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mTOR Kinase Inhibitor
Vistusertib for Meningioma
Phase 2
Waitlist Available
Led By Scott R. Plotkin, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ability to swallow and retain oral medication
Participants must be willing and able to undergo regular MRI scans of the brain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is studying how well AZD2014 works in treating meningiomas that have come back.
Who is the study for?
Adults over 18 with recurrent Grade II-III meningiomas, who've had surgery and radiation, can join this trial. They should be in stable health, able to have regular MRIs, not have had more than two prior chemo treatments for their tumor, and must not be pregnant or breastfeeding. Participants need functioning major organs and a life expectancy over three months.Check my eligibility
What is being tested?
The trial is testing AZD2014 (vistusertib), a chemotherapy drug for treating recurrent meningiomas. Patients will take the drug orally to see if it helps control tumor growth after previous surgeries and therapies have failed.See study design
What are the potential side effects?
Possible side effects of AZD2014 include fatigue, digestive issues like nausea or vomiting, blood disorders that could affect cell counts and clotting times, liver function changes, potential heart rhythm problems (QTc prolongation), as well as risks of infection due to immune system suppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow and keep down pills.
Select...
I am willing and able to have regular brain MRI scans.
Select...
My meningioma is grade II-III and has worsened despite treatment.
Select...
I have a tumor that can be measured and was confirmed by an MRI within the last 30 days.
Select...
I am 18 years old or older.
Select...
I can care for myself and have not gotten worse in the past 2 weeks.
Select...
My recent blood tests show normal organ and marrow function.
Select...
I am a male willing to use contraception during and for 16 weeks after the study if my partner can bear children.
Select...
I can provide at least 20 slides or a block of my tumor for testing.
Select...
I have had fewer than three chemotherapy treatments for my meningioma.
Select...
I have had surgery and radiation for my growing meningioma.
Select...
I am not pregnant, not breastfeeding, and willing to use two effective birth control methods.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival
Secondary outcome measures
Duration of Radiographic Response
Frequency of Adverse Events
Overall Survival
+1 moreSide effects data
From 2020 Phase 2 trial • 18 Patients • NCT0283125789%
Nausea
83%
Diarrhea
72%
Hyphophosphatemia
67%
fatigue
56%
Abdominal pain
50%
Weight loss
39%
Anorexia
39%
mucositis
39%
Dry mouth
33%
Dysgeusia
33%
vomiting
28%
aspartate aminotransferase increased
22%
Constipation
17%
Hypertriglyceridemia
17%
High cholesterol
17%
infection
17%
Pruritis
17%
Rash, acneiform
11%
Headache
11%
Seizure
11%
anemia
6%
Creatine phosphokinase increased
6%
Dyspareunia
6%
Heat stroke
6%
Pneumonia
6%
Psychosis
6%
Acute kidney injury
6%
Alanine aminotransferase increased
6%
tachycardia
6%
dyspepsia
6%
Hematochezia
6%
Hyperuricemia
6%
malaise
6%
Difficulty chewing
6%
amenorrhea
6%
Urticaria
6%
vaginal pain
6%
white blood cells decreased
6%
Jaw weakness
6%
Dry skin
100%
80%
60%
40%
20%
0%
Study treatment Arm
AZD2014
Trial Design
1Treatment groups
Experimental Treatment
Group I: AZD2014Experimental Treatment1 Intervention
AZD2014 will be administered orally at a pre-determine dose
Twice daily for two consecutive days out of every seven days
Cycles will last 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vistusertib
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,327 Total Patients Enrolled
5 Trials studying Meningioma
182 Patients Enrolled for Meningioma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,125 Total Patients Enrolled
45 Trials studying Meningioma
4,209 Patients Enrolled for Meningioma
AstraZenecaIndustry Sponsor
4,257 Previous Clinical Trials
288,593,758 Total Patients Enrolled
2 Trials studying Meningioma
52 Patients Enrolled for Meningioma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken certain medications that could affect the study drug recently.I can swallow and keep down pills.I have had only a biopsy or more than 2 radiation treatments for meningioma.I haven't had cancer treatments like chemotherapy or immunotherapy in the last 14 days.I have a known kidney condition such as glomerulonephritis or Fanconi Syndrome.I have severe ongoing nausea, vomiting, or issues that affect how my stomach and intestines work.My meningioma worsened despite previous mTORC1/2 inhibitor treatments.I am HIV-positive and on combination antiretroviral therapy.I am willing and able to have regular brain MRI scans.I haven't taken any blood cell growth factors in the last 14 days.I do not have any severe ongoing illnesses that could interfere with the study.I have not had specific medical procedures or conditions in the last year.My heart's electrical activity is normal and I don't have a history of certain heart conditions.I have not received any live vaccines in the last 4 weeks.My meningioma is grade II-III and has worsened despite treatment.I can care for myself and have not gotten worse in the past 2 weeks.I am a male willing to use contraception during and for 16 weeks after the study if my partner can bear children.I have a tumor that can be measured and was confirmed by an MRI within the last 30 days.I am 18 years old or older.My recent blood tests show normal organ and marrow function.I have been diagnosed with NF2, either through clinical evaluation or genetic testing.I can provide at least 20 slides or a block of my tumor for testing.Your heart ultrasound or scan shows an abnormality before starting the study.My Type II diabetes is not under control.I have had fewer than three chemotherapy treatments for my meningioma.You have had a bad reaction to the ingredients in AZD2014 or similar medications.You are expected to live for more than three months.I may have been treated with mTOR inhibitors before.I haven't had major surgery in the last 4 weeks or minor surgery in the last 2 weeks.I have had surgery and radiation for my growing meningioma.I am not on medications that affect my heart's rhythm.I have had cancer before, but it was a specific type that is allowed.I am not pregnant, not breastfeeding, and willing to use two effective birth control methods.I have no major side effects from previous cancer treatments.I have not taken strong or moderate drugs that affect enzyme activity recently.
Research Study Groups:
This trial has the following groups:- Group 1: AZD2014
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this a pioneering clinical trial?
"Presently, AZD2014 is the subject of 9 live clinical trials in 33 cities and 10 countries. Originally initiated by AstraZeneca back in 2012 with 99 participants, Phase 1 drug approval has been achieved following 8 completed studies."
Answered by AI
What is the current enrollment of participants in this trial?
"Unfortunately, this clinical trial has ceased recruitment. It was initially posted on October 17th 2017 and its last iteration occurred a few days ago on the 15th of October 2022. If you are seeking other studies to join, there are 46 trials recruiting meningioma patients and 9 trials actively looking for participants interested in AZD2014 interventions."
Answered by AI
Are there any other experiments involving AZD2014 that have been conducted previously?
"Presently, 9 clinical trials for AZD2014 are taking place with none currently at Phase 3. 153 different locations offer the trial and Liverpool, California hosts the majority of them."
Answered by AI
Is this experiment currently accepting participants?
"This research endeavour, which was initially posted on October 17th 2017 and last amended on October 15th 2022, is not currently accepting participants. However, there are presently 55 other trials actively recruiting individuals."
Answered by AI
What types of safety protocols are in place for AZD2014?
"Our team at Power has assessed that AZD2014 is a moderately safe intervention, receiving a score of 2. This judgement takes into consideration the data from Phase 2 trials which have demonstrated some safety but no efficacy."
Answered by AI
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