Alisertib in Treating Patients With Advanced or Metastatic Sarcoma



Status:Completed
Conditions:Ovarian Cancer, Cancer, Cancer, Cancer, Cancer, Neurology, Hematology
Therapuetic Areas:Hematology, Neurology, Oncology
Healthy:No
Age Range:18 - Any
Updated:12/2/2017
Start Date:August 22, 2012

Use our guide to learn which trials are right for you!

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.

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.

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
We found this trial at
235
sites
929 N St Francis St
Wichita, Kansas 67214
(316) 268-5775
Via Christi Regional Medical Center Via Christi Health's rich history of serving the people of...
?
mi
from
Wichita, KS
Click here to add this to my saved trials
1 South Prospect Street
Burlington, Vermont 05401
802-656-8990
?
mi
from
Burlington, VT
Click here to add this to my saved trials
'Aiea, Hawaii 96701
?
mi
from
'Aiea, HI
Click here to add this to my saved trials
98-1079 Moanalua Road
'Aiea, Hawaii 96701
?
mi
from
'Aiea, HI
Click here to add this to my saved trials
818 Riverside Ave.
Adrian, Michigan 49221
(517) 265-0900
Bixby Medical Center ProMedica's Mission is to improve your health and well-being. Which is why,...
?
mi
from
Adrian, MI
Click here to add this to my saved trials
Adrian, Michigan 49221
?
mi
from
Adrian, MI
Click here to add this to my saved trials
1111 Duff Ave
Ames, Iowa 50010
(866) 972-5477
McFarland Clinic PC-William R Bliss Cancer Center The William R. Bliss Cancer Center at Mary...
?
mi
from
Ames, IA
Click here to add this to my saved trials
Ames, Iowa 50010
?
mi
from
Ames, IA
Click here to add this to my saved trials
1501 S Potomac St
Aurora, Colorado 80012
(303) 695-2600
Medical Center of Aurora At The Medical Center of Aurora and Centennial Medical Plaza patients...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Basking Ridge, New Jersey 07920
?
mi
from
Basking Ridge, NJ
Click here to add this to my saved trials
1300 Anne Street NW
Bemidji, Minnesota 56601
(218) 751-5430
Sanford Clinic North-Bemidgi Sanford Health is a voluntary, not-for-profit health care organization. Through its entities,...
?
mi
from
Bemidji, MN
Click here to add this to my saved trials
?
mi
from
Berlin, VT
Click here to add this to my saved trials
Bettendorf, Iowa 52722
?
mi
from
Bettendorf, IA
Click here to add this to my saved trials
Billings, Montana 59101
?
mi
from
Billings, MT
Click here to add this to my saved trials
Billings, Montana 59101
?
mi
from
Billings, MT
Click here to add this to my saved trials
1233 North 30th Street
Billings, Montana 59101
406-237-7000
Saint Vincent Healthcare The Sisters of Charity of Leavenworth, Kansas, founded St. Vincent Healthcare in...
?
mi
from
Billings, MT
Click here to add this to my saved trials
Billings, Montana 59102
?
mi
from
Billings, MT
Click here to add this to my saved trials
Boone, Iowa 50036
?
mi
from
Boone, IA
Click here to add this to my saved trials
Boston, Massachusetts 02118
?
mi
from
Boston, MA
Click here to add this to my saved trials
1100 Balsam Ave
Boulder, Colorado 80304
(303) 440-2273
Boulder Community Hospital Founded in 1922 as a community-owned and operated not-for-profit hospital, Boulder Community...
?
mi
from
Boulder, CO
Click here to add this to my saved trials
Boulder, Colorado 80303
?
mi
from
Boulder, CO
Click here to add this to my saved trials
960 W Wooster St
Bowling Green, Ohio 43402
419-353-5419
Toledo Clinic Cancer Centers-Bowling Green Our doctors evaluate and make recommendations regarding cancer treatment for...
?
mi
from
Bowling Green, OH
Click here to add this to my saved trials
915 Highland Blvd
Bozeman, Montana 59715
(406) 414-5000
Bozeman Deaconess Hospital Bozeman Deaconess Hospital is a Joint Commission certified, licensed Level III trauma...
?
mi
from
Bozeman, MT
Click here to add this to my saved trials
201 E Nicollet Blvd
Burnsville, Minnesota 55337
(952) 892-2000
Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
?
mi
from
Burnsville, MN
Click here to add this to my saved trials
400 South Clark Street
Butte, Montana 59701
406-723-2500
Saint James Community Hospital and Cancer Treatment Center St. James Healthcare has played an important...
?
mi
from
Butte, MT
Click here to add this to my saved trials
789 Mt Auburn Rd
Cape Girardeau, Missouri 63703
(573) 519-4725
Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
?
mi
from
Cape Girardeau, MO
Click here to add this to my saved trials
6501 E 2nd St
Casper, Wyoming 82609
(307) 235-5433
Rocky Mountain Oncology Rocky Mountain Oncology Center is a spacious, comfortable, state-of-the-art 19,000 square foot...
?
mi
from
Casper, WY
Click here to add this to my saved trials
505 S Plummer Ave
Chanute, Kansas 66720
(620) 431-7580
