A Study of the Safety and Tolerability in Participants With PIK3CA-related Overgrowth Spectrum or Proteus Syndrome Who Are Being Treated With Miransertib (MK-7075) in Other Studies (MK-7075-006)
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|ClinicalTrials.gov Identifier: NCT04980872|
Recruitment Status : Recruiting
First Posted : July 28, 2021
Last Update Posted : September 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome (PS)||Drug: Miransertib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Multicenter|
|Masking:||None (Open Label)|
|Masking Description:||None (Open-label)|
|Official Title:||A Multicenter, Open-label, Phase 2, Extension Trial to Study the Long-term Safety in Participants With PROS or Proteus Syndrome Who Are Currently Being Treated With Miransertib in Other Studies|
|Estimated Study Start Date :||October 12, 2021|
|Estimated Primary Completion Date :||August 30, 2025|
|Estimated Study Completion Date :||August 30, 2025|
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 48 cycles. A cycle is 28 days long.
Miransertib capsules administered orally either 1 hour before or 2 hours after a meal.
- Number of participants experiencing a Serious Adverse Event (SAE) [ Time Frame: Up to approximately 4 years ]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.
- Number of participants discontinuing study treatment due to an Adverse Event (AE) [ Time Frame: Up to approximately 4 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04980872
|Contact: Toll Free Number||1-888-577-8839||Trialsites@merck.com|
|Bundaberg Base Hospital ( Site 0202)||Recruiting|
|Bundaberg, Queensland, Australia, 4670|
|Contact: Study Coordinator +61741502222|
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|