Alisertib in Treating Patients With Advanced or Metastatic Sarcoma

November 29, 2017 updated by: National Cancer Institute (NCI)

Phase II Study of MLN8237 in Advanced/Metastatic Sarcoma

This phase II trial studies how well alisertib works in treating patients with sarcoma that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or has spread to other places in the body (metastatic). Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the response rate (complete response [CR] + partial response [PR]) assessed for patients within each cohort: liposarcoma (cohort 1); leiomyosarcoma (non-uterine) (cohort 2); undifferentiated sarcoma (including pleomorphic undifferentiated sarcoma, formerly known as malignant fibrous histiocytoma, and myxofibrosarcoma) (cohort 3); malignant peripheral nerve sheath tumor (cohort 4); and other sarcomas (cohort 5).

SECONDARY OBJECTIVES:

I. To estimate the progression-free survival (PFS) and overall survival (OS) for patients treated with MLN8237 (alisertib) in each cohort.

II. To assess the adverse events associated with patients treated with MLN8237 in each cohort.

TERTIARY OBJECTIVES:

I. To correlate potential clinical benefit with markers of aurora kinase inhibition in pre- and post-treatment tumor biopsies.

II. To correlate clinical outcome with change in fluorine F 18 fluorothymidine (FLT)-positron emission tomography (PET) uptake at baseline versus after one week of treatment (ie, week 2 of cycle 1).

OUTLINE:

Patients receive alisertib orally (PO) twice daily (BID) on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 18 months.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona
    • Colorado
      • Aurora, Colorado, United States, 80012
        • The Medical Center of Aurora
      • Boulder, Colorado, United States, 80301
        • Boulder Community Hospital
      • Boulder, Colorado, United States, 80304
        • Rocky Mountain Cancer Centers-Boulder
      • Colorado Springs, Colorado, United States, 80907
        • Penrose-Saint Francis Healthcare
      • Colorado Springs, Colorado, United States, 80907
        • Rocky Mountain Cancer Centers-Penrose
      • Denver, Colorado, United States, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, United States, 80218
        • Presbyterian - Saint Lukes Medical Center - Health One
      • Denver, Colorado, United States, 80218
        • SCL Health Saint Joseph Hospital
      • Denver, Colorado, United States, 80220
        • Rose Medical Center
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers-Midtown
      • Denver, Colorado, United States, 80220
        • Rocky Mountain Cancer Centers-Rose
      • Denver, Colorado, United States, 80218
        • Colorado Blood Cancer Institute
      • Denver, Colorado, United States, 80222
        • Colorado Cancer Research Program NCORP
      • Durango, Colorado, United States, 81301
        • Mercy Medical Center
      • Englewood, Colorado, United States, 80113
        • Swedish Medical Center
      • Englewood, Colorado, United States, 80113
        • Comprehensive Cancer Care and Research Institute of Colorado LLC
      • Fort Collins, Colorado, United States, 80524
        • Poudre Valley Hospital
      • Golden, Colorado, United States, 80401
        • Mountain Blue Cancer Care Center
      • Greeley, Colorado, United States, 80631
        • North Colorado Medical Center
      • Greenwood Village, Colorado, United States, 80111
        • Rocky Mountain Cancer Centers-Greenwood Village
      • Lakewood, Colorado, United States, 80228
        • Saint Anthony Hospital
      • Lakewood, Colorado, United States, 80228
        • Rocky Mountain Cancer Centers-Lakewood
      • Littleton, Colorado, United States, 80122
        • Littleton Adventist Hospital
      • Lone Tree, Colorado, United States, 80124
        • Sky Ridge Medical Center
      • Lone Tree, Colorado, United States, 80124
        • Rocky Mountain Cancer Centers-Sky Ridge
      • Longmont, Colorado, United States, 80501
        • Longmont United Hospital
      • Longmont, Colorado, United States, 80501
        • Rocky Mountain Cancer Centers-Longmont
      • Loveland, Colorado, United States, 80539
        • McKee Medical Center
      • Parker, Colorado, United States, 80138
        • Parker Adventist Hospital
      • Parker, Colorado, United States, 80138
        • Rocky Mountain Cancer Centers-Parker
      • Pueblo, Colorado, United States, 81004
        • Saint Mary Corwin Medical Center
      • Pueblo, Colorado, United States, 81008
        • Rocky Mountain Cancer Centers - Pueblo
      • Wheat Ridge, Colorado, United States, 80033
        • SCL Health Lutheran Medical Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Medstar Washington Hospital Center
    • Florida
      • Hollywood, Florida, United States, 33021
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
      • Jacksonville, Florida, United States, 32224-9980
        • Mayo Clinic in Florida
    • Georgia
      • Columbus, Georgia, United States, 31904
        • John B Amos Cancer Center
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Pali Momi Medical Center
      • 'Aiea, Hawaii, United States, 96701
        • Hawaii Oncology Inc-Pali Momi
      • Honolulu, Hawaii, United States, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, United States, 96813
        • Straub Clinic and Hospital
      • Honolulu, Hawaii, United States, 96813
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, United States, 96817
        • Hawaii Cancer Care Inc-Liliha
      • Honolulu, Hawaii, United States, 96826
        • Kapiolani Medical Center for Women and Children
      • Honolulu, Hawaii, United States, 96813
        • Hawaii Cancer Care Inc-POB II
      • Honolulu, Hawaii, United States, 96817
        • Hawaii Oncology Inc-Kuakini
      • Kailua, Hawaii, United States, 96734
        • Castle Medical Center
      • Lihue, Hawaii, United States, 96766
        • Wilcox Memorial Hospital and Kauai Medical Clinic
    • Idaho
      • Post Falls, Idaho, United States, 83854
        • Kootenai Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
      • Moline, Illinois, United States, 61265
        • Garneau, Stewart C MD (UIA Investigator)
      • Moline, Illinois, United States, 61265
        • Porubcin, Michael MD (UIA Investigator)
      • Moline, Illinois, United States, 61265
        • Spector, David MD (UIA Investigator)
      • Moline, Illinois, United States, 61265
        • Trinity Medical Center
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
    • Indiana
      • Richmond, Indiana, United States, 47374
        • Reid Health
    • Iowa
      • Ames, Iowa, United States, 50010
        • Mary Greeley Medical Center
      • Ames, Iowa, United States, 50010
        • McFarland Clinic PC-William R Bliss Cancer Center
      • Bettendorf, Iowa, United States, 52722
        • Constantinou, Costas L MD (UIA Investigator)
      • Boone, Iowa, United States, 50036
        • McFarland Clinic PC-Boone
      • Clive, Iowa, United States, 50325
        • Mercy Cancer Center-West Lakes
      • Clive, Iowa, United States, 50325
        • Medical Oncology and Hematology Associates-West Des Moines
      • Des Moines, Iowa, United States, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, United States, 50309
        • Medical Oncology and Hematology Associates-Des Moines
      • Des Moines, Iowa, United States, 50316
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, United States, 50309
        • Iowa-Wide Oncology Research Coalition NCORP
      • Des Moines, Iowa, United States, 50314
        • Medical Oncology and Hematology Associates-Laurel
      • Iowa City, Iowa, United States, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
      • Jefferson, Iowa, United States, 50129
        • McFarland Clinic PC-Jefferson
      • Marshalltown, Iowa, United States, 50158
        • McFarland Clinic PC-Marshalltown
      • Sioux City, Iowa, United States, 51101
        • Siouxland Regional Cancer Center
      • Sioux City, Iowa, United States, 51104
        • Saint Luke's Regional Medical Center
      • Sioux City, Iowa, United States, 51104
        • Mercy Medical Center-Sioux City
      • West Des Moines, Iowa, United States, 50266-7700
        • Methodist West Hospital
      • West Des Moines, Iowa, United States, 50266
        • Mercy Medical Center-West Lakes
    • Kansas
      • Chanute, Kansas, United States, 66720
        • Cancer Center of Kansas - Chanute
      • Dodge City, Kansas, United States, 67801
        • Cancer Center of Kansas - Dodge City
      • El Dorado, Kansas, United States, 67042
        • Cancer Center of Kansas - El Dorado
      • Fort Scott, Kansas, United States, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, United States, 67301
        • Cancer Center of Kansas-Independence
      • Kingman, Kansas, United States, 67068
        • Cancer Center of Kansas-Kingman
      • Lawrence, Kansas, United States, 66044
        • Lawrence Memorial Hospital
      • Liberal, Kansas, United States, 67905
        • Cancer Center of Kansas-Liberal
      • Manhattan, Kansas, United States, 66502
        • Cancer Center of Kansas-Manhattan
      • McPherson, Kansas, United States, 67460
        • Cancer Center of Kansas - McPherson
      • Newton, Kansas, United States, 67114
        • Cancer Center of Kansas - Newton
      • Overland Park, Kansas, United States, 66209
        • Menorah Medical Center
      • Overland Park, Kansas, United States, 66213
        • Saint Luke's South Hospital
      • Parsons, Kansas, United States, 67357
        • Cancer Center of Kansas - Parsons
      • Prairie Village, Kansas, United States, 66208
        • Kansas City NCI Community Oncology Research Program
      • Pratt, Kansas, United States, 67124
        • Cancer Center of Kansas - Pratt
      • Salina, Kansas, United States, 67401
        • Cancer Center of Kansas - Salina
      • Wellington, Kansas, United States, 67152
        • Cancer Center of Kansas - Wellington
      • Wichita, Kansas, United States, 67208
        • Cancer Center of Kansas-Wichita Medical Arts Tower
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas - Wichita
      • Wichita, Kansas, United States, 67208
        • Associates In Womens Health
      • Wichita, Kansas, United States, 67214
        • Wichita NCI Community Oncology Research Program
      • Wichita, Kansas, United States, 67214
        • Via Christi Regional Medical Center
      • Winfield, Kansas, United States, 67156
        • Cancer Center of Kansas - Winfield
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Oncology Hematology Care Inc-Crestview
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
    • Michigan
      • Adrian, Michigan, United States, 49221
        • Bixby Medical Center
      • Adrian, Michigan, United States, 49221
        • Hickman Cancer Center
      • Escanaba, Michigan, United States, 49829
        • Green Bay Oncology - Escanaba
      • Iron Mountain, Michigan, United States, 49801
        • Green Bay Oncology - Iron Mountain
      • Monroe, Michigan, United States, 48162
        • Mercy Memorial Hospital
      • Monroe, Michigan, United States, 48162
        • Toledo Clinic Cancer Centers-Monroe
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
        • Sanford Clinic North-Bemidgi
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Edina, Minnesota, United States, 55435
        • Fairview-Southdale Hospital
