male and female) must agree to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse while on study and for up to 90 days after ending treatment
* Ability to complete the Quality of Life (QoL) questionnaires by the participant or his/her caregiver
Part B:
* Signed consent form and when applicable, signed assent
* Archival or fresh overgrowth tissue sample available to be shipped to Sponsor or designee
* Except for Cohort 4, clinically progressive or worsening disease defined as an increase in number or size of the o…
What they're measuring
1
Number of Participants Who Experienced an Adverse Event (AE)
Timeframe: Up to approximately 48 months
2
Number of Participants Who Discontinued Study Treatment Due to an AE
Timeframe: Up to approximately 45 months
Trial details
NCT IDNCT03094832
SponsorArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)