Cancer Center of Kansas, PA - Chanute Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Chanute, KS
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
12495 University Ave
Clive, Iowa 50325
(515) 358-9700
Mercy Cancer Center - West Lakes When it comes to cancer care, there
?
mi
from
Clive, IA
Click here to add this to my saved trials
?
mi
from
Clive, IA
Click here to add this to my saved trials
Colorado Springs, Colorado 80907
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
6001 E Woodmen Rd
Colorado Springs, Colorado 80923
(719) 776-5000
Penrose-Saint Francis Healthcare Founded by the Sisters of St. Francis and the Sisters of Charity,...
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
1831 Fifth Avenue
Columbus, Georgia 31904
(706) 320-8700
John B. Amos Cancer Center The John B. Amos Cancer Center located in Columbus, Georgia,...
?
mi
from
Columbus, GA
Click here to add this to my saved trials
Commack, New York 11725
?
mi
from
Commack, NY
Click here to add this to my saved trials
4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
(763) 236-6000
Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
?
mi
from
Coon Rapids, MN
Click here to add this to my saved trials
Crestview Hills, Kentucky 41017
?
mi
from
Crestview Hills, KY
Click here to add this to my saved trials
100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
?
mi
from
Danville, PA
Click here to add this to my saved trials
1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
Miami Valley Hospital Miami Valley Hospital (MVH) is passionate about providing the most recent medical...
?
mi
from
Dayton, OH
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
405 W Grand Ave
Dayton, Ohio 45405
(937) 723-3200
Grandview Hospital You'll feel like part of our family when you visit Grandview Medical Center...
?
mi
from
Dayton, OH
Click here to add this to my saved trials
2222 Philadelphia Dr
Dayton, Ohio 45406
(937) 734-2612
Good Samaritan Hospital - Dayton Good Samaritan Hospital (GSH) is passionate about providing the most...
?
mi
from
Dayton, OH
Click here to add this to my saved trials
9000 N. Main St.
Dayton, Ohio 45415
(937) 734-6784
Samaritan North Health Center Good Samaritan Hospital (GSH) is passionate about providing the most recent...
?
mi
from
Dayton, OH
Click here to add this to my saved trials
4567 E 9th Ave
Denver, Colorado 80220
(303) 320-2121
Rose Medical Center Well known as a Denver institution and a 9th Avenue landmark for...
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
Denver, Colorado 80220
?
mi
from
Denver, CO
Click here to add this to my saved trials
2525 S Downing St
Denver, Colorado 80210
(303) 778-1955
Porter Adventist Hospital Founded in 1930, Porter Adventist Hospital has provided people throughout Denver and...
?
mi
from
Denver, CO
Click here to add this to my saved trials
1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
720-754-4800
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
Denver, Colorado 80218
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
1111 6th Ave
Des Moines, Iowa 50314
(515) 247-3121
Mercy Medical Center - Des Moines Mercy Medical Center
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
1200 Pleasant St
Des Moines, Iowa 50309
(515) 241-6212
Iowa Methodist Medical Center Iowa Methodist Medical Center was established in 1901 in a single...
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
700 E University Ave
Des Moines, Iowa 50316
(515) 263-5612
Iowa Lutheran Hospital Iowa Lutheran Hospital has a long history of serving the Des Moines...
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
2020 Central Ave
Dodge City, Kansas 67801
(620) 227-2488
Cancer Center of Kansas, PA - Dodge City Dr. H.E. Hynes founded Cancer Center of...
?
mi
from
Dodge City, KS
Click here to add this to my saved trials
Durango, Colorado 81301
?
mi
from
Durango, CO
Click here to add this to my saved trials
6401 France Ave S
Edina, Minnesota 55435
(952) 924-5000
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
?
mi
from
Edina, MN
Click here to add this to my saved trials
700 West Central
El Dorado, Kansas 67042
(316) 889-0099
Cancer Center of Kansas, PA - El Dorado Dr. H.E. Hynes founded Cancer Center of...
?
mi
from
El Dorado, KS
Click here to add this to my saved trials
Elyria, Ohio 44035
?
mi
from
Elyria, OH
Click here to add this to my saved trials
?
mi
from
Elyria, OH
Click here to add this to my saved trials
501 E. Hampden Ave.
Englewood, Colorado 80113
303-788-5000
?
mi
from
Englewood, CO
Click here to add this to my saved trials
?
mi
from
Englewood, CO
Click here to add this to my saved trials
3401 Ludington St
Escanaba, Michigan 49829
(800) 432-6049
Green Bay Oncology - Escanaba We are one of a select few physician groups in...
