NCT03071874

Vistusertib (AZD2014) For Recurrent Grade II-III Meningiomas

A Single Arm Phase II Study Of The Dual mTORC1/mTORC2 Inhibitor Vistusertib (AZD2014) Provided On An Intermittent Schedule For Sporadic Patients With Grade II-III Meningiomas That Recur Or Progress After Surgery And Radiation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying a chemotherapy as a possible treatment for Meningiomas (recurrent). The study intervention involved in this study is: --AZD2014 (vistusertib)

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The FDA (the U.S. Food and Drug Administration) has not approved AZD2014 as a treatment for any disease. The goal of this clinical research study is to learn if the study drug AZD2014 can shrink or slow the growth of meningioma. Based on laboratory research, the cellular pathways which are blocked by AZD2014 are important for the growth and survival of meningiomas. Further, treatment of meningioma cells in the laboratory has resulted in decreased survival of tumor cells. As such, the purpose of this research is to see whether treating recurrent grade 2-3 meningioma with AZD2014 will result in tumor size stabilization or shrinkage. The safety of AZD2014 will also be studied. The physical state, the symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if AZD2014 is safe and effective in participants with this condition. AZD2014 is being studied in patients with various cancers as a single agent (a drug that is used alone to treat the cancer) or in combination with a number of well known anticancer therapies. Previous studies have also allowed investigators to determine the best dose and frequency of AZD2014 to achieve anti-tumor effects while reducing the likelihood of side effects.

Conditions

• Meningioma

Interventions

Type	Name	Description
DRUG	AZD2014	AZD2014 is a dual mTORC1/mTORC2 inhibitor

Timeline

• Start date: 2017-10-17
• Primary completion: 2022-06-30
• Completion: 2024-07-25
• First posted: 2017-03-07
• Last updated: 2022-10-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study