Ignite Creation Date:
2025-12-24 @ 9:35 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT03094832
Status:
TERMINATED
Last Update Posted:
2023-04-13
First Post:
2017-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Miransertib (MK-7075) in Participants With PIK3CA-related Overgrowth Spectrum and Proteus Syndrome (MOSAIC) (MK-7075-002)
Sponsor:
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Organization:
Study Overview
Official Title:
A Phase 1/2 Study of ARQ 092 (Miransertib) in Subjects With PIK3CA-related Overgrowth Spectrum and Proteus Syndrome
Status:
TERMINATED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Early termination due to business reasons
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03317366
Has Expanded Access, NCT# Status:
NO_LONGER_AVAILABLE
Acronym:
MOSAIC
Brief 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).
Detailed Description:
The study consists of two parts: Part A and Part B. Part A was closed to enrollment under Amendment 6. As of Amendment 7, the endpoints for Part A and Part B have been combined to assess the safety and tolerability of miransertib in participants with PROS and PS. Previous efficacy and pharmacokinetic (PK) objectives and endpoints have been removed. Amendment 7 will complete the final enrollment into the MOSAIC study and Compassionate Use/Expanded Access Program.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: