AZD2014 In NF2 Patients With Progressive or Symptomatic Meningiomas
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02831257|
Recruitment Status : Active, not recruiting
First Posted : July 13, 2016
Last Update Posted : December 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Neurofibromatosis 2 Meningioma||Drug: AZD2014||Phase 2|
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 goal of this clinical research study is to learn if the study drug AZD2014 can shrink growing or symptomatic meningiomas. 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 setting has resulted in decreased survival of tumor cells. As such, the purpose of this research is to see whether treating your meningioma with AZD2014 will result in tumor shrinkage. The safety of AZD2014 will also be studied. Your physical state, your 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 patients with your 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 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.
The FDA (the U.S. Food and Drug Administration) has not approved AZD2014 as a treatment for any disease.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm Phase 2 Study of the Dual mTORC1/mTORC2 Inhibitor AZD2014 Provided on an Intermittent Schedule for Neurofibromatosis 2 Patients With Progressive or Symptomatic Meningiomas|
|Actual Study Start Date :||August 31, 2016|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||November 2024|
18 patients will be enrolled in this study in a single stage.
- Radiographic Response Rate for target meningioma [ Time Frame: up to 24 months ]measured by volumetric MRI scans
- Median progression-free survival (PFS) [ Time Frame: From date of registration until the date of first documented progression assessed up to 24 months ]Kaplan-Meier methodology will be used to estimate progression-free survival, with the 95% confidence intervals based on Greenwood's formula.
- Progression Free Survival at 6 month [ Time Frame: 6 months of treatment ]Kaplan-Meier methodology will be used to estimate progression-free survival, with the 95% confidence intervals based on Greenwood's formula.
- Radiographic response rate for non-target meningiomas [ Time Frame: up to 24 months ]The response rate will be determined for the total volume of non-target meningiomas compared to the baseline total volume.
- Number of Participants with Adverse Events [ Time Frame: up to 24 months ]CTCAE guidelines
- Radiographic response rate of vestibular schwannomas [ Time Frame: up to 24 months ]measured by volumetric MRI
- Disease-Specific Quality of Life [ Time Frame: Baseline, 6 Months, 12 Months, 18 Months, and off study ]Disease specific quality of life will be assessed using the Neurofibromatosis 2 Impact on Quality of Life (NFTI-QOL) questionnaire.
- Vestibular Schwannoma-Specific Quality of Life [ Time Frame: Baseline, 6 Months, 12 Months, 18 Months, and off study ]Vestibular schwannoma-specific quality of life will be assessed using the Penn Acoustic Neuroma-Quality of Life (PAN-QOL) questionnaire.
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): NCT02831257
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02115|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Scott Plotkin, MD, PhD||Massachusetts General Hospital|