      • Fridley, Minnesota, United States, 55432
        • Unity Hospital
      • Hutchinson, Minnesota, United States, 55350
        • Hutchinson Area Health Care
      • Maplewood, Minnesota, United States, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Abbott-Northwestern Hospital
      • New Ulm, Minnesota, United States, 56073
        • New Ulm Medical Center
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Medical Health Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
      • Saint Cloud, Minnesota, United States, 56303
        • Coborn Cancer Center at Saint Cloud Hospital
      • Saint Cloud, Minnesota, United States, 56303
        • Saint Cloud Hospital
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Louis Park, Minnesota, United States, 55416
        • Metro Minnesota Community Oncology Research Consortium
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Shakopee, Minnesota, United States, 55379
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, United States, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, United States, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology PA-Woodbury
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Southeast Cancer Center
      • Independence, Missouri, United States, 64057
        • Centerpoint Medical Center LLC
      • Jefferson City, Missouri, United States, 65109
        • Capital Region Medical Center-Goldschmidt Cancer Center
      • Kansas City, Missouri, United States, 64116
        • North Kansas City Hospital
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
      • Kansas City, Missouri, United States, 64118
        • Heartland Hematology and Oncology Associates Incorporated
      • Lee's Summit, Missouri, United States, 64086
        • Saint Luke's East - Lee's Summit
      • Liberty, Missouri, United States, 64068
        • Liberty Radiation Oncology Center
      • Saint Joseph, Missouri, United States, 64506
        • Heartland Regional Medical Center
      • Saint Joseph, Missouri, United States, 64507
        • Saint Joseph Oncology Inc
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63131
        • Missouri Baptist Medical Center
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic Cancer Center
      • Billings, Montana, United States, 59101
        • Saint Vincent Healthcare
      • Billings, Montana, United States, 59102
        • Montana Cancer Consortium NCORP
      • Billings, Montana, United States, 59102
        • Saint Vincent Frontier Cancer Center
      • Bozeman, Montana, United States, 59715
        • Bozeman Deaconess Hospital
      • Butte, Montana, United States, 59701
        • Saint James Community Hospital and Cancer Treatment Center
      • Great Falls, Montana, United States, 59405
        • Benefis Healthcare- Sletten Cancer Institute
      • Helena, Montana, United States, 59601
        • Saint Peter's Community Hospital
      • Kalispell, Montana, United States, 59901
        • Kalispell Regional Medical Center
      • Missoula, Montana, United States, 59802
        • Saint Patrick Hospital - Community Hospital
      • Missoula, Montana, United States, 59802
        • Montana Cancer Specialists
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • CHI Health Saint Francis
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Basking Ridge
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Commack
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
      • Rockville Centre, New York, United States, 11570
        • Memorial Sloan Kettering Rockville Centre
      • Sleepy Hollow, New York, United States, 10591
        • Memorial Sloan Kettering Sleepy Hollow
    • North Carolina
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Memorial Hospital
      • Statesville, North Carolina, United States, 28677
        • Iredell Memorial Hospital
      • Winston-Salem, North Carolina, United States, 27104
        • Southeast Clinical Oncology Research (SCOR) Consortium NCORP
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Sanford Broadway Medical Center
      • Fargo, North Dakota, United States, 58122
        • Sanford Clinic North-Fargo
      • Fargo, North Dakota, United States, 58122
        • Roger Maris Cancer Center
    • Ohio
      • Bowling Green, Ohio, United States, 43402
        • Toledo Clinic Cancer Centers-Bowling Green
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care Inc-Blue Ash
      • Cincinnati, Ohio, United States, 45202
        • Oncology Hematology Care Inc-Eden Park
      • Cincinnati, Ohio, United States, 45211
        • Oncology Hematology Care Inc-Mercy West
      • Cincinnati, Ohio, United States, 45236
        • Oncology Hematology Care Inc-Kenwood
      • Cincinnati, Ohio, United States, 45230
        • Oncology Hematology Care Inc - Anderson
      • Dayton, Ohio, United States, 45406
        • Good Samaritan Hospital - Dayton
      • Dayton, Ohio, United States, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, United States, 45415
        • Samaritan North Health Center
      • Dayton, Ohio, United States, 45420
        • Dayton NCI Community Oncology Research Program
      • Dayton, Ohio, United States, 45405
        • Grandview Hospital
      • Elyria, Ohio, United States, 44035
        • Mercy Cancer Center-Elyria
      • Elyria, Ohio, United States, 44035
        • Hematology Oncology Center Incorporated
      • Fairfield, Ohio, United States, 45014
        • Oncology Hematology Care Inc-Healthplex
      • Findlay, Ohio, United States, 45840
        • Blanchard Valley Hospital
      • Franklin, Ohio, United States, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Greenville, Ohio, United States, 45331
        • Wayne Hospital
      • Kettering, Ohio, United States, 45429
        • Kettering Medical Center
      • Lima, Ohio, United States, 45804
        • Lima Memorial Hospital
      • Maumee, Ohio, United States, 43537
        • Toledo Clinic Cancer Centers-Maumee
      • Maumee, Ohio, United States, 43537
        • Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
      • Oregon, Ohio, United States, 43616
        • Saint Charles Hospital
      • Oregon, Ohio, United States, 43616
        • Toledo Clinic Cancer Centers-Oregon
      • Sylvania, Ohio, United States, 43560
        • Flower Hospital
      • Tiffin, Ohio, United States, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, United States, 43608
        • Saint Vincent Mercy Medical Center
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic Cancer Centers-Toledo
      • Toledo, Ohio, United States, 43614
        • University of Toledo
      • Toledo, Ohio, United States, 43617
        • Toledo Community Hospital Oncology Program CCOP
      • Toledo, Ohio, United States, 43606
        • The Toledo Hospital/Toledo Children's Hospital
      • Toledo, Ohio, United States, 43623
        • Mercy Saint Anne Hospital
      • Troy, Ohio, United States, 45373
        • Upper Valley Medical Center
      • Wauseon, Ohio, United States, 43567
        • Fulton County Health Center
      • Wright-Patterson Air Force Base, Ohio, United States, 45433-5529
        • Wright-Patterson Medical Center
      • Xenia, Ohio, United States, 45385
        • Greene Memorial Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
      • Tulsa, Oklahoma, United States, 74136
        • Natalie Warren Bryant Cancer Center at Saint Francis
      • Tulsa, Oklahoma, United States, 74146
        • Warren Clinic Oncology-Tulsa
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Hazleton, Pennsylvania, United States, 18201
        • Geisinger Medical Center-Cancer Center Hazleton
      • Lewisburg, Pennsylvania, United States, 17837
        • Geisinger Medical Oncology-Lewisburg
      • Pottsville, Pennsylvania, United States, 17901
        • Geisinger Medical Oncology-Pottsville
      • State College, Pennsylvania, United States, 16801
        • Geisinger Medical Group
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Geisinger Wyoming Valley/Henry Cancer Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Florence, South Carolina, United States, 29506
        • McLeod Regional Medical Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center-Oncology Clinic
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute/University of Utah
    • Vermont
      • Berlin, Vermont, United States, 05602
        • Central Vermont Medical Center/National Life Cancer Treatment
      • Burlington, Vermont, United States, 05405
        • University of Vermont College of Medicine
    • Virginia
      • Fredericksburg, Virginia, United States, 22401
        • Fredericksburg Oncology Inc
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Green Bay, Wisconsin, United States, 54303
        • Saint Vincent Hospital Cancer Center at Saint Mary's
      • Green Bay, Wisconsin, United States, 54303
        • Green Bay Oncology Limited at Saint Mary's Hospital
      • Green Bay, Wisconsin, United States, 54301-3526
        • Green Bay Oncology at Saint Vincent Hospital
      • Manitowoc, Wisconsin, United States, 54221
        • Holy Family Memorial Hospital
      • Marinette, Wisconsin, United States, 54143
        • Bay Area Medical Center
      • New Richmond, Wisconsin, United States, 54017
        • Cancer Center of Western Wisconsin
      • Oconto Falls, Wisconsin, United States, 54154
        • Green Bay Oncology - Oconto Falls
      • Sheboygan, Wisconsin, United States, 53081
        • HSHS Saint Nicholas Hospital
      • Sturgeon Bay, Wisconsin, United States, 54235
        • Green Bay Oncology - Sturgeon Bay
    • Wyoming
      • Casper, Wyoming, United States, 82609
        • Rocky Mountain Oncology
      • Sheridan, Wyoming, United States, 82801
        • Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed sarcoma that is metastatic and/or locally advanced or locally recurrent and unresectable; confirmation of pathologic diagnosis will be performed at the registering site; patients will been rolled on one of five cohorts of the study:

