Phase II Study of the Angiopoietin-1 and -2 Peptibody AMG 386 for the Treatment of Angiosarcoma
PRIMARY OBJECTIVES:
I. To determine the overall response rate (ORR), defined as complete response (CR) +partial
response (PR), in patients with advanced, unresectable angiosarcoma treated with trebananib
(AMG 386).
SECONDARY OBJECTIVES:
I. To evaluate the progression-free survival (PFS) and overall survival (OS) of patients
with advanced, unresectable angiosarcoma treated with AMG 386.
TERTIARY OBJECTIVES:
I. To correlate ORR, PFS, and OS with: Baseline and post-treatment changes in expression of
angiopoietin 2 (Ang2) and TEK tyrosine kinase, endothelial (Tie2) by immunohistochemistry
(IHC); Serum levels of angiopoietin 1 (Ang1) and Ang2; Baseline and post-treatment changes
in phospho-receptor tyrosine kinase status of TIE2, vascular endothelial growth factor
receptor 2 (VEGFR-2), phosphatidylinositol 3 kinase (PI3K), mitogen-activated protein kinase
Inhibitor (MEK) in tumor tissue; Mutational status of VEGFR-2 and amplification of v-myc
myelocytomatosis viral oncogene homolog (avian) (MYC)/fms-related tyrosine kinase 4 (FLT4).
OUTLINE: This is a multicenter study.
Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
Patients may undergo blood sample collection at baseline and periodically during treatment
for correlative studies. Tumor tissue samples may be also collected.
After completion of study treatment, patients are followed up for 4 weeks and then every 6
months for 18 months.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Confirmed response rate (CR or PR) using RECIST
The 95% confidence intervals should be provided using the method of Duffy and Santner.
Up to 18 months
No
Sandra D'Angelo
Principal Investigator
Cancer and Leukemia Group B
United States: Food and Drug Administration
NCI-2012-01978
NCT01623869
July 2012
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Mayo Clinic | Rochester, Minnesota 55905 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Beebe Medical Center | Lewes, Delaware 19958 |
Memorial Hospital | Carthage, Illinois 62321 |
Galesburg Clinic | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Proctor Hospital | Peoria, Illinois 61614 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
Grandview Hospital | Dayton, Ohio 45405 |
Eureka Hospital | Eureka, Illinois 61530 |
Graham Hospital Association | Canton, Illinois 61520 |
Holy Family Medical Center | Des Plaines, Illinois 60016 |
Saint Joseph Medical Center | Joliet, Illinois 60435 |
Miami Valley Hospital | Dayton, Ohio 45409 |
Wayne Hospital | Greenville, Ohio 45331 |
Greene Memorial Hospital | Xenia, Ohio 45385 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
Washington Hospital Center | Washington, District of Columbia 20010 |
Queen's Medical Center | Honolulu, Hawaii 96813 |
Northwestern University | Chicago, Illinois 60611 |
Kapiolani Medical Center at Pali Momi | Aiea, Hawaii 96701 |
Kapiolani Medical Center for Women and Children | Honolulu, Hawaii 96826 |
Straub Clinic and Hospital | Honolulu, Hawaii 96813 |
Castle Medical Center | Kailua, Hawaii 96734 |
OSF Saint Francis Medical Center | Peoria, Illinois 61637 |
Oncare Hawaii Inc-POB II | Honolulu, Hawaii 96813 |
Oncare Hawaii Inc-Kuakini | Honolulu, Hawaii 96817 |
University of Hawaii | Honolulu, Hawaii 96813 |
Community Cancer Center Foundation | Normal, Illinois 61761 |
Illinois CancerCare-Ottawa Clinic | Ottawa, Illinois 61350 |
Ottawa Regional Hospital and Healthcare Center | Ottawa, Illinois 61350 |
Pekin Cancer Treatment Center | Pekin, Illinois 61554 |
Illinois Oncology Research Association CCOP | Peoria, Illinois 61615 |
Illinois CancerCare-Peoria | Peoria, Illinois 61615 |
Illinois Valley Hospital | Peru, Illinois 61354 |
Reid Hospital and Health Care Services | Richmond, Indiana 47374 |
Mercy Medical Center-Sioux City | Sioux City, Iowa 51104 |
Saint Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Cooper Hospital University Medical Center | Camden, New Jersey 08103 |
Good Samaritan Hospital - Dayton | Dayton, Ohio 45406 |
Dayton CCOP | Dayton, Ohio 45429 |
Samaritan North Health Center | Dayton, Ohio 45415 |
Blanchard Valley Hospital | Findlay, Ohio 45840 |
Atrium Medical Center-Middletown Regional Hospital | Franklin, Ohio 45005-1066 |
Kettering Medical Center | Kettering, Ohio 45429 |
Upper Valley Medical Center | Troy, Ohio 45373 |
Illinois CancerCare-Bloomington | Bloomington%, Illinois 61701 |
Illinois CancerCare-Canton | Canton, Illinois 61520 |
Illinois CancerCare-Carthage | Carthage, Illinois 62321 |
Illinois CancerCare-Eureka | Eureka, Illinois 61530 |
Illinois CancerCare-Havana | Havana, Illinois 62644 |
Illinois CancerCare-Kewanee Clinic | Kewanee, Illinois 61443 |
Illinois CancerCare-Macomb | Macomb, Illinois 61455 |
Illinois CancerCare-Monmouth | Monmouth, Illinois 61462 |
Illinois CancerCare-Community Cancer Center | Normal, Illinois 61761 |
Illinois CancerCare-Pekin | Pekin, Illinois 61603 |
Illinois CancerCare-Peru | Peru, Illinois 61354 |
Illinois CancerCare-Princeton | Princeton, Illinois 61356 |
Illinois CancerCare-Spring Valley | Spring Valley, Illinois 61362 |
Wilcox Memorial Hospital and Kauai Medical Clinic | Lihue, Hawaii 96766-1099 |
Siouxland Hematology Oncology Associates | Sioux City, Iowa 51101 |
Carle Foundation - Carle Cancer Center | Urbana, Illinois 61801 |
Franciscan St. Francis Health | Indianapolis, Indiana 46237 |
Christiana Care Health System-Christiana Hospital | Newark, Delaware 19718 |
Oncare Hawaii Inc - Kapiolani Medical Center at Pali Momi | Aiea, Hawaii 96701 |