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Alisertib in Treating Patients With Advanced or Metastatic Sarcoma

Primary Purpose

Myxofibrosarcoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Leiomyosarcoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Alisertib
Laboratory Biomarker Analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myxofibrosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Arizona
  • The Medical Center of Aurora
  • Boulder Community Hospital
  • Rocky Mountain Cancer Centers-Boulder
  • Penrose-Saint Francis Healthcare
  • Rocky Mountain Cancer Centers-Penrose
  • Porter Adventist Hospital
  • Colorado Blood Cancer Institute
  • Presbyterian - Saint Lukes Medical Center - Health One
  • Rocky Mountain Cancer Centers-Midtown
  • SCL Health Saint Joseph Hospital
  • Rocky Mountain Cancer Centers-Rose
  • Rose Medical Center
  • Colorado Cancer Research Program NCORP
  • Mercy Medical Center
  • Comprehensive Cancer Care and Research Institute of Colorado LLC
  • Swedish Medical Center
  • Poudre Valley Hospital
  • Mountain Blue Cancer Care Center
  • North Colorado Medical Center
  • Rocky Mountain Cancer Centers-Greenwood Village
  • Rocky Mountain Cancer Centers-Lakewood
  • Saint Anthony Hospital
  • Littleton Adventist Hospital
  • Rocky Mountain Cancer Centers-Sky Ridge
  • Sky Ridge Medical Center
  • Longmont United Hospital
  • Rocky Mountain Cancer Centers-Longmont
  • McKee Medical Center
  • Parker Adventist Hospital
  • Rocky Mountain Cancer Centers-Parker
  • Saint Mary Corwin Medical Center
  • Rocky Mountain Cancer Centers - Pueblo
  • SCL Health Lutheran Medical Center
  • MedStar Washington Hospital Center
  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
  • Mayo Clinic in Florida
  • John B Amos Cancer Center
  • Hawaii Oncology Inc-Pali Momi
  • Pali Momi Medical Center
  • Hawaii Cancer Care Inc-POB II
  • Queen's Medical Center
  • Straub Clinic and Hospital
  • University of Hawaii Cancer Center
  • Hawaii Cancer Care Inc-Liliha
  • Hawaii Oncology Inc-Kuakini
  • Kapiolani Medical Center for Women and Children
  • Castle Medical Center
  • Wilcox Memorial Hospital and Kauai Medical Clinic
  • Kootenai Cancer Center
  • Northwestern University
  • Loyola University Medical Center
  • Garneau, Stewart C MD (UIA Investigator)
  • Porubcin, Michael MD (UIA Investigator)
  • Spector, David MD (UIA Investigator)
  • Trinity Medical Center
  • Carle Cancer Center
  • Reid Health
  • Mary Greeley Medical Center
  • McFarland Clinic PC-William R Bliss Cancer Center
  • Constantinou, Costas L MD (UIA Investigator)
  • McFarland Clinic PC-Boone
  • Medical Oncology and Hematology Associates-West Des Moines
  • Mercy Cancer Center-West Lakes
  • Iowa Methodist Medical Center
  • Iowa-Wide Oncology Research Coalition NCORP
  • Medical Oncology and Hematology Associates-Des Moines
  • Medical Oncology and Hematology Associates-Laurel
  • Mercy Medical Center - Des Moines
  • Iowa Lutheran Hospital
  • University of Iowa/Holden Comprehensive Cancer Center
  • McFarland Clinic PC-Jefferson
  • McFarland Clinic PC-Marshalltown
  • Siouxland Regional Cancer Center
  • Mercy Medical Center-Sioux City
  • Saint Luke's Regional Medical Center
  • Methodist West Hospital
  • Mercy Medical Center-West Lakes
  • Cancer Center of Kansas - Chanute
  • Cancer Center of Kansas - Dodge City
  • Cancer Center of Kansas - El Dorado
  • Cancer Center of Kansas - Fort Scott
  • Cancer Center of Kansas-Independence
  • Cancer Center of Kansas-Kingman
  • Lawrence Memorial Hospital
  • Cancer Center of Kansas-Liberal
  • Cancer Center of Kansas-Manhattan
  • Cancer Center of Kansas - McPherson
  • Cancer Center of Kansas - Newton
  • Menorah Medical Center
  • Saint Luke's South Hospital
  • Cancer Center of Kansas - Parsons
  • Kansas City NCI Community Oncology Research Program
  • Cancer Center of Kansas - Pratt
  • Cancer Center of Kansas - Salina
  • Cancer Center of Kansas - Wellington
  • Associates In Womens Health
  • Cancer Center of Kansas-Wichita Medical Arts Tower
  • Cancer Center of Kansas - Wichita
  • Via Christi Regional Medical Center
  • Wichita NCI Community Oncology Research Program
  • Cancer Center of Kansas - Winfield
  • Oncology Hematology Care Inc-Crestview
  • Boston Medical Center
  • Bixby Medical Center
  • Hickman Cancer Center
  • Green Bay Oncology - Escanaba
  • Green Bay Oncology - Iron Mountain
  • Mercy Memorial Hospital
  • Toledo Clinic Cancer Centers-Monroe
  • Sanford Clinic North-Bemidgi
  • Fairview Ridges Hospital
  • Mercy Hospital
  • Fairview-Southdale Hospital
  • Unity Hospital
