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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7075-006 | Other Identifier | MSD | |
| 2022-500689-87-00 | Registry Identifier | EU CT | |
| 2021-001369-19 | EudraCT Number |
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This is a study of the safety and tolerability 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) or Proteus Syndrome (PS). This is an extension of other miransertib studies (MK-7075-002 [NCT03094832] or ArQule CU/EAP [NCT03317366]), and may also enroll participants who are approved for MK-7075-002 but have not yet started miransertib therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Miransertib | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Miransertib | Drug | Miransertib capsules administered orally either 1 hour before or 2 hours after a meal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing a Serious Adverse Event (SAE) | An SAE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An SAE can therefore be any such event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalizations, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is considered by the investigator to be an important medical event. | Up to approximately 94 months |
| Number of participants discontinuing study treatment due to an Adverse Event (AE) | An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product and does not imply any judgment about causality. | Up to approximately 90 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Healthcare of Atlanta - Egleston Hospital ( Site 0107) | Atlanta | Georgia | 30322 | United States | ||
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| Label | URL |
|---|---|
| Merck Oncology Clinical Trials Information | View source |
| Plain Language Summary | View source |
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Multicenter
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None (Open-label)
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| Boston Children's Hospital ( Site 0089) |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Cincinnati Children's Hospital Medical Center-Hematology ( Site 0102) | Cincinnati | Ohio | 45229 | United States |
| Texas Children's Hospital ( Site 0104) | Houston | Texas | 77030 | United States |
| Seattle Children's Hospital ( Site 0103) | Seattle | Washington | 98105 | United States |
| John Hunter Hospital ( Site 0203) | Newcastle | New South Wales | 2305 | Australia |
| Bundaberg Base Hospital ( Site 0202) | Bundaberg | Queensland | 4670 | Australia |
| Hospital Araújo Jorge ( Site 0801) | Goiânia | Goiás | 74605070 | Brazil |
| Fondazione Policlinico Universitario Agostino Gemelli ( Site 0052) | Rome | Lazio | 00168 | Italy |
| Ospedale Pediatrico Bambino Gesù-Centro Trials ( Site 0087) | Rome | Roma | 00165 | Italy |
| Great Ormond Street Hospital ( Site 0701) | London | London, City of | WC1N 3JH | United Kingdom |
| ID | Term |
|---|---|
| D009477 | Hereditary Sensory and Autonomic Neuropathies |
| D011512 | Proteus Infections |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000608559 | Miransertib |
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