?
mi
from
Escanaba, MI
Click here to add this to my saved trials
?
mi
from
Fairfield, OH
Click here to add this to my saved trials
801 Broadway North
Fargo, North Dakota 58122
?
mi
from
Fargo, ND
Click here to add this to my saved trials
820 4th St N
Fargo, North Dakota 58102
(701) 234-6161
Roger Maris Cancer Center Sanford Health is an integrated health system headquartered in the Dakotas...
?
mi
from
Fargo, ND
Click here to add this to my saved trials
2601 Broadway
Fargo, North Dakota 58102
(701) 234-2900
Sanford Clinic North-Fargo Sanford Health is an integrated health system headquartered in the Dakotas and...
?
mi
from
Fargo, ND
Click here to add this to my saved trials
1900 S Main St
Findlay, Ohio 45840
(419) 423-4500
Blanchard Valley Hospital For more than 100 years, Blanchard Valley Hospital has made quality care...
?
mi
from
Findlay, OH
Click here to add this to my saved trials
555 East Cheves Street
Florence, South Carolina 29506
843-777-2000
McLeod Regional Medical Center McLeod Health, a regional presence and predominant healthcare organization, is dedicated...
?
mi
from
Florence, SC
Click here to add this to my saved trials
1024 S Lemay Ave
Fort Collins, Colorado 80524
(970) 495-7000
Poudre Valley Hospital A 270-bed regional medical center offering a wide array of treatments, surgeries,...
?
mi
from
Fort Collins, CO
Click here to add this to my saved trials
Fort Scott, Kansas 66701
(620) 223-8589
Cancer Center of Kansas - Fort Scott Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Fort Scott, KS
Click here to add this to my saved trials
One Medical Center Drive
Franklin, Ohio 45005
(513) 424-2111
Atrium Medical Center - Middletown Regional Hospital Atrium Medical Center (Atrium) is built on the...
?
mi
from
Franklin, OH
Click here to add this to my saved trials
1500 Dixon St #203
Fredericksburg, Virginia 22401
(540) 368-0500
Fredericksburg Oncology Inc Fredericksburg Oncology is dedicated to offering each patient individual care and attention...
?
mi
from
Fredericksburg, VA
Click here to add this to my saved trials
550 Osborne Rd NE
Fridley, Minnesota 55432
(763) 236-5000
Unity Hospital Unity Hospital is one of the Twin Cities
?
mi
from
Fridley, MN
Click here to add this to my saved trials
Golden, Colorado 80401
?
mi
from
Golden, CO
Click here to add this to my saved trials
2700 Wayne Memorial Dr
Goldsboro, North Carolina 27534
(919) 736-1110
Wayne Memorial Hospital Wayne Memorial Hospital, an affiliate of Wayne Health Corporation, is home to...
?
mi
from
Goldsboro, NC
Click here to add this to my saved trials
Grand Island, Nebraska 68803
?
mi
from
Grand Island, NE
Click here to add this to my saved trials
1117 29th St S
Great Falls, Montana 59405
(406) 771-7300
Benefis Healthcare- Sletten Cancer Institute Benefis Hospitals has 516 beds at its two campuses (that...
?
mi
from
Great Falls, MT
Click here to add this to my saved trials
1801 16th St
Greeley, Colorado 80631
(970) 352-4121
North Colorado Medical Center NCMC is a fully accredited, private, non-profit facility licensed to operate...
?
mi
from
Greeley, CO
Click here to add this to my saved trials
835 S Van Buren St
Green Bay, Wisconsin 54301
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
1726 Shawano Avenue
Green Bay, Wisconsin 54303
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
835 S. Van Buren St.
Green Bay, Wisconsin 54301
(920) 884-3135
Green Bay Oncology at Saint Vincent Hospital We are one of a select few physician...
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
1726 Shawano Ave.
Green Bay, Wisconsin 54303
(920) 884-3135
Green Bay Oncology Limited at Saint Mary's Hospital We are one of a select few...
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
835 Sweitzer St
Greenville, Ohio 45331
(937) 548-1141
Wayne Hospital Stretching back to our roots nearly 100 years ago, Wayne HealthCare has always...
?
mi
from
Greenville, OH
Click here to add this to my saved trials
Greenwood Village, Colorado 80111
?
mi
from
Greenwood Village, CO
Click here to add this to my saved trials
?
mi
from
Hazleton, PA
Click here to add this to my saved trials
Helena, Montana 59601
?
mi
from
Helena, MT
Click here to add this to my saved trials
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
1319 Punahou St
Honolulu, Hawaii 96826
(808) 983-6000
Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
1301 Punchbowl St
Honolulu, Hawaii 96813
(808) 538-9011
Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
888 S King St
Honolulu, Hawaii 96813
(808) 522-4000
Straub Clinic And Hospital Founded in 1921, Straub Clinic & Hospital is a fully integrated...
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
Honolulu, Hawaii 96813
?
mi
from
Honolulu, HI
Click here to add this to my saved trials