  • Hutchinson Area Health Care
  • Minnesota Oncology Hematology PA-Maplewood
  • Saint John's Hospital - Healtheast
  • Abbott-Northwestern Hospital
  • Hennepin County Medical Center
  • New Ulm Medical Center
  • North Memorial Medical Health Center
  • Mayo Clinic
  • Coborn Cancer Center at Saint Cloud Hospital
  • Saint Cloud Hospital
  • Metro Minnesota Community Oncology Research Consortium
  • Park Nicollet Clinic - Saint Louis Park
  • Regions Hospital
  • United Hospital
  • Saint Francis Regional Medical Center
  • Lakeview Hospital
  • Ridgeview Medical Center
  • Rice Memorial Hospital
  • Minnesota Oncology Hematology PA-Woodbury
  • Southeast Cancer Center
  • Centerpoint Medical Center LLC
  • Capital Region Medical Center-Goldschmidt Cancer Center
  • Saint Luke's Hospital of Kansas City
  • North Kansas City Hospital
  • Heartland Hematology and Oncology Associates Incorporated
  • Research Medical Center
  • Saint Luke's East - Lee's Summit
  • Liberty Radiation Oncology Center
  • Heartland Regional Medical Center
  • Saint Joseph Oncology Inc
  • Washington University School of Medicine
  • Missouri Baptist Medical Center
  • Billings Clinic Cancer Center
  • Saint Vincent Healthcare
  • Montana Cancer Consortium NCORP
  • Saint Vincent Frontier Cancer Center
  • Bozeman Deaconess Hospital
  • Saint James Community Hospital and Cancer Treatment Center
  • Benefis Healthcare- Sletten Cancer Institute
  • Saint Peter's Community Hospital
  • Kalispell Regional Medical Center
  • Montana Cancer Specialists
  • Saint Patrick Hospital - Community Hospital
  • CHI Health Saint Francis
  • University of Nebraska Medical Center
  • Memorial Sloan Kettering Basking Ridge
  • Memorial Sloan Kettering Commack
  • Memorial Sloan-Kettering Cancer Center
  • Memorial Sloan Kettering Rockville Centre
  • Memorial Sloan Kettering Sleepy Hollow
  • Wayne Memorial Hospital
  • Iredell Memorial Hospital
  • Southeast Clinical Oncology Research (SCOR) Consortium NCORP
  • Roger Maris Cancer Center
  • Sanford Broadway Medical Center
  • Sanford Clinic North-Fargo
  • Toledo Clinic Cancer Centers-Bowling Green
  • Oncology Hematology Care Inc-Eden Park
  • Oncology Hematology Care Inc-Mercy West
  • Oncology Hematology Care Inc - Anderson
  • Oncology Hematology Care Inc-Kenwood
  • Oncology Hematology Care Inc-Blue Ash
  • Grandview Hospital
  • Good Samaritan Hospital - Dayton
  • Miami Valley Hospital
  • Samaritan North Health Center
  • Dayton NCI Community Oncology Research Program
  • Hematology Oncology Center Incorporated
  • Mercy Cancer Center-Elyria
  • Oncology Hematology Care Inc-Healthplex
  • Blanchard Valley Hospital
  • Atrium Medical Center-Middletown Regional Hospital
  • Wayne Hospital
  • Kettering Medical Center
  • Lima Memorial Hospital
  • Toledo Clinic Cancer Centers-Maumee
  • Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
  • Saint Charles Hospital
  • Toledo Clinic Cancer Centers-Oregon
  • Flower Hospital
  • Mercy Hospital of Tiffin
  • The Toledo Hospital/Toledo Children's Hospital
  • Saint Vincent Mercy Medical Center
  • University of Toledo
  • Toledo Community Hospital Oncology Program CCOP
  • Mercy Saint Anne Hospital
  • Toledo Clinic Cancer Centers-Toledo
  • Upper Valley Medical Center
  • Fulton County Health Center
  • Wright-Patterson Medical Center
  • Greene Memorial Hospital
  • University of Oklahoma Health Sciences Center
  • Natalie Warren Bryant Cancer Center at Saint Francis
  • Warren Clinic Oncology-Tulsa
  • Geisinger Medical Center
  • Geisinger Medical Center-Cancer Center Hazleton
  • Geisinger Medical Oncology-Lewisburg
  • Geisinger Medical Oncology-Pottsville
  • Geisinger Medical Group
  • Geisinger Wyoming Valley/Henry Cancer Center
  • Medical University of South Carolina
  • McLeod Regional Medical Center
  • Sanford Cancer Center-Oncology Clinic
  • Sanford USD Medical Center - Sioux Falls
  • Huntsman Cancer Institute/University of Utah
  • Central Vermont Medical Center/National Life Cancer Treatment
  • University of Vermont College of Medicine
  • Fredericksburg Oncology Inc
  • Green Bay Oncology at Saint Vincent Hospital
  • Saint Vincent Hospital Cancer Center Green Bay
  • Green Bay Oncology Limited at Saint Mary's Hospital
  • Saint Vincent Hospital Cancer Center at Saint Mary's
  • Holy Family Memorial Hospital
  • Bay Area Medical Center
  • Cancer Center of Western Wisconsin
  • Green Bay Oncology - Oconto Falls
  • HSHS Saint Nicholas Hospital
  • Green Bay Oncology - Sturgeon Bay
  • Rocky Mountain Oncology
  • Welch Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (alisertib)

