Study of Miransertib (MK-7075) in Participants With PIK3CA-related Overgrowth Spectrum and Proteus Syndrome (MOSAIC) (MK-7075-002) (MOSAIC)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03094832 |
Recruitment Status :
Terminated
(This study did not meet the efficacy objective)
First Posted : March 29, 2017
Last Update Posted : May 16, 2022
|
Sponsor:
ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
Collaborator:
Worldwide Clinical Trials
Information provided by (Responsible Party):
ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
Tracking Information | |||||||
---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | March 17, 2017 | ||||||
First Posted Date ICMJE | March 29, 2017 | ||||||
Last Update Posted Date | May 16, 2022 | ||||||
Actual Study Start Date ICMJE | May 16, 2017 | ||||||
Actual Primary Completion Date | April 11, 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
|
||||||
Original Primary Outcome Measures ICMJE |
Incidence of adverse events graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) guidelines, version 4.03 [ Time Frame: Up to 84 weeks ] The incidence of adverse events will be assessed as a measure of the safety and tolerability profile of ARQ 092
|
||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE |
|
||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Study of Miransertib (MK-7075) in Participants With PIK3CA-related Overgrowth Spectrum and Proteus Syndrome (MOSAIC) (MK-7075-002) | ||||||
Official Title ICMJE | A Phase 1/2 Study of ARQ 092 (Miransertib) in Subjects With PIK3CA-related Overgrowth Spectrum (PROS) and Proteus Syndrome (PS) (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 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. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 Phase 2 |
||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||
Condition ICMJE | PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome | ||||||
Intervention ICMJE | Drug: Miransertib
Miransertib capsules administered orally either 1 hour before or 2 hours after a meal
Other Names:
|
||||||
Study Arms ICMJE |
|
||||||
Publications * | Forde K, Resta N, Ranieri C, Rea D, Kubassova O, Hinton M, Andrews KA, Semple R, Irvine AD, Dvorakova V. Clinical experience with the AKT1 inhibitor miransertib in two children with PIK3CA-related overgrowth syndrome. Orphanet J Rare Dis. 2021 Feb 27;16(1):109. doi: 10.1186/s13023-021-01745-0. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Terminated | ||||||
Actual Enrollment ICMJE |
50 | ||||||
Original Estimated Enrollment ICMJE |
16 | ||||||
Actual Study Completion Date ICMJE | April 11, 2022 | ||||||
Actual Primary Completion Date | April 11, 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria: Part A
Part B:
Cohort 1 (PROS) specific criteria
Exclusion Criteria Part A:
Part B
|
||||||
Sex/Gender ICMJE |
|
||||||
Ages ICMJE | 2 Years and older (Child, Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Australia, Italy, Spain, United States | ||||||
Removed Location Countries | Brazil, Chile, France, Germany, Peru, United Kingdom | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03094832 | ||||||
Other Study ID Numbers ICMJE | 7075-002 MOSAIC ( Other Identifier: ArQule ) ARQ 092-103 ( Other Identifier: ArQule ) MK-7075-002 ( Other Identifier: Merck ) 2016-000558-37 ( EudraCT Number ) |
||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
|
||||||
IPD Sharing Statement ICMJE |
|
||||||
Current Responsible Party | ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Worldwide Clinical Trials | ||||||
Investigators ICMJE |
|
||||||
PRS Account | ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) | ||||||
Verification Date | May 2022 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |