Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Miransertib · 1 trial · 1 indication
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| Miransertib | DRUG | Miransertib capsules administered orally either 1 hour before or 2 hours after a meal. |
Inclusion Criteria: * Has PROS or PS and has been screened in Study MK-7075-002 (or has been approved by the Sponsor to screen for MK-7075-002) or is currently being treated with miransertib as part of Study MK-7075-002 (NCT03094832) or ArQule's CU/EAP (NCT03317366) * For males, agrees to be abstin...
Miransertib is an investigational small molecule being studied for PIK3CA-Related Overgrowth Spectrum (PROS) and Proteus Syndrome (PS), which are rare diseases. It is currently in Phase 2 clinical development and has not been approved by the FDA.
Miransertib is being developed by Merck & Company, Inc., which trades under the ticker MRK. The drug is also known as MK-7075.
Miransertib is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. There is one active Phase 2 trial, which is not yet recruiting participants.
Miransertib is being studied in a Phase 2 trial with the identifier NCT04980872. This trial is active but not recruiting and has an estimated enrollment of 60 participants with PROS or Proteus Syndrome.
Yes, Miransertib is also known as MK-7075. The clinical trial NCT04980872 refers to the drug as MK-7075, and it is being studied for the treatment of PIK3CA-Related Overgrowth Spectrum and Proteus Syndrome.