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Also known as MK-7075, ARQ 092
Miransertib · 2 trials · 4 indications
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. |
| ARQ 092 | DRUG | Subjects in this study will receive ARQ 092 orally at dose levels specified for their respective dose cohorts. Dosing will begin at 10 mg every other day (QOD) and will escalate until the MTD or RP2D is determined. Cycles will be repeated in four-week (28 day) intervals until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment will be permitted. |
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 regulatory authorities.
Miransertib is an inhibitor of AKT1, AKT2, and AKT3. It is being studied in patients with PIK3CA-Related Overgrowth Spectrum (PROS) and Proteus Syndrome (PS), conditions associated with overactivation of the PI3K/AKT signaling pathway.
Miransertib is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and tolerability in patients with PIK3CA-Related Overgrowth Spectrum (PROS) and Proteus Syndrome (PS).
Miransertib is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The ongoing Phase 2 trial is active but not recruiting participants.
Miransertib is being evaluated in a Phase 2 clinical trial with the identifier NCT04980872. This study is assessing the safety and tolerability of Miransertib (MK-7075) in approximately 60 participants with PIK3CA-Related Overgrowth Spectrum (PROS) or Proteus Syndrome (PS) across the United States, Australia, Brazil, Italy, and the United Kingdom.
Yes, Miransertib is also known as MK-7075. In clinical trial NCT04980872, the drug is referred to as Miransertib (MK-7075), confirming that these names refer to the same investigational compound being developed by Merck & Company, Inc.