    • Cohort 1: liposarcoma
    • Cohort 2: leiomyosarcoma (non-uterine)
    • Cohort 3: undifferentiated sarcoma (including malignant fibrous histiocytoma and myxofibrosarcoma)
    • Cohort 4: malignant peripheral nerve sheath tumor
    • Cohort 5: other sarcomas
  • Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST) 1.1; note: defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 2 cm with conventional techniques or as >= 1 cm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
  • Any number of prior therapies is permitted; note: the last dose of systemic therapy (including tyrosine kinase inhibitors) must have been given >= 4 weeks prior to initiation of study therapy; patients receiving BCNU or mitomycin C must have received their last dose of such therapy at least 6 weeks prior to initiation of therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 2
  • Leukocytes >= 3,000/mcL
  • Absolute neutrophil count >= 1,500/mcL
  • Platelet count >= 100,000/mcL
  • Total bilirubin =< 1.5 x institutional upper limit of normal
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (alanine aminotransferase [AST]) < 3 x institutional upper limit of normal if no liver metastases or < 5 x institutional upper limit of normal if liver metastases present
  • Creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance >= 60 mL/min/1.73m^2 for patients with creatinine levels above institutional normal
  • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of MLN8237 administration
  • Ability to understand and the willingness to sign a written informed consent document
  • According to current guidelines, patients must be able to take oral medication and to maintain a fast as required for approximately one hour before and two hours after MLN8237 administration

