Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas
Launched by ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY · Aug 12, 2015
Trial Information
Current as of May 03, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating the effectiveness of four different medications—vismodegib, GSK2256098 (a FAK inhibitor), capivasertib, and abemaciclib—in treating patients with progressive meningiomas, which are tumors located in the brain or spinal cord. The aim is to see if these drugs can help stop or slow the growth of these tumors in patients whose condition is worsening. The trial is currently recruiting participants aged 18 and older, particularly those with specific genetic mutations related to their meningiomas, including variants in the NF2 gene.
To be eligible for the trial, patients must have a confirmed diagnosis of meningioma and show signs of either progressive disease or measurable residual disease following surgery. Participants can expect to receive one or more of the study drugs, and they will be monitored closely throughout the trial for any side effects and to assess how well the treatment is working. It's important to note that participants should not be pregnant or nursing, and they must meet certain health criteria, such as stable blood pressure and blood counts. This study aims to provide new insights into potential treatments for this challenging condition.
Gender
ALL
Eligibility criteria
- * Documentation of disease:
- • Histologic documentation: histologically proven intracranial meningioma as documented by central pathology review
- • Molecular documentation: Presence of SMO, PTCH1, NF2, CDKN2A, AKT1, PIK3CA, PTEN mutations, CDKN2A copy number loss, CDK4, CDK6, CCND1, CCND2, CCND3, or CCNE1 copy number gain in tumor sample as documented specifically by the central laboratory, regardless of whether prior genotype testing outside of the central laboratory was performed
- * Progressive OR residual disease, as defined by the following:
- • Residual measurable disease: residual measurable disease immediately after surgery without requirement for progression; for grade I disease, progression pre-operatively needs to be documented, with an increase in size of the measurable primary lesion on imaging by 25% or more (bidirectional area); the change must occur between scans separated by no more than 25 months; for patients with SMO/PTCH1 mutations enrolling to receive vismodegib, the change can occur between scans separated by up to 25 months; residual measurable disease will be defined by bidimensionally measurable lesions with clearly defined margins by MRI scans, with a minimum diameter of 10 mm in both dimensions
- • Progressive measurable disease: progression defined as an increase in size of the measurable primary lesion on imaging by 25% or more (bidirectional area); the change must occur between scans separated by no more than 25 months
- • Post radiation patients: patients with measurable and progressive meningioma who have received radiation are potentially eligible, but need to show evidence of progressive disease after completion of radiation; if the progressive meningioma lesion has been radiated, at least 24 weeks must have elapsed from completion of radiation to registration; if the progressive lesion is outside of the radiation field, then an interval of at least 2 weeks must have elapsed from completion of radiation to registration
- • Measurable disease: measurable disease is defined by a bidimensionally measurable main lesion on MRI or computed tomography (CT) images (MRI preferred) with clearly defined margins and a minimum diameter of 10 mm in both dimensions; multifocal disease is allowed
- • Prior treatment
- • Prior medical therapy is allowed but not required
- • No limit on number of prior therapies
- • No chemotherapy, or other investigational agents within 28 days prior to registration
- • No other concurrent investigational agents or other meningioma-directed therapy (chemotherapy, radiation) while on study; additionally, no cases of nitrosourea or mitomycin C within 6 weeks prior to registration
- • For patients treated with external beam radiation, interstitial brachytherapy or radiosurgery, an interval \> 4 weeks must have elapsed from completion of radiation therapy to registration; if the progressive lesion is outside of the radiation field, then an interval of at least 2 weeks must have elapsed from completion of radiation to registration
- • Steroid dosing stable for at least 4 days
- • Recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or less toxicity from other agents with exception of alopecia and fatigue
- • No craniotomy 28 days prior to and after registration
- * Not pregnant and not nursing:
- • \* A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
- • For patients with NF2/CDKN2A/AKT1/PIK3CA/PTEN mutation, CKDN2A copy number loss, or CDK4/CDK6/CCND1/CCND2/CCND3/CCNE1 copy number gain: Age \>= 18 years
- • For patients with SMO/PTCH1 mutation: Age \>= 30 years
- • Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
- * Patient history:
- • Patients with history of neurofibromatosis (NF) may have other stable central nervous system (CNS) tumors (schwannoma, acoustic neuroma or ependymoma) if lesions have been stable for 6 months
- • No metastatic meningiomas (as defined by extracranial meningiomas outside of CNS) allowed; spinal meningiomas are allowed
- • No history of allergic reactions attributed to compounds of similar or biologic composition to assigned study drug
- • No known active hepatitis B or C
- • No current Child Pugh class B or C liver disease
- • No uncontrolled gastric ulcer disease (grade 3 gastric ulcer disease within 28 days of registration)
- • No uncontrolled hypertension defined as blood pressure (BP) \> 140/90
- • No abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 28 days prior to registration
- • No major surgery within 28 days prior to registration for any patients with AKT1/PIK3CA/PTEN mutations receiving capivasertib
- • For patients going on to receive capivasertib (i.e. enrolled after Update #08)
- * Patients should not have any of the following cardiac criteria:
- • Any clinically important abnormalities in rhythm, conduction, or morphology of resting electrocardiogram (EKG) (e.g., complete left bundle branch block, third degree heart block)
- • Any factors that increase the risk of corrected QT (QTc) prolongation or risk of arrhythmic events such as heart failure, hypokalemia, potential for Torsade de Pointes, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval
- • Experience any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association (NYHA) class \>= II
- • Uncontrolled hypertension (systolic blood pressure \[SBP\] \< 90 mmHg and/or diastolic blood pressure \[DBP\] \< 50 mmHg)
- • Cardiac ejection fraction outside institutional range of normal or \< 50% (whichever is higher) as measured by echocardiogram (or multigated acquisition \[MUGA\] scan if an echocardiogram can't be performed or is inconclusive); left ventricular ejection fraction (LVEF) below lower limit of normal for site
- * Patients should not have any of the following criteria:
- • With the exception of alopecia, any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of registration
- • Hemoglobin \< 9 g/dL (\< 5.59 mmol/L); note: any blood transfusion must be \>= 14 days prior to the determination of a hemoglobin \>= 9 g/dL (\>= 5.59 mmol/L)
- • Proteinuria 3+ on dipstick analysis or \> 500 mg/24 hours
- • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of capivasertib
- • History of hypersensitivity to active or inactive excipients of capivasertib or drugs with a similar chemical structure or class to capivasertib
- • Current disease or condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
- • Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
- • Previous allogeneic bone marrow transplant
- • Known immunodeficiency syndrome
- * Concomitant medications (only regarding NF2/CDKN2A/CDK4/CDK6/CCND1/CCND2/CCND3/CCNE1/AKT1/PIK3CA/PTEN genetic alterations):
- • Chronic concomitant treatment with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors must discontinue the drug for 14 days prior to registration on the study for patients with NF2 mutation enrolled to GSK2256098, as well as for patients with AKT1/PIK3CA/PTEN mutations enrolled to capivasertib
- • For NF2 patients going on to receive GSK2256098 and for patients with AKT1/PIK3CA/PTEN mutations enrolled to capivasertib: concomitant treatment with strong CYP3A4 inducers or CYP2D6 substrates is not allowed; patients must discontinue the drug 14 days prior to registration
- • For NF2 patients going on to receive abemaciclib: avoid concomitant use of CYP3A inducers and strong CYP3A inhibitors; use caution with coadministered moderate or weak CYP3A inhibitors
- * Diabetic status:
- • For patients with NF2 or SMO/PTCH1 mutations: No uncontrolled diabetes defined as a known diabetic with HBA1C \> 7.5 OR fasting glucose \> 140 mg/dL.
