Alisertib in Treating Patients With Advanced or Metastatic Sarcoma
Phase II Study of MLN8237 in Advanced/Metastatic Sarcoma
6 other identifiers
interventional
72
1 country
235
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
235 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2012
CompletedFirst Posted
Study publicly available on registry
July 30, 2012
CompletedStudy Start
First participant enrolled
August 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2015
CompletedResults Posted
Study results publicly available
December 28, 2016
CompletedNovember 30, 2017
November 1, 2017
2.9 years
July 26, 2012
August 22, 2016
November 29, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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 Outcomes (3)
Overall Survival (OS)
The time between registration and death, assessed up to 18 months
Progression Free Survival (PFS)
The time between registration to disease progression or death, assessed up to 18 months
Adverse Events
During treatment and up to 5 years
Study Arms (1)
Treatment (alisertib)
EXPERIMENTALPatients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions
Given PO
Eligibility Criteria
You may qualify if:
- 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
- +3 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (235)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
Boulder Community Hospital
Boulder, Colorado, 80301, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218, United States
SCL Health Saint Joseph Hospital
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220, United States
Rose Medical Center
Denver, Colorado, 80220, United States
Colorado Cancer Research Program NCORP
Denver, Colorado, 80222, United States
Mercy Medical Center
Durango, Colorado, 81301, United States
Comprehensive Cancer Care and Research Institute of Colorado LLC
Englewood, Colorado, 80113, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Mountain Blue Cancer Care Center
Golden, Colorado, 80401, United States
North Colorado Medical Center
Greeley, Colorado, 80631, United States
Rocky Mountain Cancer Centers-Greenwood Village
Greenwood Village, Colorado, 80111, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, 80228, United States
Saint Anthony Hospital
Lakewood, Colorado, 80228, United States
Littleton Adventist Hospital
Littleton, Colorado, 80122, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, 80124, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Longmont United Hospital
Longmont, Colorado, 80501, United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, 80501, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
Parker Adventist Hospital
Parker, Colorado, 80138, United States
Rocky Mountain Cancer Centers-Parker
Parker, Colorado, 80138, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004, United States
Rocky Mountain Cancer Centers - Pueblo
Pueblo, Colorado, 81008, United States
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, 80033, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
John B Amos Cancer Center
Columbus, Georgia, 31904, United States
Hawaii Cancer Care Inc-POB II
Honolulu, Hawaii, 96813, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Straub Clinic and Hospital
Honolulu, Hawaii, 96813, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii, 96817, United States
Hawaii Oncology Inc-Kuakini
Honolulu, Hawaii, 96817, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Castle Medical Center
Kailua, Hawaii, 96734, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, 96766, United States
Hawaii Oncology Inc-Pali Momi
‘Aiea, Hawaii, 96701, United States
Pali Momi Medical Center
‘Aiea, Hawaii, 96701, United States
Kootenai Cancer Center
Post Falls, Idaho, 83854, United States
Northwestern University
Chicago, Illinois, 60611, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Garneau, Stewart C MD (UIA Investigator)
Moline, Illinois, 61265, United States
Porubcin, Michael MD (UIA Investigator)
Moline, Illinois, 61265, United States
Spector, David MD (UIA Investigator)
Moline, Illinois, 61265, United States
Trinity Medical Center
Moline, Illinois, 61265, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Reid Health
Richmond, Indiana, 47374, United States
Mary Greeley Medical Center
Ames, Iowa, 50010, United States
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, 50010, United States
Constantinou, Costas L MD (UIA Investigator)
Bettendorf, Iowa, 52722, United States
McFarland Clinic PC-Boone
Boone, Iowa, 50036, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, 50325, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, 50314, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
McFarland Clinic PC-Jefferson
Jefferson, Iowa, 50129, United States
McFarland Clinic PC-Marshalltown
Marshalltown, Iowa, 50158, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101, United States
Mercy Medical Center-Sioux City
Sioux City, Iowa, 51104, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Methodist West Hospital
West Des Moines, Iowa, 50266-7700, United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, 67905, United States
Cancer Center of Kansas-Manhattan
Manhattan, Kansas, 66502, United States
Cancer Center of Kansas - McPherson
McPherson, Kansas, 67460, United States
Cancer Center of Kansas - Newton
Newton, Kansas, 67114, United States
Menorah Medical Center
Overland Park, Kansas, 66209, United States
Saint Luke's South Hospital
Overland Park, Kansas, 66213, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, 67357, United States
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, 66208, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina, Kansas, 67401, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152, United States
Associates In Womens Health
Wichita, Kansas, 67208, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214, United States
Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Wichita NCI Community Oncology Research Program
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156, United States
Oncology Hematology Care Inc-Crestview
Crestview Hills, Kentucky, 41017, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Bixby Medical Center
Adrian, Michigan, 49221, United States
Hickman Cancer Center
Adrian, Michigan, 49221, United States
Green Bay Oncology - Escanaba
Escanaba, Michigan, 49829, United States
