Phase II Study Of Vistusertib (AZD2014) For Recurrent Grade II-III Meningiomas
This research study is studying a chemotherapy as a possible treatment for Meningiomas (recurrent).
The study intervention involved in this study is:
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
- Progression Free Survival [ Time Frame: 6 months ]proportion of patients alive and without progression
- Overall Survival [ Time Frame: 2 years ]time from registration to death due to any cause, or censored at date last known alive
- Radiographic Response Rate [ Time Frame: 2 years ]proportion of patients with complete or partial radiographic response
- Duration of Radiographic Response [ Time Frame: 2 years ]The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, or death due to any cause. Participants without events reported are censored at the last disease evaluation).
- Frequency of Adverse Events [ Time Frame: 2 years ]frequency of subjects experiencing a specific adverse event will be tabulated grade, and relationship to study drug
|Anticipated Study Start Date:||April 15, 2017|
|Estimated Study Completion Date:||July 25, 2024|
|Estimated Primary Completion Date:||July 25, 2020 (Final data collection date for primary outcome measure)|
AZD2014 is a dual mTORC1/mTORC2 inhibitor
Other Name: vistusertib
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03071874
|Contact: Scott R. Plotkin, MD, PhDfirstname.lastname@example.org|
|United States, Illinois|
|Northwestern University||Not yet recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Priya Kumthekar, MD 312-695-7950 Priya.Kumthekar@nm.org|
|United States, Massachusetts|
|Massachusetts general Hospital||Not yet recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Scott R. Plotkin, MD, PhD 617-726-3650 email@example.com|
|Principal Investigator: Scott R. Plotkin, MD, PhD|
|Dana Farber Cancer Institute||Not yet recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Patrick Wen, MD 617-632-2166 firstname.lastname@example.org|
|Principal Investigator: Patrick Wen, MD|
|Principal Investigator:||Scott R. Plotkin, MD, PhD||Massachusetts General Hospital|