- * For patients with AKT1/PIK3CA/PTEN mutations:
- • Glycosylated hemoglobin (HbA1C) \< 8.0% (63.9 mmol/mol)
- • No type 1 diabetes mellitus
- • No requirement for insulin for routine diabetic management and control
- • No requirement for more than two oral hypoglycemic medications for routine diabetic management and control
- • Patients with a pre-existing diagnosis of type 2 diabetes mellitus must have fasting glucose \< 9.3 mmol/L (167mg/dL); fasting is defined as no caloric intake for at least 8 hours
- • Patients without a pre-existing diagnosis of type 2 diabetes mellitus must have fasting glucose =\< 7.0 mmol/L (126 mg/dL); fasting is defined as no caloric intake for at least 8 hours
- • Absolute neutrophil count (ANC) \>= 1,500/mm\^3
- • Platelet count \>= 100,000/mm\^3
- • Creatinine OR =\< 1.5 mg/dl x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance \> 50 mL/min
- • Urine protein:creatinine ratio (UPC) =\< 45 mg/mmol
- • Total bilirubin =\< 1.5 x upper limit of normal (ULN); except in case of Gilbert's disease
- • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x ULN
- • Sodium, potassium, total calcium (corrected for serum albumin) \& phosphorus within normal limits per institutional guidelines
- • QTcF \< 450 msec (QT calculated using Fridericia formula)
- • Mean resting heart rate (determined from EKG) 50-100 beats per minute (BMP) (must be obtained from 12-lead EKG defined by a triplicate EKG for patients assigned to the capivasertib arm; patients assigned to all other arms will require a single EKG
- • No uncontrolled medical comorbidities per investigator discretion (e.g. interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or pre-existing Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea)
- • ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM: Hemoglobin \>= 8 g/dL
- • \* Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator; initial treatment must not begin earlier than the day after the erythrocyte transfusion
- • ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM: Prior Treatment
- • Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \[CTCAE\] grade =\< 1) from the acute effects of chemotherapy except for residual alopecia or grade 2 peripheral neuropathy prior to registration; a washout period of at least 28 days is required between last chemotherapy dose and registration (provided the patient did not receive radiotherapy)
- • Patients who received adjuvant radiotherapy must have completed and fully recovered from the acute effects of radiotherapy; a washout period of at least 28 days is required between end of radiotherapy and registration
- • ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM: No active bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]); screening is not required for enrollment in the absence of symptoms
- • ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM: No personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest
About Alliance For Clinical Trials In Oncology
The Alliance for Clinical Trials in Oncology is a prominent cooperative group dedicated to conducting high-quality, innovative clinical research aimed at improving cancer treatment and patient outcomes. Comprising a diverse network of institutions and investigators, the Alliance focuses on developing and implementing clinical trials that evaluate new therapies, treatment combinations, and prevention strategies across various cancer types. By fostering collaboration among oncologists, researchers, and healthcare professionals, the Alliance aims to accelerate the translation of scientific discoveries into effective clinical practices, ultimately enhancing the standard of care for cancer patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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East China Township, Michigan, United States
Flint, Michigan, United States
Flint, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Livonia, Michigan, United States
Macomb, Michigan, United States
Macomb, Michigan, United States
Marlette, Michigan, United States
Pontiac, Michigan, United States
Pontiac, Michigan, United States
Pontiac, Michigan, United States
Rochester Hills, Michigan, United States
Saginaw, Michigan, United States
Sterling Heights, Michigan, United States
Warren, Michigan, United States
Warren, Michigan, United States
Warren, Michigan, United States
Warren, Michigan, United States
West Branch, Michigan, United States
Ypsilanti, Michigan, United States
Minneapolis, Minnesota, United States
Henderson, Nevada, United States
Henderson, Nevada, United States
Henderson, Nevada, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Centerville, Ohio, United States
Delaware, Ohio, United States
Grove City, Ohio, United States
Marion, Ohio, United States
West Chester, Ohio, United States
Baker City, Oregon, United States
Ontario, Oregon, United States
Lewisburg, Pennsylvania, United States
South Jordan, Utah, United States
Cody, Wyoming, United States
Cody, Wyoming, United States
