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Study of Miransertib (MK-7075) in Participants With PIK3CA-related Overgrowth Spectrum and Proteus Syndrome (MOSAIC) (MK-7075-002)

NCT03094832 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-04-13

Study results available
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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).

Conditions

  • PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome

Interventions

DRUG

Miransertib

Miransertib capsules administered orally at an initial dose of 15 mg/m\^2 or 25 mg/m\^2 QD and then titrated up to 25 mg/m\^2 or 35 mg/m\^2 QD at the investigator's discretion.

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER

  • ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-16
Primary Completion
2022-04-11
Completion
2022-04-11
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03094832 on ClinicalTrials.gov