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients who have had radiation therapy to more than 25% of the bone marrow; whole pelvic radiation is considered to be over 25%
  • Patients who are receiving any other investigational agents
  • Patients with known brain metastases
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN8237 including, but not limited to, established allergic reaction to benzodiazepines
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, New York Heart Association (NYHA) class II-IV heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women; note: women of child-bearing potential must have a negative serum or urine pregnancy test within 7 days prior to registration; breastfeeding should be discontinued if the mother is treated with MLN8237
  • Leiomyosarcoma of the uterus
  • Patients known to be human immunodeficiency virus (HIV)-positive on antiretroviral therapy
  • Prior allogeneic bone marrow or organ transplantation
  • Known history of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness such as severe chronic obstructive pulmonary disease, requirement for supplemental oxygen, or any conditions that could result in excessive toxicity associated with the benzodiazepine-like effects of MLN8237
  • Requirement for constant administration of proton pump inhibitor, histamine-2 (H2) antagonist, or pancreatic enzymes; note: intermittent uses of antacids or H2 antagonists are allowed
  • Inability to swallow oral medication or to maintain a required fast for approximately one hour before and two hours after MLN8237 administration or any condition that would modify small bowel absorption of oral medications, including malabsorption or resection of pancreas or upper bowel
  • Treatment with clinically significant enzyme inducers, such as the enzyme-inducing antiepileptic drugs phenytoin, carbamazepine, oxcarbazepine, primidone or phenobarbital, or rifampin, rifabutin, rifapentine, or St. John's wort within 14 days prior to the first dose of MLN8237 and during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (alisertib)
Patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Alisertib
Given PO
Other Names:
  • MLN8237
  • Aurora A Kinase Inhibitor MLN8237
  • MLN-8237