Anchorage, Alaska, United States
Anchorage, Alaska, United States
Anchorage, Alaska, United States
Anchorage, Alaska, United States
Anchorage, Alaska, United States
Colorado Springs, Colorado, United States
Durango, Colorado, United States
Durango, Colorado, United States
Golden, Colorado, United States
Lakewood, Colorado, United States
Parker, Colorado, United States
Pueblo, Colorado, United States
Thornton, Colorado, United States
Creston, Iowa, United States
Bardstown, Kentucky, United States
Corbin, Kentucky, United States
Lexington, Kentucky, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Shepherdsville, Kentucky, United States
Kearney, Nebraska, United States
Commack, New York, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Hixson, Tennessee, United States
Ooltewah, Tennessee, United States
Aberdeen, Washington, United States
Enumclaw, Washington, United States
Seattle, Washington, United States
Shelton, Washington, United States
Tacoma, Washington, United States
Yelm, Washington, United States
Carbondale, Illinois, United States
Carterville, Illinois, United States
Centralia, Illinois, United States
Danville, Illinois, United States
Decatur, Illinois, United States
Effingham, Illinois, United States
Mattoon, Illinois, United States
O'fallon, Illinois, United States
Ottawa, Illinois, United States
Swansea, Illinois, United States
Yorkville, Illinois, United States
Crestview Hills, Kentucky, United States
Louisville, Kentucky, United States
Marrero, Louisiana, United States
Brighton, Michigan, United States
Brownstown, Michigan, United States
Canton, Michigan, United States
Chelsea, Michigan, United States
Clinton Township, Michigan, United States
Novi, Michigan, United States
West Bloomfield, Michigan, United States
Ypsilanti, Michigan, United States
Maple Grove, Minnesota, United States
Wyoming, Minnesota, United States
Bonne Terre, Missouri, United States
Sainte Genevieve, Missouri, United States
Sullivan, Missouri, United States
Sunset Hills, Missouri, United States
Omaha, Nebraska, United States
Asheville, North Carolina, United States
Centerville, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Fairfield, Ohio, United States
Findlay, Ohio, United States
Findlay, Ohio, United States
Franklin, Ohio, United States
Greenville, Ohio, United States
Kettering, Ohio, United States
Middletown, Ohio, United States
Sidney, Ohio, United States
Troy, Ohio, United States
Clackamas, Oregon, United States
Mount Vernon, Washington, United States
Seattle, Washington, United States
Sequim, Washington, United States
Spokane Valley, Washington, United States
Spokane, Washington, United States
Spokane, Washington, United States
Fond Du Lac, Wisconsin, United States
Harrison, New York, United States
Ames, Iowa, United States
Boone, Iowa, United States
Fort Dodge, Iowa, United States
Jefferson, Iowa, United States
Marshalltown, Iowa, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Pottsville, Pennsylvania, United States
Basking Ridge, New Jersey, United States
San Rafael, California, United States
Norton Shores, Michigan, United States
Monticello, Minnesota, United States
Carson City, Nevada, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Reno, Nevada, United States
Gaffney, South Carolina, United States
Greer, South Carolina, United States
Union, South Carolina, United States
Eau Claire, Wisconsin, United States
Portland, Oregon, United States
Fremont, California, United States
London, Kentucky, United States
Farmington, Utah, United States
Poulsbo, Washington, United States
Milwaukee, Wisconsin, United States
Mukwonago, Wisconsin, United States
Waukesha, Wisconsin, United States
Trumbull, Connecticut, United States
Louisville, Kentucky, United States
Ashland, Wisconsin, United States
Selinsgrove, Pennsylvania, United States
Pasadena, California, United States
Deerfield Beach, Florida, United States
Phoenix, Arizona, United States
Elk Grove, California, United States
Rocklin, California, United States
Sacramento, California, United States
San Luis Obispo, California, United States
Santa Maria, California, United States
Woodland, California, United States
Tawas City, Michigan, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Perrysburg, Ohio, United States
Seattle, Washington, United States
Sacramento, California, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Pahrump, Nevada, United States
Beavercreek, Ohio, United States
Martinsburg, West Virginia, United States
Stevens Point, Wisconsin, United States
The Woodlands, Texas, United States
Arroyo Grande, California, United States
Aitkin, Minnesota, United States
Deer River, Minnesota, United States
Hibbing, Minnesota, United States
Sandstone, Minnesota, United States
Virginia, Minnesota, United States
Hazleton, Pennsylvania, United States
Ashland, Wisconsin, United States
Ballwin, Missouri, United States
Washington, Missouri, United States
Newport Beach, California, United States
Plantation, Florida, United States
Bellevue, Nebraska, United States
Omaha, Nebraska, United States
Redmond, Oregon, United States
Grand Junction, Colorado, United States
Detroit Lakes, Minnesota, United States
Fosston, Minnesota, United States
Park Rapids, Minnesota, United States
Jamestown, North Dakota, United States
Springfield, Ohio, United States
Libertyville, Illinois, United States
Kingman, Arizona, United States
Dixon, Illinois, United States
Washington, Illinois, United States
Farmington, Missouri, United States
Henderson, Nevada, United States
Henderson, Nevada, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
San Mateo, California, United States
Colorado Springs, Colorado, United States
Burnsville, Minnesota, United States
Bozeman, Montana, United States
Shelby, Michigan, United States
Cambridge, Minnesota, United States
Princeton, Minnesota, United States
Carmichael, California, United States
Barrington, Illinois, United States
Crystal Lake, Illinois, United States
Kalamazoo, Michigan, United States
Baxter, Minnesota, United States
Ely, Minnesota, United States
International Falls, Minnesota, United States
Moose Lake, Minnesota, United States
Dublin, Ohio, United States
Cudahy, Wisconsin, United States
Humble, Texas, United States
Missoula, Montana, United States
Torrance, California, United States
Little Rock, Arkansas, United States
Nampa, Idaho, United States
Alton, Illinois, United States
Springfield, Illinois, United States
Grand Island, Nebraska, United States
Perrysburg, Ohio, United States
Toledo, Ohio, United States
Toledo, Ohio, United States
Lexington, Kentucky, United States
Aurora, Colorado, United States
Pekin, Illinois, United States
Des Moines, Iowa, United States
Kalispell, Montana, United States
Mount Sterling, Kentucky, United States
Lebanon, New Hampshire, United States
Moon, Pennsylvania, United States
Wyoming, Michigan, United States
Grand Rapids, Michigan, United States
Muskegon, Michigan, United States
Troy, Ohio, United States
Nampa, Idaho, United States
Grove City, Ohio, United States
Pontiac, Michigan, United States
Ann Arbor, Michigan, United States
Brighton, Michigan, United States
Chelsea, Michigan, United States
Centralia, Illinois, United States
Danville, Illinois, United States
New Albany, Ohio, United States
Boone, Iowa, United States
Fort Dodge, Iowa, United States
Jefferson, Iowa, United States
Marshalltown, Iowa, United States
Los Angeles, California, United States
Ames, Iowa, United States
Merced, California, United States
Canton, Michigan, United States
Stevens Point, Wisconsin, United States
Minocqua, Wisconsin, United States
Osage Beach, Missouri, United States
Oak Lawn, Illinois, United States
Palos Heights, Illinois, United States
Ankeny, Iowa, United States
Sunset Hills, Missouri, United States
Marysville, Ohio, United States
Niles, Michigan, United States
Reed City, Michigan, United States
Saint Joseph, Michigan, United States
O'fallon, Illinois, United States
Clive, Iowa, United States
Lansing, Michigan, United States
Carmichael, California, United States
Grand Rapids, Michigan, United States
Saint Joseph, Michigan, United States
Jefferson City, Missouri, United States
Pontiac, Michigan, United States
Madison, Wisconsin, United States
Wilmington, Ohio, United States
Silverdale, Washington, United States
Saint Johnsbury, Vermont, United States
Dayton, Ohio, United States
Grand Rapids, Michigan, United States
Sandpoint, Idaho, United States
Baker City, Oregon, United States
Ontario, Oregon, United States
Dearborn, Michigan, United States
Saginaw, Michigan, United States
Tawas City, Michigan, United States
West Harrison, New York, United States
East China, Michigan, United States
Macomb Township, Michigan, United States
Macomb Township, Michigan, United States
Shelby Township, Michigan, United States
Moon Township, Pennsylvania, United States
Detroit, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Macomb, Michigan, United States
Warren, Michigan, United States
Flint, Michigan, United States
Kalamazoo, Michigan, United States
Warren, Michigan, United States
Kearney, Nebraska, United States
East China Township, Michigan, United States
Macomb, Michigan, United States
Warren, Michigan, United States
Havre, Montana, United States
Grosse Pointe Woods, Michigan, United States
Rochester Hills, Michigan, United States
Westminster, Colorado, United States
Mount Vernon, Illinois, United States
Ankeny, Iowa, United States
Clive, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
East China, Michigan, United States
Macomb Township, Michigan, United States
Macomb Township, Michigan, United States
Denver, Colorado, United States
Waukee, Iowa, United States
Rolla, Missouri, United States
Littleton, Colorado, United States
Parker, Colorado, United States
Cape Girardeau, Missouri, United States
Union, South Carolina, United States
Oak Park, Illinois, United States
Patients applied
Trial Officials
Priscilla Brastianos, MD
Study Chair
Massachusetts General Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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