Arm Description

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

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

Overall Survival (OS)
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).
Progression Free Survival (PFS)
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).
Adverse Events
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.

Full Information

First Posted
July 26, 2012
Last Updated
November 29, 2017
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01653028
Brief Title
Alisertib in Treating Patients With Advanced or Metastatic Sarcoma
Official Title
Phase II Study of MLN8237 in Advanced/Metastatic Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
August 22, 2012 (Actual)
Primary Completion Date
August 2, 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myxofibrosarcoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Leiomyosarcoma, Recurrent Liposarcoma, Recurrent Malignant Peripheral Nerve Sheath Tumor, Recurrent Undifferentiated Pleomorphic Sarcoma, Stage III Soft Tissue Sarcoma AJCC v7, Stage IV Soft Tissue Sarcoma AJCC v7

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (alisertib)
Arm Type
Experimental
Arm Description
Patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Alisertib
Other Intervention Name(s)
Aurora A Kinase Inhibitor MLN8237, MLN-8237, MLN8237
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
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.
Description
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%.
Time Frame
Up to 18 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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).
Time Frame
The time between registration and death, assessed up to 18 months
Title
Progression Free Survival (PFS)
Description
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).
Time Frame
The time between registration to disease progression or death, assessed up to 18 months
Title
Adverse Events
Description
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.
Time Frame
During treatment and up to 5 years

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
27502708
Citation
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.
Results Reference
derived

Learn more about this trial

Alisertib in Treating Patients With Advanced or Metastatic Sarcoma

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