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Primary Endpoint for This Trial Was the Percent of Confirmed Tumor Responses. Confirmed Tumor Response to Treatment Was Defined as a Complete or Partial Response(Per RECIST 1.1) on Two Consecutive Evaluations at Least 6 Weeks Apart.
Time Frame: Up to 18 months
The primary endpoint was estimated by the number of confirmed responses divided by the total number of evaluable patients per cohort. The study used a two stage Simon design to assess the primary endpoint. A confirmed tumor response rate of 5% was considered not promising; an observed confirmed response rate of 25% was considered promising. One confirmed response within the initial 9 patients enrolled within each cohort, expanded enrollment to 24 patients in that cohort. 3 out of 24 patients with confirmed tumor responses was considered evidence that this treatment could be recommended for further testing. This study design yielded 90% power to detect a true confirmed response rate of at least 25% at .10 level of significance if the true rate is at most 5%. There was a 63% chance of stopping early if the true confirmed response rate was 5%.
Up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: The time between registration and death, assessed up to 18 months
The distribution will be estimated by the methods of Kaplan and Meier. The estimates of survival at specific time points will be calculated (eg, median, 6 month survival).
The time between registration and death, assessed up to 18 months
Progression Free Survival (PFS)
Time Frame: The time between registration to disease progression or death, assessed up to 18 months
The distribution will be estimated by the methods of Kaplan and Meier. The estimates of PFS at specific time points will be calculated (eg, median, 1 year PFS).
The time between registration to disease progression or death, assessed up to 18 months
Adverse Events
Time Frame: During treatment and up to 5 years
Adverse Events: Incidence of adverse events, assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Adverse events were collected every cycle during treatment and up to one month after treatment. Adverse events were summarized using summary statistics and frequency tables for each separate cohort. Per protocol, analysis was descriptive in nature. In this section, the number of patients that reported a grade 4 or higher event are summarized. A complete listing of Adverse Events is provided in the Adverse Events section below.
During treatment and up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Mark Dickson, Alliance for Clinical Trials in Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2012

Primary Completion (Actual)

August 2, 2015

Study Registration Dates

First Submitted

July 26, 2012

First Submitted That Met QC Criteria

July 26, 2012

First Posted (Estimate)

July 30, 2012

Study Record Updates

Last Update Posted (Actual)

November 30, 2017

Last Update Submitted That Met QC Criteria

November 29, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-01991 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA180821 (U.S. NIH Grant/Contract)
  • U10CA031946 (U.S. NIH Grant/Contract)
  • CDR0000737403
  • A091102 (Other Identifier: CTEP)
  • CALGB-A091102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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