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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

Must not have

Exposure to specific substrates of the drug transporters OATP1B1, OATP1B3, MATE1 and MATE2K within the appropriate wash-out period before the first dose of study treatment

Participants who received biopsy only or have received more than 2 prior courses of radiation for meningioma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

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.

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.

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 below

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I can swallow and keep down pills.

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I am willing and able to have regular brain MRI scans.

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My meningioma is grade II-III and has worsened despite treatment.

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I am 18 years old or older.

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My recent blood tests show normal organ and marrow function.

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I am a male willing to use contraception during and for 16 weeks after the study if my partner can bear children.

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I can provide at least 20 slides or a block of my tumor for testing.

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I have had fewer than three chemotherapy treatments for my meningioma.

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I have had surgery and radiation for my growing meningioma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken certain medications that could affect the study drug recently.

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I have had only a biopsy or more than 2 radiation treatments for meningioma.

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I have a known kidney condition such as glomerulonephritis or Fanconi Syndrome.

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I have severe ongoing nausea, vomiting, or issues that affect how my stomach and intestines work.

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My meningioma worsened despite previous mTORC1/2 inhibitor treatments.

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I am HIV-positive and on combination antiretroviral therapy.

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I haven't taken any blood cell growth factors in the last 14 days.

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I do not have any severe ongoing illnesses that could interfere with the study.

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I have been diagnosed with NF2, either through clinical evaluation or genetic testing.

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My Type II diabetes is not under control.

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I am not on medications that affect my heart's rhythm.

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I have no major side effects from previous cancer treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival

Secondary study objectives

Duration of Radiographic Response

Frequency of Adverse Events

Overall Survival

+1 more

Side effects data

From 2020 Phase 2 trial • 18 Patients • NCT02831257

89%

Nausea

83%

Diarrhea

72%

Hyphophosphatemia

67%

fatigue

56%

Abdominal pain

50%

Weight loss

39%

mucositis

39%

Anorexia

39%

Dry mouth

33%

Dysgeusia

33%

vomiting

28%

aspartate aminotransferase increased

22%

Constipation

17%

infection

17%

Rash, acneiform

17%

Pruritis

17%

High cholesterol

17%

Hypertriglyceridemia

11%

Seizure

11%

Headache

11%

anemia

vaginal pain

Hyperuricemia

Difficulty chewing

Dry skin

Heat stroke

white blood cells decreased

amenorrhea

Urticaria

tachycardia

malaise

Pneumonia

Creatine phosphokinase increased

Hematochezia

Jaw weakness

Dyspareunia

Psychosis

dyspepsia

Acute kidney injury

Alanine aminotransferase increased

100%

80%

60%

40%

20%

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

0 / 21Eligibility criteria met