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, 49801, United States
Mercy Memorial Hospital
Monroe, Michigan, 48162, United States
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, 48162, United States
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, 56601, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview-Southdale Hospital
Edina, Minnesota, 55435, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
New Ulm Medical Center
New Ulm, Minnesota, 56073, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
Saint Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Southeast Cancer Center
Cape Girardeau, Missouri, 63703, United States
Centerpoint Medical Center LLC
Independence, Missouri, 64057, United States
Capital Region Medical Center-Goldschmidt Cancer Center
Jefferson City, Missouri, 65109, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
North Kansas City Hospital
Kansas City, Missouri, 64116, United States
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, 64118, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, 64086, United States
Liberty Radiation Oncology Center
Liberty, Missouri, 64068, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
Saint Joseph Oncology Inc
Saint Joseph, Missouri, 64507, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Saint Vincent Healthcare
Billings, Montana, 59101, United States
Montana Cancer Consortium NCORP
Billings, Montana, 59102, United States
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102, United States
Bozeman Deaconess Hospital
Bozeman, Montana, 59715, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Saint Peter's Community Hospital
Helena, Montana, 59601, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Montana Cancer Specialists
Missoula, Montana, 59802, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802, United States
CHI Health Saint Francis
Grand Island, Nebraska, 68803, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, 11570, United States
Memorial Sloan Kettering Sleepy Hollow
Sleepy Hollow, New York, 10591, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534, United States
Iredell Memorial Hospital
Statesville, North Carolina, 28677, United States
Southeast Clinical Oncology Research (SCOR) Consortium NCORP
Winston-Salem, North Carolina, 27104, United States
Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Sanford Clinic North-Fargo
Fargo, North Dakota, 58122, United States
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, 43402, United States
Oncology Hematology Care Inc-Eden Park
Cincinnati, Ohio, 45202, United States
Oncology Hematology Care Inc-Mercy West
Cincinnati, Ohio, 45211, United States
Oncology Hematology Care Inc - Anderson
Cincinnati, Ohio, 45230, United States
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236, United States
Oncology Hematology Care Inc-Blue Ash
Cincinnati, Ohio, 45242, United States
Grandview Hospital
Dayton, Ohio, 45405, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Samaritan North Health Center
Dayton, Ohio, 45415, United States
Dayton NCI Community Oncology Research Program
Dayton, Ohio, 45420, United States
Hematology Oncology Center Incorporated
Elyria, Ohio, 44035, United States
Mercy Cancer Center-Elyria
Elyria, Ohio, 44035, United States
Oncology Hematology Care Inc-Healthplex
Fairfield, Ohio, 45014, United States
Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Lima Memorial Hospital
Lima, Ohio, 45804, United States
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, 43537, United States
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, 43537, United States
Saint Charles Hospital
Oregon, Ohio, 43616, United States
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, 43616, United States
Flower Hospital
Sylvania, Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883, United States
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, 43606, United States
Saint Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
University of Toledo
Toledo, Ohio, 43614, United States
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, 43617, United States
Mercy Saint Anne Hospital
Toledo, Ohio, 43623, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, 43623, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Fulton County Health Center
Wauseon, Ohio, 43567, United States
Wright-Patterson Medical Center
Wright-Patterson Air Force Base, Ohio, 45433-5529, United States
Greene Memorial Hospital
Xenia, Ohio, 45385, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, 74136, United States
Warren Clinic Oncology-Tulsa
Tulsa, Oklahoma, 74146, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837, United States
Geisinger Medical Oncology-Pottsville
Pottsville, Pennsylvania, 17901, United States
Geisinger Medical Group
State College, Pennsylvania, 16801, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
McLeod Regional Medical Center
Florence, South Carolina, 29506, United States
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602, United States
University of Vermont College of Medicine
Burlington, Vermont, 05405, United States
Fredericksburg Oncology Inc
Fredericksburg, Virginia, 22401, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, 54301-3526, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, 54303, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, 54221, United States
Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
HSHS Saint Nicholas Hospital
Sheboygan, Wisconsin, 53081, United States
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235, United States
Rocky Mountain Oncology
Casper, Wyoming, 82609, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
Related Publications (1)
Dickson MA, Mahoney MR, Tap WD, D'Angelo SP, Keohan ML, Van Tine BA, Agulnik M, Horvath LE, Nair JS, Schwartz GK. Phase II study of MLN8237 (Alisertib) in advanced/metastatic sarcoma. Ann Oncol. 2016 Oct;27(10):1855-60. doi: 10.1093/annonc/mdw281. Epub 2016 Aug 8.
PMID: 27502708DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mark Andrew Dickson M.D.
- Organization
- Memorial Sloan Kettering Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Dickson
Alliance for Clinical Trials in Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2012
First Posted
July 30, 2012
Study Start
August 22, 2012
Primary Completion
August 2, 2015
Last Updated
November 30, 2017
Results First Posted
December 28, 2016
Record last verified: 2017-11